Trials (Sahlgrenska University Hospital)

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NCTID: NCT03685890

Title: Evaluating the Effect of Nivolumab for Patients With In-transit Metastases Treated With Isolated Limb Perfusion 
Study Summary: To evaluate safety and the effect of isolated limb perfusion together with nivolumab as a way to increase efficacy and give further insights in early immunological mechanisms.  In the first phase Ib part, 20 patients will be enrolled and followed for a minimum of 3 months. An independent data safety monitoring board (DSMB) will continuously review safety and judge the seriousness of the events and also recommend the study to stop if necessary. If the DSMB do not find safety issues, the trial will continue as a phase II trial. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Nivolumab 
Start Date: 2019-04-01 
Last Updated: 2023-11-22 
Number of Patients: 74 
Recruitment Status: RECRUITING 
Condition: Melanoma 

NCTID: NCT00036556

Title: Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer 
Study Summary: This study is being done to evaluate the safety and efficacy of atrasentan in men with non-metastatic hormone-refractory prostate cancer. 
Sponsor: Abbott 
Intervention: Atrasentan 
Start Date: 2001-06 
Last Updated: 2007-08-15 
Number of Patients: 941 
Recruitment Status: COMPLETED 
Condition: Prostatic Neoplasms 

NCTID: NCT05387603

Title: Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors. 
Study Summary: There are several ways of personalizing PRRT (peptide receptor radionuclide treatment) in NEN (neuroendocrine neoplasia). Nevertheless, the current treatment regimen is not personalized. This trial aims to compare personalized PRRT to non-personalized PRRT in terms of safety, efficacy and resource demands in order to optimize treatment outcomes in an evidence-based manner in future. 
Sponsor: Lund University Hospital 
Intervention: 177Lu-DOTATOC 
Start Date: 2022-06 
Last Updated: 2022-05-24 
Number of Patients: 300 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Neuroendocrine Tumors 

NCTID: NCT01356290

Title: Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma and ATRT 
Study Summary: Patients with relapsed medulloblastoma, ependymoma and ATRT have a very poor prognosis whether treated with conventional chemotherapy, high-dose chemotherapy with stem cell rescue, irradiation or combinations of these modalities. Antiangiogenetic therapy has emerged as new treatment option in solid malignancies. The frequent, metronomic schedule targets both proliferating tumor cells and endothelial cells, and minimizes toxicity. In this study the investigators will evaluate the use of biweekly intravenous bevacizumab in combination with five oral drugs (thalidomide, celecoxib, fenofibrate, and alternating cycles of daily low-dose oral etoposide and cyclophosphamide), augmented with alternating courses of intrathecal etoposide and cytarabine. The aim of the study is to extend therapy options for children with recurrent or progressive medulloblastoma, ependymoma and ATRT, for whom no known curative therapy exists, by prolonging survival while maintaining good quality of life. The primary objective of the MEMMAT trial is to evaluate the activity of this multidrug antiangiogenic approach in these heavily pretreated children and young adults. Additionally, progression-free survival (PFS), overall survival (OS), as well as feasibility and toxicity will be examined. 
Sponsor: Medical University of Vienna 
Intervention: Bevacizumab 
Start Date: 2014-04 
Last Updated: 2023-04-21 
Number of Patients: 100 
Recruitment Status: RECRUITING 
Condition: Medulloblastoma Recurrent 

NCTID: NCT04534075

Title: Dietary Fiber During Radiotherapy - a Placebo-controlled Randomized Trial 
Study Summary: The investigators hypothesize that an increase in dietary fiber intake during radiation therapy may provide better long-term intestinal health for the cancer survivor. If the hypothesis is not correct, the increased intake may only mean an increase in acute side effects. All participants are advised to consume at least 16 g of dietary fiber/day via food. In addition, participants are invited to take capsules that together contain either 5.5 g of dietary fiber from psyllium husk or placebo. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Capsules containing either dietary fiber or placebo 
Start Date: 2020-09-02 
Last Updated: 2023-05-01 
Number of Patients: 600 
Recruitment Status: RECRUITING 
Condition: Malignant Neoplasm 

NCTID: NCT04219254

Title: A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (KEYNOTE-A04) 
Study Summary: Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors Previously Treated with Anti-PD-1 or Anti-PD-L1 Antibodies 
Sponsor: BioInvent International AB 
Intervention: BI1206 
Start Date: 2020-06-29 
Last Updated: 2023-11-24 
Number of Patients: 90 
Recruitment Status: RECRUITING 
Condition: Solid Tumor, Adult 

NCTID: NCT04908956

Title: Osimertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR Mutant NSCLC (STEREO) 
Study Summary: STEREO is single-arm phase II study, which aims to evaluate the safety and efficacy of osimertinib combined with early locally ablative radiotherapy of all cancer sites in patients with synchronous oligo-metastatic (primary tumour and maximum 5 metastases) EGFR-mutant (exon 19 deletion or exon 21 L858R) NSCLC. Eradication of all macroscopic cancer sites at the time of primary diagnosis by combined modality treatment is expected to decrease the risk of resistance development with only microscopic disease potentially remaining. This will result in an improvement of PFS and OS without added high-grade toxicity. 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: Osimertinib 
Start Date: 2022-08-04 
Last Updated: 2023-11-02 
Number of Patients: 6 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: NSCLC Stage IV 

NCTID: NCT01077050

Title: SciBase International Melanoma Pivotal Study 
Study Summary: The purpose of this clinical investigation was to determine the safety and effectiveness of the SciBase III device (Test) designed to help distinguish between malignant melanoma and benign lesions, using electrical impedance spectroscopy (EIS) relative to the histological gold standard (Reference).  The purpose of the study is to collect data to support a Pre-market Application(PMA) to obtain Food and Drug Administration(FDA) approval to market the SciBase III Electrical Impedance Spectrometer. 
Sponsor: SciBase AB 
Intervention: SciBase III Electrical Impedance Spectrometer 
Start Date: 2010-04 
Last Updated: 2013-12-30 
Number of Patients: 1951 
Recruitment Status: COMPLETED 
Condition: Malignant Melanoma 

NCTID: NCT02279654

Title: Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q) 
Study Summary: This registry is a prospective, non-interventional, post authorisation safety study for patients diagnosed with Transfusion Dependent, IPSS low or intermediate-1-Risk Myelodysplastic Syndrome (MDS), associated to a single abnormality of the chromosome 5 <math display="block">del(5q)</math>.  The purpose of this study is to collect additional data about the safety of an oral drug (lenalidomide, Revlimid®) that may have been prescribed to relieve anemia and decrease the need of blood transfusions. However, also patients affected by the MDS del(5q) who receive other treatments different from lenalidomide can be included in this study, if they agree. 
Sponsor: Celgene 
Intervention: Lenalidomide 
Start Date: 2014-12-17 
Last Updated: 2022-08-19 
Number of Patients: 389 
Recruitment Status: COMPLETED 
Condition: Myelodysplastic Syndrome 

NCTID: NCT02907359

Title: Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs 
Study Summary: A Phase 3, randomized, open-label, parallel-group, multicenter study designed to evaluate the efficacy and safety of guadecitabine in participants with MDS or CMML who failed or relapsed after adequate prior treatment with azacitidine, decitabine, or both. This global study will be conducted in approximately 15 countries. Approximately 408 participants from approximately 100 study centers will be randomly assigned in a 2:1 ratio to either guadecitabine (approximately 272 participants) or Treatment Choice (approximately 136 participants). The study consists of a 21-day screening period, a treatment period, a safety follow-up visit, and a long-term follow-up period. The study is expected to last more than 2 years, and the duration of individual participant participation will vary. Participants may continue to receive treatment for as long as they continue to benefit. 
Sponsor: Astex Pharmaceuticals, Inc. 
Intervention: Guadecitabine 
Start Date: 2017-01-13 
Last Updated: 2023-05-18 
Number of Patients: 417 
Recruitment Status: COMPLETED 
Condition: Myelodysplastic Syndromes 

NCTID: NCT05876754

Title: An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma 
Study Summary: A Phase 3b research study to consolidate the data that ivosidenib is safe and effective in adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma (CCA). All patients who meet inclusion criteria will be enrolled to receive ivosidenib tablets orally once daily for 28 day cycles, continuing as long as clinical benefit and consent for participation is maintained. There will be a minimum of 6 study visits from screening until the final follow-up, if one cycle of treatment is completed and consent is maintained through 18 months of follow-up. Each additional cycle completed will add one study visit, on the first day of each cycle. 
Sponsor: Servier Affaires Médicales 
Intervention: Ivosidenib Oral Tablet 
Start Date: 2023-05-03 
Last Updated: 2023-09-06 
Number of Patients: 220 
Recruitment Status: RECRUITING 
Condition: Cholangiocarcinoma 

NCTID: NCT05082675

Title: Stem Cell Translpantation in Multiple Myeloma 
Study Summary: The purpose of this study is to determine whether autologous transplantation (using the patient’s own stem cells from the blood), followed by non-myeloablative (i.e. less intense) allogeneic transplantation (where the blood stem cells from a sibling donor are used for the transplantation) improves the outcome in patients with newly diagnosed multiple myeloma. 
Sponsor: European Society for Blood and Marrow Transplantation 
Intervention: HLA Matched allogeneic transplant 
Start Date: 2001-09 
Last Updated: 2023-09-11 
Number of Patients: 357 
Recruitment Status: COMPLETED 
Condition: Multiple Myeloma 

NCTID: NCT00472459

Title: PDT With Metvix® 160 mg/g Cream in Organ Transplant Recipients With Non-melanoma Skin Cancer 
Study Summary: Patients on immunosuppressive therapy, e.g. organ recipients, have a higher occurrence of AK than the untreated population. Keratotic lesions (i.e. AK lesions and warts) in this population is highly associated with development of SCC also with 10 times higher mortality rate because of SCC than expected. The risk of developing skin cancer, predominantly SCC and BCC, increases with graft survival time and the length of immunosuppressive treatment period.  The higher risk of developing skin malignancy and more aggressive skin malignancies in this population, indicate the need for early removal of these pre-malignant lesions.  In this study, two contralateral areas (5x10 cm2) with skin lesions within the patient will be compared. One area will receive Metvix PDT at defined intervals and the other will receive lesion specific treatment at the discretion of the investigator. The primary end-point will be the accumulated number of new lesions during the study and number of AK lesions that show complete response 3 months after baseline. Secondary endpoints will be number of BCC lesions that show complete response, number of recurrent lesions, assessment of cosmetic outcome and safety. 
Sponsor: Galderma R&D 
Intervention: Photodynamic therapy with Metvix 160 mg/g cream 
Start Date: 2003-07 
Last Updated: 2021-02-18 
Number of Patients: 81 
Recruitment Status: COMPLETED 
Condition: Actinic Keratosis 

NCTID: NCT05377047

Title: Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer 
Study Summary: TAORMINA is an international, multicentre, randomised phase 3 trial for patients with oligometastatic breast cancer (OMBC) that will be allocated to combined stereotactic ablative radiotherapy (SABR) + systemic therapy (investigational arm) versus systemic therapy alone (control arm) as 1st line therapy. 
Sponsor: Vastra Gotaland Region 
Intervention: SABR 
Start Date: 2022-09-19 
Last Updated: 2022-10-21 
Number of Patients: 345 
Recruitment Status: RECRUITING 
Condition: Breast Cancer Stage IV 

NCTID: NCT00424047

Title: A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma 
Study Summary: To compare the efficacy of oral CC-5013 in combination with oral pulse high-dose dexamethasone to that of placebo and oral high-dose pulse dexamethasone as treatment for subjects with relapsed or refractory multiple myeloma." 
Sponsor: Celgene 
Intervention: CC-5013 plus dexamethasone 
Start Date: 2003-01-01 
Last Updated: 2017-10-19 
Number of Patients: 351 
Recruitment Status: COMPLETED 
Condition: Multiple Myeloma 

NCTID: NCT01208766

Title: Study to Compare VMP With HDM Followed by VRD Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma 
Study Summary: Study phase: phase III  Study objective:  * Comparison of Bortezomib, Melphalan, Prednisone (VMP) with High Dose Melphalan followed autologous stem cell transplantation (ASCT) * Comparison of Bortezomib, Lenalidomide, Dexamethasone(VRD) as consolidation versus no consolidation * Comparison of single versus tandem high dose Melphalan with ASCT  Patient population: Patients with symptomatic multiple myeloma,previously untreated, ISS stages 1-3, age 18-65 years inclusive  Study design: Prospective, multicenter, intergroup, randomized  Duration of treatment: Expected duration of induction, stem cell collection and intensification is 6 - 9 months. Consolidation with VRD will last 2 months Maintenance therapy with Lenalidomide will be given until relapse. All patients will be followed until 10 years after registration. 
Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland 
Intervention: Bortezomib, Melphalan, Prednisone (VMP) 
Start Date: 2011-01 
Last Updated: 2023-08-22 
Number of Patients: 1503 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Multiple Myeloma 

NCTID: NCT02797366

Title: Proton Radiotherapy for Primary Central Nervous System Tumours in Adults 
Study Summary: Open label, multi-centre prospective study. Adult patients with primary central nervous system tumours fulfilling the inclusion criteria according to the study protocol. The study consists of 2 sequential cohorts evaluated consecutively for the feasibility, safety and toxicity, as well as long-term survival data, when using spot scanning proton beam therapy. 
Sponsor: Uppsala University 
Intervention: Proton radiotherapy 
Start Date: 2015-08 
Last Updated: 2016-06-13 
Number of Patients: 500 
Recruitment Status: RECRUITING 
Condition: Central Nervous System Tumour 

NCTID: NCT01323166

Title: Quality of Life After Abdominoperineal Resection for Rectal Cancer, Comparing Two Surgical Techniques 
Study Summary: The purpose of the study is to compare self-reported health related quality of life after two different operating techniques for low rectal cancer operated by rectal amputation, using a specific and detailed questionnaire. The population has been operated over a 6 year period in one university hospital. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Excision of the levator muscle 
Start Date: 2011-03 
Last Updated: 2015-09-04 
Number of Patients: 75 
Recruitment Status: COMPLETED 
Condition: Rectal Cancer 

NCTID: NCT03820986

Title: Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advance Melanoma (MK-7902-003/E7080-G000-312/LEAP-003) 
Study Summary: The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) as first-line treatment in adults with no prior systemic therapy for their advanced melanoma.  The primary study hypotheses are that: 1) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), and 2) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Overall Survival (OS). For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2019-03-12 
Last Updated: 2023-04-25 
Number of Patients: 674 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Malignant Melanoma 

NCTID: NCT02302807

Title: A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211] 
Study Summary: This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen. The anticipated time on study treatment is based on continued clinical benefit, i.e., until disease progression or unacceptable toxicity. The target sample size is 931 participants. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody 
Start Date: 2015-01-13 
Last Updated: 2019-08-01 
Number of Patients: 931 
Recruitment Status: COMPLETED 
Condition: Bladder Cancer 

NCTID: NCT00376883

Title: Pamidronate Prophylaxis in Multiple Myeloma 30 mg/Month Versus 90 mg/Month 
Study Summary: Multiple myeloma is a malignant hematological disease dominated by monoclonal plasma cells in the bone marrow. Major symptoms are related to the bones due to an increased bone resorption and a decreased bone formation leading to bone pain and increased risk of fractures. The normal osteoclasts are responsible for bone degradation through stimulation from the malignant plasma cells. Bisphosphonates have been shown to inhibit the osteoclast activity but may have serious side-effects due to renal toxicity and the optimal dose have not been established.  In a randomized double blinded design it is aim to compare the standard of monthly injections of 90 mg pamidronate with 30 mg.  The primary end-point is physical function estimated by EORTC QLQ-C30 questionnaire at 12 months after starting the treatment in newly diagnosed treatment demanding multiple myeloma. Secondary end-points are skeletal related events, cost-utility analysis, response, response duration and survival and quality of life with respect to fatigue and pain. 
Sponsor: Nordic Myeloma Study Group 
Intervention: pamidronate 
Start Date: 2000-01 
Last Updated: 2007-01-04 
Number of Patients: 500 
Recruitment Status: COMPLETED 
Condition: Multiple Myeloma 

NCTID: NCT03125343

Title: Watch and Wait as Treatment for Patients With Rectal Cancer 
Study Summary: A national cohort study with all patients scheduled for neoadjuvant treatment with (chemo)radiotherapy or short course radiotherapy with delayed surgery 6-8 weeks) for rectal cancer staged as cT4bNX/anycTanycN and cMRF+/anycTanycN and lateral lymph nodes on MRI (and patients that have been offered short course raditotherapy with delayed surgery due to various reasons). The tumours are positioned midrectal or low and are palpable with the finger. The patients offered this treatment after recommendations on their local multidisciplinary tumour board will be will be informed and offered to participate in the study. Patients scheduled for short course radiotherapy with immediate surgery cannot be included. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: endoscopy 
Start Date: 2017-01 
Last Updated: 2023-11-07 
Number of Patients: 400 
Recruitment Status: RECRUITING 
Condition: Rectal Neoplasms 

NCTID: NCT04771507

Title: A Pilot Study on Intermittent Ibrutinib in Patients With Advanced-phase Chronic Lymphocytic Leukemia (CLL) 
Study Summary: Ibrutinib, an inhibitor of Bruton´s tyrosine kinase (BTK) is approved in CLL as continuous, daily administration of 420 mg orally until progression. Ibrutinib drug costs in health care are rapidly increasing and are difficult to predict, as long-term follow up analyses have shown that many patients remain on therapy for several years, in some cases even many years. It has been observed that patients who stop ibrutinib due to side effects may often remain with continued CLL disease control i.e. in stable partial remission even when off ibrutinib therapy. There are also emerging data on mutations within BTK, with loss of efficacy of ibrutinib, during long-term continuous administration. These observations raise the question whether alternative dosing strategies may be feasible. This pilot study will explore intermittent and repeated dosing of ibrutinib, until alternative therapy is required due to resistance or intolerance to ibrutinib. An “ON-OFF” dosing strategy will be applied, where advanced-phase CLL patients who have received at least 6 months of ibrutinib and who have achieved a stable PR will stop ibrutinib and be followed off therapy until clinical progression, at which ibrutinib will be re-instituted. Such “ON-OFF” ibrutinib cycles may be repeated until non-tolerability or resistance, or need of continuous dosing of ibrutinib (i.e. early progression when off the drug). If successful, the study will indicate a way forward towards reducing ibrutinib drug costs in health care without affecting long-term disease control, possibly also with fewer ibrutinib-related side effects due to a lower cumulative dose of ibrutinib. Long-term effects on potential mutations within BTK and its downstream signaling molecules will also be analysed. 
Sponsor: Jeanette Lundin 
Intervention: Ibrutinib 
Start Date: 2018-02-23 
Last Updated: 2021-02-25 
Number of Patients: 50 
Recruitment Status: RECRUITING 
Condition: Chronic Lymphocytic Leukemia 

NCTID: NCT01804686

Title: A Long-term Extension Study of PCI-32765 (Ibrutinib) 
Study Summary: The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment. 
Sponsor: Janssen Research & Development, LLC 
Intervention: Ibrutinib 
Start Date: 2013-09-09 
Last Updated: 2023-11-09 
Number of Patients: 700 
Recruitment Status: ENROLLING_BY_INVITATION 
Condition: Chronic Lymphocytic Leukemia 

NCTID: NCT03452319

Title: Effects of Increased Physical Activity Before Thoracoabdominal Esophageal Surgery 
Study Summary: Thoracoabdominal oesophageal resection for cancer is a procedure with high risks for complications, and patients’ preoperative status is a crucial factor for outcome. There are only a few studies that evaluate the effect of preoperative intervention, including physical exercises and breathing exercises, after this type of surgery.  The aim of the study is therefore to evaluate the effect of a training intervention before resection of the oesophagus.  One hundred patients scheduled for oesophagus resection according to Ivor-Lewis from five different hospitals in Sweden will be included. The patients will be randomized to an intervention group or a control group. The training intervention starts directly after preoperative radiotherapy and chemotherapy are given and lasts until three months postoperatively.  Intervention includes increased physical activity, strength training and respiratory muscle training.  At inclusion and three months after discharge, the patients will undergo tests of physical function and lung function. In addition, they will fill in questionnaires concerning level of physical function, level of physical activity and quality of life. These questionnaires will also be answered one year after surgery. 
Sponsor: Göteborg University 
Intervention: Pretraining 
Start Date: 2017-12-01 
Last Updated: 2023-10-02 
Number of Patients: 100 
Recruitment Status: COMPLETED 
Condition: Oesophageal Cancer 

NCTID: NCT00681486

Title: Ghrelin - A Possible Opportunity to Improve Appetite 
Study Summary: The study is designed to evaluate whether ghrelin treatment can improve appetite in weight losing cancer patients. 
Sponsor: Göteborg University 
Intervention: Ghrelin 
Start Date: 2003-10 
Last Updated: 2009-08-21 
Number of Patients: 30 
Recruitment Status: COMPLETED 
Condition: Cancer 

NCTID: NCT00036647

Title: OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer 
Study Summary: The purpose of this study is to determine if OSI-774 will improve overall survival of patients with incurable stage IIIB/IV non-small cell lung cancer compared to standard of care. OSI-774 is a new type of drug under evaluation called an epidermal growth factor receptor (EGFR). OSI-774 is an investigational drug that has not yet been approved by the U.S. Food and Drug Administration (FDA). 
Sponsor: OSI Pharmaceuticals 
Intervention: Tarceva (erlotinib HCl, OSI-774 ) 
Start Date: 2001-11-01 
Last Updated: 2018-01-10 
Number of Patients: 731 
Recruitment Status: COMPLETED 
Condition: Carcinoma, Non-small-cell Lung 

NCTID: NCT04389086

Title: Induction Chemotherapy for Locally Recurrent Rectal Cancer 
Study Summary: This is a multicentre, open-label, parallel arms, phase IIII study that randomises patients with locally recurrent rectal cancer in a 1:1 ratio to receive either induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm) 
Sponsor: Catharina Ziekenhuis Eindhoven 
Intervention: Combination drug 
Start Date: 2020-11-13 
Last Updated: 2022-09-06 
Number of Patients: 364 
Recruitment Status: RECRUITING 
Condition: Recurrent Rectal Cancer 

NCTID: NCT00045019

Title: Study to Assess Cancer Patients’ Satisfaction With Hospital Quality of Care 
Study Summary: RATIONALE: Questionnaires may help determine cancer patients’ satisfaction with the quality of care they received in the hospital.  PURPOSE: Clinical trial to determine the effectiveness of questionnaires in assessing cancer patients’ satisfaction with the quality of care they received in the hospital. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: quality-of-life assessment 
Start Date: 2002-05 
Last Updated: 2012-08-27 
Number of Patients: 795 
Recruitment Status: COMPLETED 
Condition: Unspecified Adult Solid Tumor, Protocol Specific 

NCTID: NCT02385214

Title: MelmarT Melanoma Margins Trial Investigating 1cm v 2cm Wide Excision Margins for Primary Cutaneous Melanoma 
Study Summary: Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with a primary invasive cutaneous melanomas >=1mm thick to determine differences in the rate of local recurrence and melanoma specific survival. A reduction in margins is expected to improve quality of life in patients 
Sponsor: Melanoma and Skin Cancer Trials Limited 
Intervention: Wide Local Excision = 1cm Margin 
Start Date: 2015-01-03 
Last Updated: 2022-04-14 
Number of Patients: 400 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Cutaneous Melanoma by AJCC V7 Stage 

NCTID: NCT03336333

Title: A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL 
Study Summary: To compare efficacy between zanubrutinib versus bendamustine and rituximab in patients with previously untreated CLL/SLL, as measured by progression free survival assess by Independent Central Review. 
Sponsor: BeiGene 
Intervention: Zanubrutinib 
Start Date: 2017-10-31 
Last Updated: 2023-11-09 
Number of Patients: 590 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Chronic Lymphocytic Leukemia 

NCTID: NCT01573247

Title: Safety Study of AKN-028 in Patients With Acute Myelogenous Leukemia 
Study Summary: This Phase 1/2 study consists of two parts. The purpose of Part 1 of the study is to examine the safety and tolerability of AKN-028 and to determine the recommended dose of AKN-028 for further evaluation in Part 2 of the study in patients with Acute Myelogenous Leukemia (AML). The purpose of Part 2 of the study is to determine safety and efficacy in patients with AML. 
Sponsor: Akinion Pharmaceuticals AB 
Intervention: AKN-028 
Start Date: 2011-12 
Last Updated: 2016-03-25 
Number of Patients: 25 
Recruitment Status: TERMINATED 
Condition: Acute Myeloid Leukemia 

NCTID: NCT04571047

Title: Time to Surgery - the Impact of Waiting Time on Outcome After Colorectal Cancer Treatment 
Study Summary: We aim to perform a register-based, observational cohort study to investigate whether it is safe to delay start of treatment with a curative intention after a colorectal cancer diagnosis. Our hypothesis is that delaying start of treatment until 4-8 weeks is as safe as starting treatment within four weeks after a colorectal cancer diagnosis. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Time to treatment 
Start Date: 2020-10-15 
Last Updated: 2021-12-02 
Number of Patients: 40000 
Recruitment Status: COMPLETED 
Condition: Colorectal Cancer 

NCTID: NCT00681187

Title: Somatuline Autogel Preference and Health Economy Study 
Study Summary: The primary aim of this study is to assess which method of lanreotide Autogel administration patients with neuroendocrine tumours prefer - self/partner administrations or healthcare provided administrations. The study will also assess if self/partner administration can be performed without loss of efficacy and with a preserved safety profile. The impact of self/partner administration on resource utilisation and costs will be studied. In addition, we will also assess the healthcare provider’s experience of the two administration practices. 
Sponsor: Ipsen 
Intervention: lanreotide (Autogel formulation) 
Start Date: 2008-06 
Last Updated: 2019-11-22 
Number of Patients: 26 
Recruitment Status: COMPLETED 
Condition: Neuroendocrine Tumour With Carcinoid Symptoms 

NCTID: NCT03898687

Title: The Use of Magtrace®/Sentimag® in Sentinel Node Biopsy for Malignant Melanoma. The Magmen Study. 
Study Summary: To evaluate the use of superparamagnetic iron oxide (Magtrace®) as a tracer in sentinel node biopsy in malignant melanoma of the extremities, and to evaluate the possible role of Magtrace®-MRI for staging.  Primary objective:  • To evaluate if Magtrace®/Sentimag® can be used to identify SN in malignant melanoma with the same diagnostically reliability as the currently used method of Technetium 99m and Patent blue.  Secondary objectives:  • To evaluate if Magtrace®-MRI can predict sentinel node status in melanoma. This is a feasibility phase I, interventional single arm study. All patients included in the study will receive the same management.  20 patients will be included in the study. An enrollment time of 6-12 months is expected.  Primary endpoint • To determine the detection rate of Magtrace®/Sentimag® in comparison to SNB using technetium and blue dye in patients with malignant melanoma of the extremities.  Secondary endpoint  • To evaluate Magtrace®-MRI sensitivity and specificity as a preoperative tool for staging in malignant melanoma. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: SLN Biopsy with Magtrace®/Sentimag® 
Start Date: 2019-03-01 
Last Updated: 2020-10-20 
Number of Patients: 15 
Recruitment Status: COMPLETED 
Condition: Melanoma 

NCTID: NCT05214183

Title: Acalabrutinib and Rituximab in Elderly Patients With Untreated Mantle Cell Lymphoma 
Study Summary: This is a phase II trial, with the aim of developing a chemotherapy-free regimen for untreated patients with mantle cell lymphoma (MCL).  Acalabrutinib (ACP-196) is a next generation bruton tyrosine kinase (BTK) inhibitor, more selective than ibrutinib, and without in vitro antagonism of anti-CD20 directed immunotherapies, indicating that its combination with rituximab may be more active than the combination of ibrutinib and rituximab.  In this trial proposal, we will also assess the activity of this combination in comparison to a historical control of ibrutinib + rituximab, consisting of the experimental arm of ibrutinib + rituximab in the randomized ENRICH trial (EudraCT number 2015-000832-13), and data from our previous trial with R-bendamustine-lenalidomide (NLG-MCL4).  The duration of treatment will be a minimum of 12 months. Patients in molecular remission in blood and bone marrow and in complete remission according to CT, will then stop acalabrutinib, but continue on rituximab for a maximum of 36 months. Patients that are minimal residual disease positive (MRD+) will be evaluated again every 6 months and continue on acalabrutinib for a maximum of 36 months.  Patients without a molecular marker, that cannot be followed with MRD, will stop treatment if in CR with PET at 12 months, and be followed by PET-CT every 6 months for a maximum of 36 months.  Patients who convert back to MRD positive after stopping acalabrutinib are reinstalled on acalabrutinib until progression.  Patients with TP53 aberrations and/or blastoid histology, will monitor MRD but continue with treatment until progression regardless of MRD results.  A planned interim analysis will be performed when 40 patients have undergone response assessment after 6 months, for futility and efficacy.  If less than 16 of 40 patients obtain a CR, the trial will be stopped due to futility. 
Sponsor: Nordic Lymphoma Group 
Intervention: Acalabrutinib-rituximab in patients with untreated mantle cell lymphoma 
Start Date: 2021-12-15 
Last Updated: 2022-02-14 
Number of Patients: 80 
Recruitment Status: RECRUITING 
Condition: MCL 

NCTID: NCT03860883

Title: Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma 
Study Summary: Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life. 
Sponsor: Melanoma and Skin Cancer Trials Limited 
Intervention: Wide Local Excision = 1cm Margin 
Start Date: 2019-12-17 
Last Updated: 2023-10-19 
Number of Patients: 2998 
Recruitment Status: RECRUITING 
Condition: Cutaneous Melanoma, Stage II 

NCTID: NCT01966471

Title: A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer 
Study Summary: This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane. 
Sponsor: Hoffmann-La Roche 
Intervention: Trastuzumab Emtansine 
Start Date: 2014-01-31 
Last Updated: 2022-06-14 
Number of Patients: 1846 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT06104371

Title: Lymph Node Identification Using Magtrace and Magseed Before Chemotherapy 
Study Summary: Magnetic tracer injected before preoperative chemotherapy in breast cancer patients for sentinel lymph node detection. Also, magnetic tracer in combination with magnetic clip for index node identification. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Magtrace 
Start Date: 2023-12-01 
Last Updated: 2023-11-13 
Number of Patients: 459 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT00004179

Title: Combination Chemotherapy With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin’s Lymphoma 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether chemotherapy is more effective with or without rituximab for relapsed non-Hodgkin’s lymphoma.  PURPOSE: This randomized phase III trial is studying combination chemotherapy and rituximab to see how well they work compared to combination chemotherapy alone in treating patients with relapsed non-Hodgkin’s lymphoma. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: rituximab 
Start Date: 1999-05 
Last Updated: 2021-02-15 
Number of Patients: 475 
Recruitment Status: COMPLETED 
Condition: Lymphoma 

NCTID: NCT00006479

Title: Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with surgery may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for liver metastases.  PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have liver metastases from colorectal cancer. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: FOLFOX regimen 
Start Date: 2000-09 
Last Updated: 2011-04-18 
Number of Patients: NA 
Recruitment Status: UNKNOWN 
Condition: Colorectal Cancer 

NCTID: NCT05748171

Title: A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL 
Study Summary: This prospective, randomized, multicenter, open-label Phase 2 study is designed to evaluate the superiority of InO monotherapy vs ALLR3 after 1 cycle of induction treatment in paediatric participants (between 1 and <18 years) with High Risk (HR) first bone marrow relapse CD22-positive BCP ALL, and to evaluate the safety and tolerability, PK and long-term efficacy. Treatment with study intervention will end after induction therapy; follow-up will continue for up to 5 years from randomization. 
Sponsor: Pfizer 
Intervention: Inotuzumab ozogamicin 
Start Date: 2023-05-17 
Last Updated: 2023-11-14 
Number of Patients: 100 
Recruitment Status: RECRUITING 
Condition: ACUTE LYMPHOBLASTIC LEUKEMIA 

NCTID: NCT00066703

Title: Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer 
Study Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer.  PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer. 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: exemestane 
Start Date: 2003-11-03 
Last Updated: 2022-11-17 
Number of Patients: 2672 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT02807454

Title: A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma 
Study Summary: This is an open-label, multicenter study to confirm the safety and efficacy of durvalumab + daratumumab (D2) in subjects with relapsed and refractory multiple myeloma. This study will also explore the safety and efficacy of the addition of pomalidomide + dexamethasone to durvalumab + daratumumab (PD3).  On 05 Sep 2017, a Partial Clinical Hold was placed on this study by the United States (US) Food and Drug Administration (FDA). The decision by the FDA was based on data related to risks of anti-programmed cell death-1 (PD-1) antibody, pembrolizumab, in combination with IMiDs® immunomodulatory drugs in patients with multiple myeloma. As a result, enrollment into this study has been discontinued. Subjects who are receiving clinical benefit, based on the discretion of the investigator, may remain on study treatment after being reconsented. 
Sponsor: Celgene 
Intervention: Daratumumab 
Start Date: 2016-07-07 
Last Updated: 2023-02-21 
Number of Patients: 37 
Recruitment Status: TERMINATED 
Condition: Multiple Myeloma 

NCTID: NCT05257083

Title: A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma 
Study Summary: The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in newly diagnosed multiple myeloma patients. 
Sponsor: European Myeloma Network 
Intervention: Daratumumab 
Start Date: 2023-10-10 
Last Updated: 2023-11-18 
Number of Patients: 750 
Recruitment Status: RECRUITING 
Condition: Multiple Myeloma 

NCTID: NCT00382031

Title: Zalutumumab in Patients With Non-curable Head and Neck Cancer 
Study Summary: The purpose of this study is to investigate if zalutumumab in combination with Best Supportive Care (BSC) is superior to BSC in non-curable patients with head and neck cancer 
Sponsor: Genmab 
Intervention: Zalutumumab 
Start Date: 2006-11 
Last Updated: 2013-10-15 
Number of Patients: 286 
Recruitment Status: COMPLETED 
Condition: Head and Neck Cancer 

NCTID: NCT03045965

Title: Hysterectomy and OPPortunistic SAlpingectomy 
Study Summary: HOPPSA is a register based randomized controlled trial (R-RCT), with the objective to examine if opportunistic salpingectomy compared with no salpingectomy, at the time of hysterectomy for a benign reason  * has no increased risk of complications * has no negative side effects on ovarian function and subsequent cardiovascular disease or incidence of fractures * implies reduced risk of subsequent ovarian cancer Randomization and follow-up will be conducted within national registers. 
Sponsor: Göteborg University 
Intervention: Salpingectomy 
Start Date: 2017-06-01 
Last Updated: 2023-04-04 
Number of Patients: 4400 
Recruitment Status: RECRUITING 
Condition: Ovarian Cancer 

NCTID: NCT01694238

Title: A Randomized Trial on the Technical Aspects of Stoma Construction. 
Study Summary: An investigation on the difference in stoma hernia frequency related to surgical technique when incising the fascia. All patients planned for elective colostomy formation are to be included. Patients undergoing rectal resection with a TME and a colostomy (Hartmann’s procedure) for rectal cancer, abdominoperineal resection for rectal cancer or diverting colostomy for any reason are all included.  The three groups for randomization are:  A. circular incision in the abdominal wall fascia B. cruciate incision in the abdominal wall fascia C. mesh enforced cruciate incision in the abdominal wall fascia Primary endpoint is the parastomal hernia rate within 12 months from index surgery. Secondary end-points include clinical variables, re-admission and/or re-operation due to any stoma complication, quality of life and health economy analyses, at 12 months. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Cruciate incision 
Start Date: 2013-06 
Last Updated: 2019-03-29 
Number of Patients: 209 
Recruitment Status: COMPLETED 
Condition: Colostomy 

NCTID: NCT02240472

Title: Sentinel Node Biopsy in Breast Cancer: Omission of Axillary Clearance After Macrometastases. A Randomized Trial. 
Study Summary: Since the introduction of sentinel node biopsy in breast cancer, it has become clear that its use is reliable and reproducible. Today, it is clinical routine to not remove further lymph nodes from the axilla (arm pit) in case the sentinel node (which is the first lymph node/s reached by lymphatic flow from the breast) is free of tumor deposits. It is also routine to leave remaining lymph nodes behind in case the sentinel node contains a minimal cluster of tumor cells, called isolated tumor cells (formerly submicrometastasis). Even in slightly larger tumor deposits, so called micrometastasis (up to 2 mm in size), it has been shown that a completion axillary clearance (removal of further lymph nodes from the arm pit) does not contribute to a better survival. Data from a randomized study indicate that it seems safe to omit axillary clearance even if the sentinel node biopsy shows up to 2 nodes with tumor deposits over 2 mm in size (macrometastasis). These studies have changed clinical practice in many countries, however, it is still debated whether it is safe to omit axillary clearance in the case of sentinel node macrometastasis due to under-recruitment in the aforementioned study. The rationale for omitting extensive axillary surgery is the avoidance of postoperative morbidity such as arm lymphedema, loss of sensation, pain and swelling.  The hypothesis is that refraining from axillary clearance in breast cancer patients with 1-2 sentinel nodes with macrometastasis will not worsen breast cancer-specific survival by more than a maximum of 2.5% after 5 years.  This study is a prospective international randomized trial including 3500 patients.  Breast cancer patients without signs of axillary nodal involvement will be eligible for sentinel node biopsy. Those who are found to have up to two sentinel node containing macrometastasis will be informed about this trial Those wishing to participate will be randomized to either undergo further axillary surgery (clearance) or not. Outcome measures are breast cancer-specific survival, disease-free survival, axillary recurrence rate and overall survival. 
Sponsor: Karolinska Institutet 
Intervention: Omission of axillary clearance 
Start Date: 2015-01-27 
Last Updated: 2023-10-06 
Number of Patients: 2700 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT05477589

Title: Studying Conditioning Regimen In Pediatric Transplantation - AML , SCRIPT-AML 
Study Summary: It is a randomized phase 3 study comparing two conditioning regimens in children with Acute Myeloid Leukemia, AML, undergoing allogenic stem cell transplantation. The primary aim is to investigate if a conditioning regimen containing one alkylator (Bu) combined with two antimetabolites (Clo and Flu) results in superior 2-year acute grade III to IV-free, chronic non-limited GvHD-free, relapse free survival than a conditioning regimen combining three alkylating agents (BuCyMel) 
Sponsor: Vastra Gotaland Region 
Intervention: busulfan, cyclophosphamide and melphalan, BuCyMel 
Start Date: 2022-06-07 
Last Updated: 2022-12-19 
Number of Patients: 170 
Recruitment Status: RECRUITING 
Condition: Acute Myeloid Leukemia (AML) in Remission 

NCTID: NCT04705389

Title: SerUM Markers in MERkel Cell Carcinoma Patients: a Longitudinal moniTorIng Study for optiMization of European Guidelines 
Study Summary: Merkel cell carcinoma (MCC) is a rare aggressive skin carcinoma. Approximately 80% of MCC are related to the Merkel Cell Polyomavirus (MCPyV). Although rates of relapse are high, the follow-up strategy lacks consensus. Patients are usually assessed clinically every 3 to 6 months for the first 2-3 years, and every 6 to 12 months thereafter. In the European guidelines, patients with early stages are monitored with clinical examination and ultrasonography of lymph nodes, while whole-body imaging is optional in patients with stage III disease, on a yearly basis for 5 years. Such strategy may prevent the diagnosis of infra-clinical recurrences, whereas patients could still be treated with surgery or radiation therapy. Until 2017, patients with advanced disease were treated with chemotherapies, with no long-term benefit. Immunotherapies with PD-1/PD-L1 inhibitors currently allow durable responses in 50% of such patients. This major change in the management of MCC patients argues for a follow-up strategy that would allow early diagnosis of infra-clinical metastases, when tumoral burden is still low. Given that all patients cannot be monitored by systematic regular imaging, additional non-invasive tools are needed. Blood-based biomarkers as a surrogate of tumor burden are advantageous as they can be repeated over time, providing guidance on when imaging is necessary. The study aims to assess two blood biomarkers, MCPyV T-Ag antibodies and cell-free miR-375, in a prospective fashion from baseline diagnosis, in a cohort of 150 European MCC patients 
Sponsor: University Hospital, Tours 
Intervention: Samples 
Start Date: 2021-09 
Last Updated: 2021-05-18 
Number of Patients: 150 
Recruitment Status: UNKNOWN 
Condition: Merkel Cell Carcinoma 

NCTID: NCT02644187

Title: Pain Relief During Photodynamic Therapy for Actinic Keratoses With a New Irradiation Protocol 
Study Summary: This pilot study will try to minimize the pain during exposure to a new red light source (RhodoLED®, Biofrontera Bioscience GmbH, Leverkusen, Germany) used for PDT without compromising its effect on AKs.  The study design will have an open and prospective, two-armed, split-face design. Participants with AK lesions distributed symmetrically on the scalp, forehead, cheeks, torso, back, arms and/or dorsal parts of the hands are eligible for inclusion. The purpose is to investigate if a modified irradiation protocol can lower the pain while having the same effect on AK clearance rates as compared to the standard PDT irradiation protocol.  Before any study-related procedures are performed, the participants will be thoroughly informed about the study and will be given the opportunity to ask questions. The participants will thereafter sign and date the informed consent form. This constitutes as visit 0.  On visit 1, a randomization to either the standard or the modified irradiation protocol will be performed on one side of the face/body and the other irradiation protocol will then be applied on the other side of the face/body. The participants should have AKs on two comparable sites, i.e. two cheeks, arms or dorsal parts of the hands. One side will be randomized to receive PDT with BF200-ALA and irradiation with the RhodoLED® lamp and the other side will receive BF200-ALA and the Aktilite CL-128 lamp (PhotoCure ASA, Oslo, Norway), which is the traditional lamp used at our department as mentioned above.  The treatment will be given at visit 1. During the treatment, the participants will be asked continuously, every third minute, to estimate the pain on each treatment side using the visual analogue scale, VAS, (where 0 is no pain and 10 is the worst pain imaginable). At the end of the treatment, the participants will also be asked to summarize the treatment as a whole on the VAS-scale. After visit 1, the participants will fill in a follow-up diary form with questions regarding adverse effects (AEs) during the hours and days after the treatment. The efficacy of the treatment will also be assessed at a follow-up (FU) visit, visit 2. The investigators are aiming for a non-inferior analysis, i.e. the new modified irradiation protocol should be at least as good as the standard irradiation protocol. The randomization is blinded for the investigator at the FU visit to minimize the possibility of favoring one irradiation protocol. 
Sponsor: Vastra Gotaland Region 
Intervention: BF-RhodoLED 
Start Date: 2015-12 
Last Updated: 2017-05-10 
Number of Patients: 30 
Recruitment Status: COMPLETED 
Condition: Therapy, Photodynamic 

NCTID: NCT03285763

Title: A Study of Atezolizumab (Tecentriq) to Investigate Long-term Safety and Efficacy in Previously-treated Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) 
Study Summary: This is a Phase III/IV, single-arm, multicenter study of the long-term safety and efficacy of atezolizumab treatment in participants with Stage IIIb or Stage IV NSCLC who have progressed after standard systemic chemotherapy (including if given in combination with anti-programmed cell death protein 1 <math display="block">anti-PD-1</math> therapy, after anti-PD-1 as monotherapy, or after tyrosine kinase inhibitor <math display="block">TKI</math> therapy). The study will consist of a Screening Period, a Treatment Period, a Treatment Discontinuation Visit, and a Follow-Up Period. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2017-10-25 
Last Updated: 2022-05-26 
Number of Patients: 619 
Recruitment Status: COMPLETED 
Condition: Carcinoma, Non-Small-Cell Lung 

NCTID: NCT05184582

Title: Physical Exercise During Preoperative Chemotherapy for Breast Cancer 
Study Summary: Neoadjuvant chemotherapy (NACT) is increasingly used in breast cancer. The best proof of NACT efficacy is pathological complete response (pCR), i.e. the absence of invasive tumour on post-NACT surgical histopathology. While it is known that physical exercise can help patients to better tolerate and complete often harsh cancer treatments, it is an emerging area of research to understand if and how exercise exerts anti-tumour effects and improves oncological outcomes.  The main aim of the Neo-ACT trial is to examine if a physical exercise intervention during NACT can increase pCR rates in breast cancer. Secondary aims are residual cancer burden, radiological tumour response, patient-related outcomes (health-related quality of life, physical activity), physiological outcomes (muscle strength, cardiorespiratory fitness), cancer treatment-related toxicities (cognitive dysfunction, chemotherapy completion rates) and long-term sick leave. Furthermore, the trial will explore how physical exercise affects anti-tumoral mechanisms inherent to therapy or host by hypothesis-generating translational analyses.  712 patients with primary invasive breast cancer will be randomized to either a supervised intervention of high-intensity interval and resistance training during NACT, supported by an exercise app, or to usual care, and followed for two years. Physical activity is meticulously tracked. By offering patients active involvement, the trial contributes strongly to the concept of personalized medicine. 
Sponsor: Karolinska Institutet 
Intervention: Physical training 
Start Date: 2022-11-09 
Last Updated: 2023-01-30 
Number of Patients: 712 
Recruitment Status: RECRUITING 
Condition: Breast Cancer 

NCTID: NCT01569282

Title: Double Bypass Versus Stent-treatment in Irresectable Pancreatic Cancer 
Study Summary: Double bypass (hepaticojejunostomy + gastrojejunostomy) is compared to stent strategy in patients planned for curative pancreatic resection in whom peroperative findings makes resection impossible. 
Sponsor: Göteborg University 
Intervention: Hepaticojejunostomy and gastroenterostomy 
Start Date: 2011-10 
Last Updated: 2019-03-22 
Number of Patients: 0 
Recruitment Status: WITHDRAWN 
Condition: Pancreatic Cancer 

NCTID: NCT00342316

Title: Reduced Intensity Conditioning Transplantation Versus Standard of Care in Acute Myeloid Leukemia 
Study Summary: This study compares overall survival between patients with acute myeloid leukemia, who are in complete remission following initial treatment with chemotherapy and whose remission is maintained either with a transplantation of stem cells obtained from a sibling or unrelated donor or with standard treatment, which is additional chemotherapy.  The study hypothesis is that the group transplanted with stem cells from a donor will have a superior survival compared with patients treated with standard of care. 
Sponsor: Vastra Gotaland Region 
Intervention: Reduced Intensity Conditioning Stem Cell Transplantation 
Start Date: 2003-12-18 
Last Updated: 2020-01-27 
Number of Patients: 340 
Recruitment Status: COMPLETED 
Condition: Acute Myeloid Leukemia 

NCTID: NCT01664663

Title: Phase II Randomized Study on Locally Advanced NSCLC Escalated Dose on Individual Basis Treatment With Radiochemotherapy 
Study Summary: The purpose of this study is to examine the valu of individually dose escalated radiotherapy compared with a standard dose of radiotherapy combined with standard concomitant chemotherapy for patients with locally advanced non small cell lung cancer (stage III) with good performance status. 
Sponsor: Ass. Prof. Jan Nyman 
Intervention: Standard radiochemotherapy to 68 Gy 
Start Date: 2011-09 
Last Updated: 2014-12-09 
Number of Patients: 37 
Recruitment Status: TERMINATED 
Condition: Non Small Cell Lung Cancer 

NCTID: NCT02530593

Title: QoLiCOL - Quality of Life in Colon Cancer 
Study Summary: All patients presenting at participating hospitals during the recruitment period with a newly diagnosed colon cancer, regardless of stage and planned treatment, will be eligible for inclusion. They will answer a questionnaire on health related quality of life, physical symptoms, functional impairments and socioeconomic status at diagnosis and after 12, 36 months. Clinical data including recurrence, survival, surgical treatment, oncologic result (pathology report) and adjuvant treatment will be collected from the Swedish ColoRectal Cancer Registry (SCRCR) 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: There is no intervention, only observation 
Start Date: 2015-06 
Last Updated: 2023-11-07 
Number of Patients: 1500 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Colonic Neoplasm 

NCTID: NCT02239120

Title: Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS) 
Study Summary: This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment). 
Sponsor: Boehringer Ingelheim 
Intervention: optional ASA as comedication 
Start Date: 2014-11-27 
Last Updated: 2019-09-06 
Number of Patients: 5390 
Recruitment Status: COMPLETED 
Condition: Stroke 

NCTID: NCT00560482

Title: Efficacy Study of ABR-215050 to Treat Prostate Cancer 
Study Summary: To investigate ABR-215050 as a possible treatment for prostate cancer. 
Sponsor: Active Biotech AB 
Intervention: ABR-215050, tasquinimod 
Start Date: 2007-12 
Last Updated: 2015-10-26 
Number of Patients: 206 
Recruitment Status: COMPLETED 
Condition: Prostate Cancer 

NCTID: NCT01785316

Title: The Scandinavian Randomized Controlled Trial of Isolated Hepatic Perfusion for Uveal Melanoma Liver Metastases 
Study Summary: A randomized controlled, open-label, multi-centre study evaluating if Isolated Hepatic Perfusion (IHP) increases Overall Survival compared with Best Alternative Care (BAC) in patients with isolated liver metastases from uveal melanoma. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: IHP 
Start Date: 2013-06-15 
Last Updated: 2023-04-05 
Number of Patients: 93 
Recruitment Status: COMPLETED 
Condition: Melanoma 

NCTID: NCT05119582

Title: HIFU Treatment of Cutaneous Neurofibromas in Neurofibromatosis Type 1: Safety and Efficacy 
Study Summary: The overall objective is to demonstrate safety and efficacy of HIFU treatment of cutaneous neurofibromas located close to the surface of the skin in patients with the genetic disease Neurofibromatosis Type 1. The study will use a new investigational equipment that has been specially developed for dermatological therapy.  The study includes 20 patients in total distributed between the two centers, each having a minimum of 8 cutaneous neurofibromas eligible for treatment. All participants are adults (over 18 years) of both sexes.  The new treatment method is based on focusing intensive ultrasound just below the skin surface. This creates a very fast localized heating in small and very well-defined volumes containing neurofibroma tissue. This heating destroys or weakens the tissue, and the body’s natural processes will subsequently transport affected cells away through the lymphatic and vascular systems. During the healing-process, the rejected tissue is replaced by new skin cells that are not expected to be fibrous.  The treatment is intended to be carried out without breaking the skin surface, and open wounds are therefore avoided. This is an essential advantage of the method compared to all existing therapies, which are based on physical removal of tumors through an open skin surface (e.g. surgery or laser therapy). Complications with risk of pain, infection and scarring will therefore be significantly reduced with the new proposed method.  The treatment is carried out by sending focused ultrasound from the handpiece of the equipment into the target area with neurofibromas. The equipment is set to send doses of approximately 150 milliseconds (0.15 seconds). The skin area and HIFU doses can be followed on the system computer screen and will be placed side-by-side with approximately 1-2 millimeter spacing. To achieve good energy transfer from handpiece to skin, ordinary ultrasound gel is used. There are no other special pre-treatments or preparations for the process. HIFU treatment is expected to be less painful than other treatments used. The treatment is quick, and typically takes less than 1 minute for a each area the size of a typical neurofibroma. 
Sponsor: Joergen Serup 
Intervention: TOOsonix System ONE-M 
Start Date: 2022-04-13 
Last Updated: 2023-08-28 
Number of Patients: 20 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Cutaneous Neurofibroma 

NCTID: NCT05789082

Title: A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation 
Study Summary: The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of divarasib combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC). 
Sponsor: Hoffmann-La Roche 
Intervention: Divarasib 
Start Date: 2023-06-20 
Last Updated: 2023-11-13 
Number of Patients: 60 
Recruitment Status: RECRUITING 
Condition: Non-Small Cell Lung Cancer 

NCTID: NCT03540420

Title: Atezolizumab After Concurrent Chemo-radiotherapy Versus Chemo-radiotherapy Alone in Limited Disease Small-cell Lung Cancer 
Study Summary: Some patients with limited disease small-cell lung cancer (LD SCLC) are cured after chemo-radiotherapy, but the majority relapse and die from their cancer. Better therapy is needed. Immunotherapy represents the largest advance in cancer therapy in recent years and has demonstrated promising activity in SCLC. In this study we will investigate whether atezolizumab prolongs survival in LD SCLC patients who have undergone chemo-radiotherapy. 
Sponsor: Norwegian University of Science and Technology 
Intervention: Atezolizumab 
Start Date: 2018-07-31 
Last Updated: 2023-05-06 
Number of Patients: 212 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Small-cell Lung Cancer 

NCTID: NCT04463368

Title: Isolated Hepatic Perfusion in Combination With Ipilimumab and Nivolumab in Patients With Uveal Melanoma Metastases 
Study Summary: Uveal melanoma is the most common primary intraocular malignancy in adults. Despite successful control of the primary tumour, metastatic disease will develop in approximately 35%-50% of the patients within 10 years. The liver is the most common site for metastases, and about 50% of the patients will have isolated liver metastases. Isolated hepatic perfusion is a regional treatment where the liver is completely isolated from the systemic circulation, allowing a high concentration of chemotherapy to be perfused through the liver with minimal systemic exposure. The introduction of modern immunotherapy in the treatment arsenal for cutaneous melanoma also creates hope for patients with uveal melanoma metastases. However, the results of immunotherapy have so far been disappointing. The reason for the low efficacy could be that uveal melanoma develops in the immune privileged eye.  The hypothesis in this trial is that isolated hepatic perfusion with melphalan causes an immunogenic type of cell death by local tumour destruction while leaving the immune-system intact. This will cause an activation of the immune-system and the addition of ipilimumab and nivolumab will enhance this effect, ultimately increasing the treatment efficacy.  The primary objective of this trial is to evaluate the safety and tolerability of isolated hepatic perfusion together with ipilimumab and nivolumab when given at the same time or as a sequenced regimen. The study design is a phase I randomized controlled, multicentre, open-label trial. Active follow-up will be performed for 2 years. Patients will be randomized after diagnoses of metastatic disease to one of the following treatment arms:  Arm A. Patients will be treated with IHP followed by 4 courses of ipilimumab 3mg/kg and nivolumab 1mg/kg every third week followed by continued nivolumab 480mg q4w up to 1 year.  Arm B. Patients will be treated with 1 course of ipilimumab 3mg/kg and nivolumab 1mg/kg followed by IHP after 3 weeks and then another 3 courses of ipilimumab 3mg/kg and nivolumab 1mg/kg every third week followed by continued nivolumab 480mg q4w up to 1 year. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Isolated hepatic perfusion 
Start Date: 2021-03-08 
Last Updated: 2023-11-22 
Number of Patients: 18 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Uveal Melanoma 

NCTID: NCT01332968

Title: A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin’s Lymphoma (GALLIUM) 
Study Summary: This open-label, randomized study will assess the efficacy and safety of obinutuzumab (RO5072759) in combination with chemotherapy compared to rituximab (MabThera/Rituxan) with chemotherapy followed by obinutuzumab or rituximab maintenance in participants with untreated advanced indolent non-Hodgkin’s lymphoma. After the end of the induction period, participants achieving response (Complete response <math display="block">CR</math> or partial response <math display="block">PR</math>) will undergo a maintenance period continuing on the randomized antibody treatment alone every 2 months until disease progression for a total of 2 years. Anticipated time on study treatment is up to approximately 2.5 years. After maintenance or observation, participants will be followed for 5 years until progression. After progression, participants will be followed for new anti-lymphoma therapy and overall survival until the end of the study. 
Sponsor: Hoffmann-La Roche 
Intervention: Obinutuzumab 
Start Date: 2011-07-06 
Last Updated: 2022-08-11 
Number of Patients: 1401 
Recruitment Status: COMPLETED 
Condition: Non-Hodgkin’s Lymphoma 

NCTID: NCT03322215

Title: HR+/HER2- Advanced Breast Cancer and Endocrine Resistance 
Study Summary: This is a randomized, 2-arm, open-label, multicenter, international phase II trial. A total of 196 patients will be included.  The study will include patients with metastatic Hormone Receptor positive / Human Epidermal Growth Factor Receptor (HER2) negative breast cancer with progressive disease after endocrine treatment.  Patients will be randomized (1:1) between two treatment arms: A. palbociclib + fulvestrant and b. capecitabine. 
Sponsor: Theodoros Foukakis 
Intervention: Palbociclib 
Start Date: 2017-10-24 
Last Updated: 2023-05-23 
Number of Patients: 42 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer Metastatic 

NCTID: NCT04920149

Title: Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome 
Study Summary: Multicenter, multinational, randomized, 2-arm, double-blind, phase II clinical study with 2000mg mesalamine, or placebo for prevention of colorectal neoplasia in Lynch Syndrome patients during and following daily intake for 2 years. 
Sponsor: Ann-Sofie Backman 
Intervention: Mesalamine 
Start Date: 2022-03-21 
Last Updated: 2022-03-28 
Number of Patients: 260 
Recruitment Status: RECRUITING 
Condition: Lynch Syndrome 

NCTID: NCT03138226

Title: Living Donor Uterus Transplantation Between Identical Twins 
Study Summary: Living donor uterus transplantation between identical twins, with IVF before and ET several months after transplantation. The donor should have completed childbirth. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: uterus transplantation 
Start Date: 2017-01-01 
Last Updated: 2021-12-15 
Number of Patients: 1 
Recruitment Status: COMPLETED 
Condition: Absolute Uterine Factor Infertility 

NCTID: NCT01307605

Title: Rituximab With or Without Lenalidomide in Treating Patients With Previously Untreated Follicular Lymphoma 
Study Summary: RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Lenalidomide may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer. It is not yet known whether rituximab is more effective when given alone or together with lenalidomide in treating patients with follicular lymphoma.  PURPOSE: This randomized phase II trial is studying rituximab to see how well it works compared with giving rituximab together with lenalidomide in treating patients with previously untreated follicular lymphoma. 
Sponsor: Swiss Group for Clinical Cancer Research 
Intervention: Rituximab 
Start Date: 2011-02-09 
Last Updated: 2023-06-27 
Number of Patients: 154 
Recruitment Status: TERMINATED 
Condition: Lymphoma 

NCTID: NCT01397305

Title: An Extended Feasibility Phase I/II Study of Methylenetetrahydrofolate (Arfolitixorin) and Pemetrexed Single Agent, Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer 
Study Summary: The purpose of this study is to determine whether an optimal dose of <math display="block">6R</math> 5,10-methylenetetrahydrofolate (arfolitixorin) in combination with pemetrexed are effective in pre-operative treatment of patients with resectable rectal cancer. 
Sponsor: Isofol Medical AB 
Intervention: [6R] 5,10-methylenetetrahydrofolate (arfolitixorin) 
Start Date: 2011-04-14 
Last Updated: 2020-09-09 
Number of Patients: 24 
Recruitment Status: COMPLETED 
Condition: Rectal Cancer 

NCTID: NCT04006405

Title: AURORAX-0087A: GAG Scores for Surveillance of Recurrence in Leibovich Points ≥5 Non-metastatic ccRCC 
Study Summary: AUR87A is an observational prospective multicenter diagnostics test cohort study for detection of renal cell carcinoma recurrence as determined by the reference standard, which is imaging using computed tomography (CT) of the chest and abdomen at defined intervals after primary surgery. 
Sponsor: Elypta 
Intervention: GAG score 
Start Date: 2020-01-10 
Last Updated: 2023-05-11 
Number of Patients: 280 
Recruitment Status: RECRUITING 
Condition: Clear Cell Renal Cell Carcinoma 

NCTID: NCT04534205

Title: A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1 
Study Summary: An open-label, controlled, multi-site, interventional, 2-arm, Phase II trial of BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as first line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing programmed cell death ligand -1 (PD-L1) with combined positive score (CPS) ≥1.  This trial has two parts.  Part A, an initial non-randomized Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab.  Part B, the Randomized part of the trial to generate pivotal efficacy and safety data of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy in the first line setting in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1.  For Part B, an optional pre-screening phase is available for all patients where patients’ tumor samples may be submitted for central HPV16 DNA and central PD-L1 expression testing prior to screening into the main trial. 
Sponsor: BioNTech SE 
Intervention: BNT113 
Start Date: 2021-01-07 
Last Updated: 2023-11-15 
Number of Patients: 285 
Recruitment Status: RECRUITING 
Condition: Unresectable Head and Neck Squamous Cell Carcinoma 

NCTID: NCT01918527

Title: Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer 
Study Summary: The purpose of this study is to compare 3 cycles of neoadjuvant (preoperative) chemotherapy + operation with the standard treatment of locally advanced colon cancer, which is operation + 8 cycles of (adjuvant) chemotherapy.  Patients receiving neoadjuvant chemotherapy may not need adjuvant chemotherapy after the operation and, if this is the case, they will be spared of 5 cycles of chemotherapy. 
Sponsor: Vejle Hospital 
Intervention: Capecitabine 
Start Date: 2013-09 
Last Updated: 2023-10-06 
Number of Patients: 250 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Colon Cancer 

NCTID: NCT03073304

Title: A Randomized Controlled Study Comparing Priming Solution Containing Crystalloid or Packed Red Blood Cells in Patients Treated With Isolated Limb Perfusion. 
Study Summary: The primary aim of this study is to investigate the possibility to replace an erythrocyte based prime solution with a crystalloid based prime solution while maintaining metabolic function. Secondary also to study if potentially reduced immunological influence is obtained during hyper thermic isolated limb perfusion with a crystalloid based prime solution. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Crystalloid based prime solution 
Start Date: 2017-02-24 
Last Updated: 2018-04-20 
Number of Patients: 18 
Recruitment Status: COMPLETED 
Condition: Melanoma 

NCTID: NCT00043004

Title: Chemotherapy and Bevacizumab With or Without Radiofrequency Ablation in Treating Unresectable Liver Metastases in Patients With Colorectal Cancer 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread by blocking blood flow. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiofrequency ablation uses high-frequency electric current to kill tumor cells. It is not yet known if chemotherapy is more effective with or without radiofrequency ablation in treating liver metastases.  PURPOSE: This randomized phase II trial is studying combination chemotherapy, bevacizumab, and radiofrequency ablation to see how well they work compared to combination chemotherapy and bevacizumab alone in treating unresectable liver metastases in patients with colorectal cancer. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: bevacizumab 
Start Date: 2002-05 
Last Updated: 2012-09-24 
Number of Patients: 119 
Recruitment Status: TERMINATED 
Condition: Colorectal Cancer 

NCTID: NCT00943826

Title: A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma 
Study Summary: This 2 arm study investigated the efficacy and safety of the addition of bevacizumab to the current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide) as compared to the current standard of care alone. Participants were randomly assigned to either the bevacizumab (10 milligrams per kilogram (mg/kg) intravenously <math display="block">IV</math> once every 2 week <math display="block">q2w</math>) or the placebo arm, in combination with radiation therapy (total dose 60 Gray <math display="block">Gy</math>, administered as 2 Gy fractions, 5 days/week) plus temozolomide (75 milligrams per meter squared <math display="block">mg/m\^2</math> oral administration <math display="block">po</math> daily) for 6 weeks. After a 4 week treatment break, participants continued to receive bevacizumab (10 mg/kg IV q2w) or placebo, plus temozolomide (150-200 mg/m^2 po daily on days 1-5 of each 4 week cycle) for 6 cycles of maintenance treatment or until disease progression or unacceptable toxicity, whichever occured first. Following the maintenance phase, bevacizumab (15 mg/kg iv every 3 weeks <math display="block">q3w</math>) or placebo monotherapy continued. The time on study treatment was until disease progression. 
Sponsor: Hoffmann-La Roche 
Intervention: Bevacizumab 
Start Date: 2009-06-29 
Last Updated: 2017-09-25 
Number of Patients: 921 
Recruitment Status: COMPLETED 
Condition: Glioblastoma 

NCTID: NCT04464226

Title: Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer 
Study Summary: The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor’s visits as often as they did in the previous study. 
Sponsor: Bayer 
Intervention: Darolutamide (Nubeqa, BAY1841788) 
Start Date: 2020-10-20 
Last Updated: 2023-11-18 
Number of Patients: 678 
Recruitment Status: RECRUITING 
Condition: Cancer 

NCTID: NCT04243005

Title: Supramarginal Resection in Glioblastoma 
Study Summary: Gliomas are the most common malignant brain tumor. Glioblastoma, WHO grade IV astrocytoma, is the most common subtype and unfortunately also the most aggressive subtype with median survival in population based cohorts being only 10 months. Extensive surgical resections followed by postoperative fractioned radiotherapy and concomitant and adjuvant temozolomide prolong survival and is the standard treatment.  The investigators think there is significant potential in individualized surgical decision-making in glioblastoma management. The idea that some patients are amendable to radical surgery, while others should be treated more conservatively, is not controversial in other fields of oncology. The current concept in all patients with glioblastoma is “maximum safe resection of the contrast enhancing tumor”, but this may in selected cases be extended to simply “maximum safe resection” tailored to the patient and extent of disease at hand.  Densely proliferating tumor cells have been found from at an average of 10 mm beyond the margins of contrast enhancement in high-grade gliomas. There are now several case series, using various definitions of supramarginal resection, but they have in common that they report a benefit of resection with a margin. This potential benefit also comes together with an associated neurological risk, making this approach unethical and simply not feasible in the patients with glioblastoma as a whole.  Objective of this study is: To investigate if resection with a margin, that is significantly beyond the radiological contrast enhancement, improves survival in selected patients with glioblastoma. 
Sponsor: St. Olavs Hospital 
Intervention: Supramarginal resection 
Start Date: 2020-07-01 
Last Updated: 2022-12-09 
Number of Patients: 90 
Recruitment Status: RECRUITING 
Condition: Glioblastoma 

NCTID: NCT00297791

Title: COLOR II: Laparoscopic Versus Open Rectal Cancer Removal 
Study Summary: COLOR II is a randomized, international, multi center study comparing the outcomes of laparoscopic and conventional resection of rectal carcinoma below 15 cm with curative intent. Clinical and operative data will be collected centrally in the coordinating centre in Halifax, Canada. Quality of life and costs will be assessed on a national basis. 
Sponsor: Jaap Bonjer 
Intervention: surgery 
Start Date: 2004-06 
Last Updated: 2013-07-30 
Number of Patients: 1100 
Recruitment Status: UNKNOWN 
Condition: Rectal Cancer 

NCTID: NCT00003991

Title: Interleukin-2 Plus Histamine Dihydrochloride in Treating Patients With Acute Myeloid Leukemia 
Study Summary: RATIONALE: Interleukin-2 may stimulate a person’s white blood cells to kill acute myeloid leukemia cells. Histamine dihydrochloride may prolong remission and reduce the risk of relapse in patients with acute myeloid leukemia in remission.  PURPOSE: Randomized phase III trial to determine the effectiveness of interleukin-2 plus histamine dihydrochloride in treating patients who have acute myeloid leukemia that is in remission following previous therapy. 
Sponsor: Maxim Pharmaceuticals 
Intervention: aldesleukin 
Start Date: 1998-07 
Last Updated: 2013-11-06 
Number of Patients: 360 
Recruitment Status: COMPLETED 
Condition: Leukemia 

NCTID: NCT02008227

Title: A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy 
Study Summary: This global, multicenter, open-label, randomized, controlled study evaluated the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 <math display="block">anti-PD-L1</math> antibody)compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as participants experienced clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression. 
Sponsor: Hoffmann-La Roche 
Intervention: Atezolizumab 
Start Date: 2014-03-11 
Last Updated: 2019-12-20 
Number of Patients: 1225 
Recruitment Status: COMPLETED 
Condition: Non-Squamous Non-Small Cell Lung Cancer 

NCTID: NCT04914026

Title: MicroRNA as Markers in Testicular Cancer 
Study Summary: The main objective of this study is establish the performance of miR371 in management of testicular cancer 
Sponsor: Haukeland University Hospital 
Intervention: Biomarker analysis 
Start Date: 2016-12-31 
Last Updated: 2022-08-08 
Number of Patients: 350 
Recruitment Status: RECRUITING 
Condition: Testicular Germ Cell Cancer 

NCTID: NCT00020826

Title: Assessing Quality of Life of Patients With Stomach Cancer 
Study Summary: RATIONALE: Assessing quality of life in patients who are undergoing cancer treatment may help determine the effect of treatment on these patients.  PURPOSE: Clinical trial to study the effectiveness of a quality of life assessment in patients who are receiving treatment for stomach cancer. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: quality-of-life assessment 
Start Date: 2001-04 
Last Updated: 2012-08-27 
Number of Patients: 267 
Recruitment Status: COMPLETED 
Condition: Gastric Cancer 

NCTID: NCT04994717

Title: Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia 
Study Summary: The safety run-in part of the study aims to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy. The phase 3 part of the study aims to compare event-free survival (EFS) and overall survival (OS) of participants receiving blinatumomab alternating with low-intensity chemotherapy to EFS and (OS) of participants receiving standard of care (SOC) chemotherapy. 
Sponsor: Amgen 
Intervention: Blinatumomab 
Start Date: 2021-11-02 
Last Updated: 2023-11-18 
Number of Patients: 287 
Recruitment Status: RECRUITING 
Condition: Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL) 

NCTID: NCT04647526

Title: Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment 
Study Summary: The purpose of this study is to evaluate the efficacy and safety of <math display="block">Lu-177</math>-PNT2002 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with androgen receptor axis-targeted therapy (ARAT). 
Sponsor: POINT Biopharma 
Intervention: [Lu-177]-PNT2002 
Start Date: 2021-02-25 
Last Updated: 2023-11-02 
Number of Patients: 415 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Metastatic Castration-Resistant Prostate Cancer 

NCTID: NCT00002926

Title: Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.  PURPOSE: Randomized phase III trial to compare the effectiveness of peripheral stem cell transplantation with high-dose cytarabine in treating patients with myelodysplastic syndrome or acute myelogenous leukemia. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: cytarabine 
Start Date: 1996-12 
Last Updated: 2010-05-27 
Number of Patients: 80 
Recruitment Status: UNKNOWN 
Condition: Leukemia 

NCTID: NCT03961217

Title: Return to Work Among Cancer Survivors With Treatment-induced Survivorship Syndromes 
Study Summary: The investigators plan to investigate the consequences of late effects (radiation-induced survivorship syndromes) after radiotherapy in Gynecological and Prostate cancer survivors on return to work (Yes 

o) and if RTW happened then time to RTW. In addition, whether general health, type of work (occupation), work environment factors, individual factors (lifestyle, socioeconomic status etc.), contribute to the adverse late effects of radiotherapy and these Gynecological cancer survivors have a higher risk for disability pension/long term sickness absence (NOT Return to work).

Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Radiotherapy 
Start Date: 1991-01 
Last Updated: 2019-05-28 
Number of Patients: 2135 
Recruitment Status: COMPLETED 
Condition: Gynecologic Cancer 

NCTID: NCT04530708

Title: Addition of Radiotherapy to Standard Medical Treatment for Stage IV NSCLC 
Study Summary: The hypothesis for this study is that addition of a moderate dose of radiotherapy to the primary tumor and mediastinal nodes after three months of medical treatment could reduce the tumor burden, partly as an abscopal effect, and thereby improving quality of life and possible also prolonging survival for stage IV NSCLC. 
Sponsor: Swedish Lung Cancer Study Group 
Intervention: Thoracic radiotherapy 
Start Date: 2017-02-01 
Last Updated: 2020-08-28 
Number of Patients: 162 
Recruitment Status: RECRUITING 
Condition: Radiotherapy 

NCTID: NCT04736706

Title: A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012) 
Study Summary: The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC).  The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2021-04-14 
Last Updated: 2023-11-24 
Number of Patients: 1653 
Recruitment Status: RECRUITING 
Condition: Carcinoma, Renal Cell 

NCTID: NCT01080391

Title: Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma 
Study Summary: The primary objective was to compare progression-free survival in adults with relapsed multiple myeloma who are receiving CRd vs participants receiving Rd in a randomized multicenter setting. 
Sponsor: Amgen 
Intervention: Dexamethasone 
Start Date: 2010-07-14 
Last Updated: 2022-09-21 
Number of Patients: 792 
Recruitment Status: COMPLETED 
Condition: Relapsed Multiple Myeloma 

NCTID: NCT02684006

Title: A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101) 
Study Summary: This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma 
Sponsor: Pfizer 
Intervention: Avelumab (MSB0010718C) 
Start Date: 2016-03-23 
Last Updated: 2023-11-09 
Number of Patients: 888 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Renal Cell Cancer 

NCTID: NCT01506609

Title: Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer 
Study Summary: The primary objective of the study is to assess the progression-free survival (PFS) of oral veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and locally recurrent or metastatic breast cancer. 
Sponsor: AbbVie 
Intervention: Placebo 
Start Date: 2012-01-23 
Last Updated: 2021-10-25 
Number of Patients: 294 
Recruitment Status: COMPLETED 
Condition: Metastatic Breast Cancer 

NCTID: NCT00085709

Title: S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML 
Study Summary: RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop cancer cells from dividing so they stop growing and die. Monoclonal antibodies, such as gemtuzumab ozogamicin, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with gemtuzumab ozogamicin may kill more cancer cells. It is not yet known whether induction therapy using cytarabine and daunorubicin is more effective with or without gemtuzumab ozogamicin or whether postconsolidation therapy using gemtuzumab ozogamicin is more effective than no additional therapy in treating de novo (first occurrence) acute myeloid leukemia.  PURPOSE: This randomized phase III trial is comparing two different regimens of chemotherapy and monoclonal antibody therapy to see how well they work in treating patients with previously untreated de novo acute myeloid leukemia. 
Sponsor: SWOG Cancer Research Network 
Intervention: gemtuzumab ozogamicin 
Start Date: 2004-07 
Last Updated: 2015-09-30 
Number of Patients: 637 
Recruitment Status: COMPLETED 
Condition: Leukemia 

NCTID: NCT03859427

Title: A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma 
Study Summary: Compare efficacy of 56 mg/m2 carfilzomib administered once-weekly in combination with lenalidomide and dexamethasone (KRd 56 mg/m2) to 27 mg/m2 carfilzomib administered twice-weekly in combination with lenalidomide and dexamethasone (KRd 27 mg/m2) in subjects with relapsed or refractory multiple myeloma (RRMM) with 1 to 3 prior lines of therapy. 
Sponsor: Amgen 
Intervention: Carfilzomib 
Start Date: 2019-05-08 
Last Updated: 2023-10-27 
Number of Patients: 454 
Recruitment Status: COMPLETED 
Condition: Relapsed or Refractory Multiple Myeloma 

NCTID: NCT02920008

Title: Phase 3 Randomized, Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia 
Study Summary: Multicenter, randomized, open-label, parallel-group study of guadecitabine vs treatment choice (TC). Participants will be randomly assigned in a 1:1 ratio to either guadecitabine or TC. TC options include the 8 high or low intensity, locally available regimens below; or Best supportive Care (BSC) alone:  * High intensity (intermediate or high dose cytarabine <math display="block">HiDAC</math>; mitoxantrone, etoposide, and cytarabine <math display="block">MEC</math>; or fludarabine, cytarabine, granulocyte colony stimulating factor <math display="block">G-CSF</math>, +/- idarubicin <math display="block">FLAG/FLAG-Ida</math>). * Low intensity (low dose cytarabine <math display="block">LDAC</math>, decitabine, or azacitidine). * BSC. 
Sponsor: Astex Pharmaceuticals, Inc. 
Intervention: guadecitabine 
Start Date: 2017-03-16 
Last Updated: 2023-05-25 
Number of Patients: 302 
Recruitment Status: COMPLETED 
Condition: Acute Myeloid Leukemia 

NCTID: NCT01212991

Title: A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer 
Study Summary: The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy. 
Sponsor: Pfizer 
Intervention: Enzalutamide 
Start Date: 2010-09-16 
Last Updated: 2020-03-17 
Number of Patients: 1717 
Recruitment Status: COMPLETED 
Condition: Prostate Cancer 

NCTID: NCT04130971

Title: Predicting Colorectal Cancer - Tissue Samples to Evaluate Tumour Characteristics and Treatment Response 
Study Summary: All adult patients with colorectal cancer presenting within the Sahlgrenska University Hospital or treated at any time at Sahlgrenska University Hospital are eligible and will be asked to participate. We already have biopsies taken at surgery in patients that receive surgery, but this study will include all patients and the biopsies will be taken during endoscopy for diagnosis of the primary tumour. Biopsies will then be taken during follow-up exams prior surgery but after neoadjuvant treatment. Biopsies will also be taken during surgery and in cases where surgery is not necessary biopsies will be taken regularly during follow-up exams.  Blood samples and in relevant cases urinary samples and mouth swabs will be taken at all timepoints when biopsies are taken. If it is not possible to take biopsies prior treatment blood samples will still be drawn. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: No intervention, just observation 
Start Date: 2019-02-01 
Last Updated: 2023-11-07 
Number of Patients: 800 
Recruitment Status: RECRUITING 
Condition: Colorectal Neoplasms 

NCTID: NCT03206671

Title: Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents 
Study Summary: The trial B-NHL 2013 is a collaborative prospective, multi-national, multi-center, randomized trial with participating centers of the NHL-BFM group (Austria, Switzerland, Czech Republic, Germany) and the Scandinavian NOPHO group (Denmark, Finland, Norway, Sweden). The aim of the trial is to evaluate the role of rituximab in the treatment of mature aggressive B-cell Non-Hodgkin lymphoma and leukemia (B-NHL and B-AL) in children and adolescents.  The following primary study questions are going to be analyzed:  * the effectiveness (event-free survival) in pediatric patients with very limited mature B-NHL (R1 and R2 stage I and II) of substituting anthracyclines by the rituximab window without compromising survival rates. * the effectiveness (event-free survival) in pediatric patients with limited mature B-NHL (R2 stage III) randomly assigned to receive the rituximab window plus standard chemotherapy or standard chemotherapy without the rituximab window. * the effectiveness (event-free survival) and the immune reconstitution (recovery of CD19+ B-cells, IR) in pediatric patients with advanced mature B-NHL/B-AL (R3 and R4 incl. R4 CNS+) treated with BFM-type chemotherapy and randomly assigned schedules of one versus seven doses rituximab.  Secondary study questions will address  * additional parameters for immune reconstitution, lymphocyte subpopulations, immunoglobulin levels, vaccination titers and infection rates * kinetics of immune reconstitution after treatment * adverse event and severe adverse event profile * inter-individual variability of rituximab response * role of different mechanisms of action of rituximab in advanced B-NHL/B-AL 
Sponsor: University Hospital Muenster 
Intervention: Rituximab window 
Start Date: 2017-08-03 
Last Updated: 2021-06-08 
Number of Patients: 650 
Recruitment Status: RECRUITING 
Condition: Mature B-cell Non-Hodgkin Lymphoma 

NCTID: NCT01246739

Title: Adrenalectomy Versus Follow-up in Patients With Subclinical Cushings Syndrome 
Study Summary: Incidental findings of adrenal tumours,“incidentalomas”, occur in 1-5 % in the general population and 10-25 % of these patients will exhibit biochemical mild hypercortisolism. Although the patients do not have clinical signs of classical Cushing’s syndrome, they have an increased risk for hypertension, dyslipidemia, diabetes mellitus, osteoporosis and obesity.  The hypothesis of the study is, that surgery of the adrenal adenoma responsible for the increased secretion of cortisol, will in part cure or ameliorate the metabolic syndrome. 
Sponsor: Region Skane 
Intervention: Adrenalectomy 
Start Date: 2011-06 
Last Updated: 2023-04-03 
Number of Patients: 34 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Adrenal Tumour With Mild Hypercortisolism 

NCTID: NCT03193671

Title: Evaluation and Implementation of New Biomarkers and Algorithms for Diagnosis of Ovarian Cysts/Tumors in the Pelvis 
Study Summary: This study evaluates the biomarkers CA125 and HE4 and the algorithms RMI and ROMA on a normal population in the western region of Sweden. The aim is to improve diagnosis of ovarian cancer.  If the investigators observe a clear improvement in the early diagnosis of EOC, the investigators aim to implement the best strategy for all patients with suspected pelvic tumor mass in the western region of Sweden. 
Sponsor: Göteborg University 
Intervention: Diagnosis 
Start Date: 2013-09-01 
Last Updated: 2017-08-29 
Number of Patients: 684 
Recruitment Status: COMPLETED 
Condition: Ovarian Neoplasms 

NCTID: NCT02568839

Title: Neoadjuvant Response-guided Treatment of HER2 Positive Breast Cancer 
Study Summary: The purpose of this trial is to evaluate efficacy and toxicity of either the combination of docetaxel, trastuzumab sc and pertuzumab (arm A) or trastuzumab emtansin (arm B). Switch of therapy to the opposite treatment alternative is applicable in case of lack of response after two courses of treatment, or for medical reasons under exceptional circumstances (drug reaction, other medical conditions) at any point. After termination of the primary treatment follow-up for five years.  A translational subprotocol is a mandatory part of the study protocol, with exception for the use of PET-CT evaluations. 
Sponsor: Thomas Hatschek 
Intervention: docetaxel + trastuzumab sc + pertuzumab 
Start Date: 2014-11 
Last Updated: 2020-08-13 
Number of Patients: 202 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Early-Stage Breast Carcinoma 

NCTID: NCT04923893

Title: A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy 
Study Summary: The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS). 
Sponsor: Janssen Research & Development, LLC 
Intervention: Bortezomib 
Start Date: 2021-08-19 
Last Updated: 2023-11-09 
Number of Patients: 650 
Recruitment Status: RECRUITING 
Condition: Multiple Myeloma 

NCTID: NCT02678975

Title: Disulfiram in Recurrent Glioblastoma 
Study Summary: Disulfiram (Antabuse®) is a well-tolerated, cheap, generic drug that has been in use since the 1950s to treat alcoholism. There is now an increasing amount of independent preclinical data to support disulfiram as an anticancer agent. The potency of disulfiram as an anticancer agent seems strengthened by copper.  The investigators aim is to investigate disulfiram and copper-supplement as add-on treatment in glioblastoma patients with recurrence receiving alkylating chemotherapy. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Disulfiram 
Start Date: 2017-01 
Last Updated: 2021-03-18 
Number of Patients: 88 
Recruitment Status: COMPLETED 
Condition: Glioma 

NCTID: NCT03504293

Title: The Diagnostic Value of Combinatory EUS and ERCP in Unclear Lesions 
Study Summary: ERCP with brush cytology has a poor to moderate accuracy in unclear biliary lesions. Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) for cytology may override some of these shortcomings.  The current prospective study, performed in a tertiary University center, aims to study the feasibility, the accuracy and the clinical value of combinatory ERCP and EUS in unclear biliary lesions. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Combinatory EUS and ERCP 
Start Date: 2010-01-01 
Last Updated: 2020-12-22 
Number of Patients: 90 
Recruitment Status: COMPLETED 
Condition: Neoplasms 

NCTID: NCT04924075

Title: Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015) 
Study Summary: This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Belzutifan 
Start Date: 2021-08-12 
Last Updated: 2023-11-27 
Number of Patients: 322 
Recruitment Status: RECRUITING 
Condition: Pheochromocytoma/Paraganglioma 

NCTID: NCT03654950

Title: Patient Empowerment With the Patient Perspective 
Study Summary: The overall aim with this study is to gain a deeper understanding of patient perceptions regarding empowerment in relation to a health platform. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: No intervention 
Start Date: 2018-06-01 
Last Updated: 2022-11-07 
Number of Patients: 200 
Recruitment Status: COMPLETED 
Condition: Colorectal Cancer 

NCTID: NCT00598845

Title: Molecular Markers in Treatment in Endometrial Cancer 
Study Summary: The purpose of this prospective multicenter trial is to investigate the value of molecular markers in endometrial cancer for predicting lymph node metastasis and prognosis in relation to treatment. 
Sponsor: University of Bergen 
Intervention: Tumor biopsy study 
Start Date: 2001-04 
Last Updated: 2014-12-23 
Number of Patients: 1000 
Recruitment Status: UNKNOWN 
Condition: Endometrial Neoplasms 

NCTID: NCT04788368

Title: TRECA - TREatment of Colorectal Adenomas and Early Colorectal CAncer in Region Västra Götaland 
Study Summary: All early colorectal cancers (T1-T2) treated in the Region Västra Götaland from 2007-2020 will be evaluated. To establish the extent to which early colorectal cancers have been treated with local excision? How have treatment strategies changed over time? The study will provide information on where these patients have been treated in the Region Västra Götaland. During the study period, ESD was introduced as a treatment modality, and it will investigated how this may have influenced treatment strategies for complex adenomas. Clinical outcome measures will include recurrence rates and re-intervention rates for the respective treatments. Possible areas of improvement will be identified and determine if evidence based and best practice guidelines are met with the current treatment strategies in Region Västra Götaland. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Surgical resection 
Start Date: 2021-03-01 
Last Updated: 2022-11-07 
Number of Patients: 300 
Recruitment Status: COMPLETED 
Condition: Rectal Neoplasms 

NCTID: NCT00094497

Title: Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment (FIRM-ACT) 
Study Summary: The purpose of this study is to determine whether treatment with etoposide, doxorubicin, cisplatin and mitotane (EDP/M) prolongs survival as compared to streptozotocin and mitotane (Sz/M) in patients with advanced adrenocortical carcinoma (ACC) whose disease is not amenable to complete surgical resection. 
Sponsor: Collaborative Group for Adrenocortical Carcinoma Treatment 
Intervention: Etoposide 
Start Date: 2004-06 
Last Updated: 2016-09-21 
Number of Patients: 304 
Recruitment Status: COMPLETED 
Condition: Carcinoma, Adrenal Cortical 

NCTID: NCT03066167

Title: Validation of Instruments Used for Assessment of Dysphagia in Patients With Esophageal Cancer 
Study Summary: This study validates 3 well known dysphagia scores for dysphagia due to malignancies of the oesophagus and gastro-oesophageal junction and to the Swedish language. 
Sponsor: Vastra Gotaland Region 
Intervention: Validation of different dysphagia scores 
Start Date: 2010-11 
Last Updated: 2020-07-28 
Number of Patients: 64 
Recruitment Status: COMPLETED 
Condition: Dysphagia, Esophageal 

NCTID: NCT00036543

Title: A Study of Atrasentan in Men With Metastatic, Hormone-Refractory Prostate Cancer 
Study Summary: This study is being done to evaluate the safety and efficacy of atrasentan in men with metastatic hormone-refractory prostate cancer. 
Sponsor: Abbott 
Intervention: Atrasentan 
Start Date: 2001-05 
Last Updated: 2006-08-15 
Number of Patients: 1000 
Recruitment Status: COMPLETED 
Condition: Prostate Cancer 

NCTID: NCT05583097

Title: The Ultracyt Study - is EU-TIRADS Useful in Selecting Nodules for Fine Needle Aspiration Cytology? 
Study Summary: This is a randomized study evaluating selective fine-needle aspiration cytology based on structured ultrasound using EU-TIRADS versus non-selective ultrasound guided cytology. Primary outcome is frequency of suspicious cytology (Bethesda III-VI) which is expected to be higher in the selective group compared to the non-selective group. Secondary outcome is the frequency of malignancy which is expected to be equal in both groups. However, the investigators do not expect to reach statistical significance for the secondary outcome according to power calculations. 
Sponsor: Vastra Gotaland Region 
Intervention: Non-selective cytology 
Start Date: 2022-02-15 
Last Updated: 2023-04-26 
Number of Patients: 200 
Recruitment Status: RECRUITING 
Condition: Thyroid Cancer 

NCTID: NCT01307397

Title: A Study of Vemurafenib in Participants With Metastatic Melanoma 
Study Summary: This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer <math display="block">AJCC</math>) metastatic melanoma. 
Sponsor: Hoffmann-La Roche 
Intervention: Vemurafenib 
Start Date: 2011-03-01 
Last Updated: 2017-12-18 
Number of Patients: 3219 
Recruitment Status: COMPLETED 
Condition: Malignant Melanoma 

NCTID: NCT05359783

Title: Sentinel Node Localization and Staging With Low Dose Superparamagnetic Iron Oxide 
Study Summary: Sentinel lymph node (SLN) status is pivotal for treatment decisions in breast cancer patients. The dual technique with Technetium99m (Tc99) and blue dye (BD) is yet the current routine for SLN detection. However, the same reliability has been presented by superparamagnetic iron oxide nanoparticles (SPIO). The aim of this study was to determine if SLN detection using ultra-low dose SPIO is feasible. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Superparamagnetic Iron Oxide 
Start Date: 2021-11-01 
Last Updated: 2023-04-06 
Number of Patients: 50 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT00049595

Title: Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin’s Lymphoma 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating stage III or stage IV Hodgkin’s lymphoma.  PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have stage III or stage IV Hodgkin’s lymphoma. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: bleomycin sulfate 
Start Date: 2002-08 
Last Updated: 2023-11-09 
Number of Patients: 552 
Recruitment Status: COMPLETED 
Condition: Lymphoma 

NCTID: NCT02997995

Title: Durvalumab and Endocrine Therapy in ER+/Her2- Breast Cancer After CD8+ Infiltration Effective Immune-Attractant Exposure 
Study Summary: This is an open-label, multicentric, international, phase II trial testing aromatase inhibitors in combination with durvalumab in patients with CD8+ T cell infiltration (>10% CD8+ T cells in the tumor). The trial includes two sequences: The first part of the treatment will consist in 4-6 weeks treatment with immune-attractants; in the second part, CD8+ patients will receive 6 months of durvalumab combined with exemestane. 
Sponsor: UNICANCER 
Intervention: Immune-attractant 
Start Date: 2017-02-15 
Last Updated: 2020-09-30 
Number of Patients: 61 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT03515837

Title: Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With Tyrosine Kinase Inhibitor- (TKI)-Resistant Epidermal Growth Factor Receptor- (EGFR)-Mutated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-789/KEYNOTE-789) 
Study Summary: The purpose of this study is to evaluate the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab (MK-3475; KEYTRUDA®) in the treatment of adults with the following types of tyrosine kinase inhibitor (TKI)-resistant, epidermal growth factor receptor (EGFR)-mutated, metastatic non-squamous non-small cell lung cancer (NSCLC) tumors: 1) TKI-failures (including osimertinib <math display="block">TAGRISSO®</math> failure) with T790M-negative mutation tumors, 2) T790M-positive mutation tumors with prior exposure to osimertinib, and 3) first-line osimertinib failure regardless of T790M mutation status.  The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy has superior efficacy compared to saline placebo plus chemotherapy in terms of: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review, and 2) Overall Survival (OS). This study will be considered to have met its success criteria if the combination of pembrolizumab plus chemotherapy is superior to saline placebo plus chemotherapy in terms of PFS or OS.  Upon study completion, participants are discontinued and may be enrolled in a pembrolizumab extension study, if available. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: pembrolizumab 
Start Date: 2018-06-29 
Last Updated: 2023-10-11 
Number of Patients: 492 
Recruitment Status: COMPLETED 
Condition: Non-small Cell Lung Cancer 

NCTID: NCT03364114

Title: Endorotor Resection In Refractory Barrett’s Dysplasia Patients 
Study Summary: The aim of the clinical trial is to evaluate the EndoRotor®’s ability to completely remove areas of Barrett’s esophagus considered refractory after 3 failed ablation treatments (Radiofrequency Ablation (RFA) and/or Cryotherapy) or in patients with at least 1 failed ablative procedure (RFA and/or Cryotherapy) and are intolerant to the procedure due to pain, where intolerant is defined as post-dysphagia or odynophagia persisting for 24 hours or greater or requiring narcotic analgesia for a duration of more than 24 hours. 
Sponsor: Interscope, Inc. 
Intervention: EndoRotor Mucosal Resection System 
Start Date: 2018-02-09 
Last Updated: 2022-08-03 
Number of Patients: 120 
Recruitment Status: RECRUITING 
Condition: Barrett’s Esophagus With Dysplasia 

NCTID: NCT01928537

Title: Efficacy and Safety of IV Rigosertib in MDS Patients With Excess Blasts Progressing After Azacitidine or Decitabine 
Study Summary: This study will examine the effect intravenously administered rigosertib has on the relationship between bone marrow blasts response and overall survival in myelodysplastic syndromes (MDS) patients who have 5-30% bone marrow blasts and who progressed on or after treatment with azacitidine or decitabine. 
Sponsor: Onconova Therapeutics, Inc. 
Intervention: rigosertib sodium 
Start Date: 2013-08 
Last Updated: 2020-06-30 
Number of Patients: 67 
Recruitment Status: COMPLETED 
Condition: Myelodysplastic Syndromes 

NCTID: NCT03927183

Title: Extended Support for Persons With Pituitary Tumours After Surgery 
Study Summary: Patients with pituitary tumours often live with life-long consequences of their disease. Treatment options include surgery, radiotherapy and medical therapy. Symptoms associated with the tumour and/or its treatment affects several areas of life. The year after pituitary surgery constitutes an important time-period with medical evaluations of surgery and decisions on hormonal substitution. The development and evaluation of extended patient support during this time-point is limited. Care based on person-centredness has exclusively been promoted which comprises a care where care providers inquire how patients view their health situation and what their needs, resources, and preferences are. Person-centredness focuses on preserving patient autonomy, function, and well-being and strives to emphasize patient involvement through equalizing power between health care professionals and the patient with the main goal of an enhanced health situation. The aim of the study is to evaluate if a support within a person-centered care practice one year after surgery increases wellbeing for patients with pituitary tumours. 
Sponsor: Göteborg University 
Intervention: person-centred practice 
Start Date: 2017-12-06 
Last Updated: 2019-04-29 
Number of Patients: 90 
Recruitment Status: UNKNOWN 
Condition: Pituitary Tumor Benign 

NCTID: NCT04126655

Title: Modelle 001, TS-inhibition in Colorectal Liver Metastases Comparing Arfolitixorin and Calciumfolinate 
Study Summary: A study that is blinded to the patient and the investigator where the combination of Arfolitixorin + 5-FU is compared to Calciumfolinate + 5-FU. The patients will be randomised and will receive the above described combination as IV bolus injections, peroperatively in conjuction with collection of the first tissue sample.  A low dose (30 mg) and a high dose (120) mg of Arfolitixorin will be used in order to investigate the relation between dose of Arfolitixorin and TS-inhibition. 
Sponsor: Vastra Gotaland Region 
Intervention: Arfolitixorin 
Start Date: 2020-02-05 
Last Updated: 2020-08-27 
Number of Patients: 30 
Recruitment Status: UNKNOWN 
Condition: Metastatic Colorectal Cancer 

NCTID: NCT04332822

Title: A Randomized, Multicenter, Phase III Trial Comparing Treatment With R-mini-CHOP With R-mini-CHP + Polatuzumab Vedotin in Patients With Diffuse Large Cell B Cell Lymphoma 
Study Summary: This is a phase III, randomized, open-label, multicenter trial, conducted in Sweden, Norway, Finland, Denmark, Italy and Switzerland, in elderly patients with untreated diffuse large B-cell lymphoma. Elderly is defined as either ≥80 years of age, or ≥75 years and frail, according to a simplified Comprehensive Geriatric Assessment. Patients will be randomized 1:1 to either the standard treatment for this population, R-miniCHOP, or an experimental regimen, R-pola-miniCHP, where vincristine is substituted by an immunoconjugate, polatuzumab vedotin. The duration of the screening period is up to 4 weeks. The duration of active treatment is 18 weeks in both arms, and patients will be followed up to 36 months after end of treatment. Start of enrollment is planned in Q1 2020, and the last visit of the last patient included (end of trial) is estimated in Q1 2026. 
Sponsor: Nordic Lymphoma Group 
Intervention: R-pola-mini-CHP 
Start Date: 2020-08-19 
Last Updated: 2021-07-09 
Number of Patients: 200 
Recruitment Status: RECRUITING 
Condition: DLBCL 

NCTID: NCT04792892

Title: ANCA II - Quality of Life and Functional Outcome in Patients With Anal Cancer 
Study Summary: Anal cancer is a rare disease, but the incidence is rising. About 200 patients will get this type of cancer yearly in Sweden. Curative treatment includes chemotherapy and radiotherapy. The prognosis is good, but some patients will have recurrent or persistent disease after concluded chemo-radiotherapy and will then be offered salvage surgery. Some patients develop distant metastases that can be treated with good results.  The aim of this study is to identify and describe functional outcome in patients diagnosed with anal cancer. We will study patients from diagnosis, try to identify early toxicity to treatment and then identify long-term morbidity. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Questionnaires 
Start Date: 2021-08-01 
Last Updated: 2022-11-07 
Number of Patients: 600 
Recruitment Status: RECRUITING 
Condition: Anal Cancer 

NCTID: NCT04350021

Title: Effect of Low Dose Metronomic Chemotherapy in Metastatic Breast Cancer 
Study Summary: Low dose metronomic chemotherapy (LDMC) in patients with metastatic breast cancer (MBC) is used as a palliative regiment with the aim to prolong and improve quality of life. The effect of LDMC is not fully elucidated. The aim is to evaluate the effect of LDMC with Capecitabine and Cyclophosphamide (CX) and to discover new potential predictive markers and potential markers for monitoring treatment effect. 
Sponsor: Vastra Gotaland Region 
Intervention: Capecitabine, Cyclophosphamide 
Start Date: 2019-03-01 
Last Updated: 2022-10-13 
Number of Patients: 40 
Recruitment Status: RECRUITING 
Condition: Breast Cancer Metastatic 

NCTID: NCT02697630

Title: Efficacy Study of Pembrolizumab With Entinostat to Treat Metastatic Melanoma of the Eye 
Study Summary: The purpose of this study is to see if the combination of entinostat and pembrolizumab can be an effective treatment for patients with melanoma of the eye (uveal melanoma) that has spread to other sites of the body (metastatic disease). Pembrolizumab is an antibody that helps the immune system to attack cancer cells. Although pembrolizumab has proven clinical efficacy in treating patients with metastatic cutaneous melanoma, an effect on metastatic uveal melanoma has not been established. Entinostat is a histone deacetylase (HDAC) inhibitor that has effects on both cancer cells and immune regulatory cells, thus potentially enhancing the effects of immunotherapy. 
Sponsor: Vastra Gotaland Region 
Intervention: Pembrolizumab 
Start Date: 2018-02-21 
Last Updated: 2019-10-16 
Number of Patients: 29 
Recruitment Status: UNKNOWN 
Condition: Metastatic Uveal Melanoma 

NCTID: NCT04161092

Title: The Swedish Study of Liver Transplantation for Non-resectable Colorectal Cancer Metastases 
Study Summary: To evaluate if the addition of liver transplantation primarily utilizing liver grafts from extended criteria donors not utilized for approved indications to conventional treatment of non-resectable/ non-abatable colorectal liver metastases (CLM) increases overall survival compared to best alternative care. 
Sponsor: Vastra Gotaland Region 
Intervention: Liver transplantation Ltx 
Start Date: 2020-12-01 
Last Updated: 2021-01-05 
Number of Patients: 45 
Recruitment Status: RECRUITING 
Condition: Colorectal Cancer 

NCTID: NCT04005521

Title: Randomized Study Regarding Preventive Jaw- and Swallowing Intervention for Patients With Head and Neck Cancer 
Study Summary: The study includes patients with tumors of the oropharynx, larynx and hypopharynx scheduled to receive radiotherapy with curative intent (+/- chemotherapy). The patients will be randomized into either an intervention group (performing a preventive jaw- and swallowing exercise protocol before and during radiotherapy) or a control group no performing a exercise protocol. All patients will be encouraged to eat or drink for as long as possible during the therapy. All patients will meet with a speech-language therapist weekly during radiotherapy. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Preventive intervention 
Start Date: 2019-06-13 
Last Updated: 2023-09-21 
Number of Patients: 80 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Head and Neck Neoplasm 

NCTID: NCT04152512

Title: Quality of Life, Unmet Needs and Satisfaction With Care After Vulvar Cancer 
Study Summary: The aim of this prospective, longitudinal Swedish multi-center study is to assess the quality of life, treatment-related morbidity, unmet needs and satisfaction with care after treatment for vulvar cancer, evaluated by a validated questionnaire. 
Sponsor: Karolinska University Hospital 
Intervention: Questionnaire administration 
Start Date: 2019-08-29 
Last Updated: 2023-11-01 
Number of Patients: 153 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Vulvar Cancer 

NCTID: NCT01524848

Title: Pazopanib in Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib 
Study Summary: Patients with metastatic or locally advanced gastrointestinal stromal tumors (GIST) who develop resistance against the two hitherto approved drugs for this disease, the tyrosin kinase inhibitors (TKIs) imatinib and sunitinib, have a poor prognosis. Sometimes a further response may be achieved by other drugs, mainly other TKIs, which have been explored in different studies but not yet have been approved for clinical use. Pazopanib is a TKI inhibiting the tyrosin kinases KIT, PDGFRA, and VEGF 1-3, all of which have important roles in the pathogenesis of GIST. Theoretically, it may function in GIST, and it deserves investigational trials. The drug is approved for metastatic renal cancer and is relatively well tolerated. In this trial (SSG XXI), the disease control rate (DCR) = (CR+PR+SD) after 12 weeks of treatment will be assessed as the primary endpoint, and at the same time trough levels will be measured. Secondary endpoints include ORR, PFS, toxicity, and disease control rate in relation to trough level week 12 and in relation to the primary mutation of the tumor (if known). The goal is to include 72 patients in the trial, which is open and single arm. 
Sponsor: Scandinavian Sarcoma Group 
Intervention: Pazopanib 
Start Date: 2012-02 
Last Updated: 2017-05-10 
Number of Patients: 72 
Recruitment Status: COMPLETED 
Condition: Gastrointestinal Stromal Tumors 

NCTID: NCT04701151

Title: NORTH-REG Dwell-Time Study 
Study Summary: Previous studies show that the majority NMIBC patients experience side effects to BCG and therefore terminate the instillations before completing all planned instillations. This will increase their risk of recurrence and potential cystectomy. The purpose of this study is to investigate if NMIBC patients who experience severe side effects to BCG instillations will experience fewer or less severe side effects if reducing dwell-time of BCG instillations.  The study will include patients from Denmark, Iceland, Norway and Sweden. 
Sponsor: Jørgen Bjerggaard Jensen 
Intervention: Bacillus Calmette Guerin 
Start Date: 2021-02-03 
Last Updated: 2023-05-01 
Number of Patients: 314 
Recruitment Status: RECRUITING 
Condition: Side Effect of Drug 

NCTID: NCT00963651

Title: GE Healthcare VolumeRAD Lung Nodule Detection Study 
Study Summary: To perform a multiple reader, multiple case (MRMC) observer study assessing the detection performance of VolumeRAD tomosynthesis of the chest in detecting lung nodules. 
Sponsor: American College of Radiology - Image Metrix 
Intervention: Chest tomosynthesis and X-ray 
Start Date: 2009-08 
Last Updated: 2013-07-24 
Number of Patients: 187 
Recruitment Status: COMPLETED 
Condition: Pulmonary Nodule, Solitary 

NCTID: NCT03116412

Title: A Randomized Trial to Assess the Role of Imaging During Follow up After Radical Surgery of High Risk Melanoma 
Study Summary: It is not known whether radiological assessments during follow up after surgery for high risk melanoma improve survival. Since radiological examinations are resource demanding, could inflict worry and cause irradiation exposure it is an important question to address. With the introduction of effective medical treatments for malignant melanoma patients, there is a tendency to introduce radiological assessments despite the lack of evidence. 
Sponsor: Uppsala University 
Intervention: CT or PET scans 
Start Date: 2017-06-08 
Last Updated: 2019-04-18 
Number of Patients: 1300 
Recruitment Status: RECRUITING 
Condition: Malignant Melanoma 

NCTID: NCT02319837

Title: Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) 
Study Summary: The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both.  The randomized / blinded portion of the study is now completed following primary endpoint analyses. The study remains ongoing in open label format. 
Sponsor: Pfizer 
Intervention: Enzalutamide 
Start Date: 2014-12-17 
Last Updated: 2023-08-08 
Number of Patients: 1068 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Hormone Sensitive Prostate Cancer 

NCTID: NCT05264337

Title: Lymphedema After Urologic Surgery 
Study Summary: Lymphedema of the extremities is common after lymph node surgery in treating several forms of cancer, e.g., breast cancer. However, very little is known of the occurrence of lymphedema of the lower extremities after urologic surgery with lymph node dissection. This project aims to describe the frequency and grade of lymphedema arising after urologic surgery, using the Lymphedema Quality of Life Questionnaire (LymQOL), Delfin MoistureMeter D, and lower limb volume measurements. 
Sponsor: Vastra Gotaland Region 
Intervention: Self-reported lymphedema 
Start Date: 2022-03-14 
Last Updated: 2023-04-27 
Number of Patients: 400 
Recruitment Status: RECRUITING 
Condition: Urinary Bladder Neoplasms 

NCTID: NCT03829033

Title: Photon Therapy Versus Proton Therapy in Early Tonsil Cancer. 
Study Summary: In this trial, patients with early squamous cell carcinoma of the tonsil with clinical stage T1-2 (p16-positive or p16-negative) N0-1 (p16-positive) 

0-N2b (p16-negative) according to American Joint Committee on Cancer (AJCC) 8th edition, aimed for unimodal and ipsilateral treatment with radiotherapy with curative intent will be included. The patients will be randomized to in a 1:1 ratio to receive radiotherapy with either photons (conventional radiotherapy) versus radiotherapy with protons.

Sponsor: Lund University Hospital 
Intervention: Radiotherapy 
Start Date: 2019-01-22 
Last Updated: 2021-09-01 
Number of Patients: 100 
Recruitment Status: RECRUITING 
Condition: Tonsil Cancer 

NCTID: NCT01433614

Title: Epirubicin and Paclitaxel, Alone or Together With Capecitabine as First Line Treatment in Metastatic Breast Cancer 
Study Summary: Anthracycline-taxane regimens are effective means of postponing progression in metastatic breast cancer. It is yet unclear whether addition of capecitabine to this combination improves the treatment outcome.  Patients with advanced breast cancer are randomized to first-line chemotherapy with a combination of epirubicin (Farmorubicin®) and paclitaxel (Taxol®) alone (ET) or in combination with capecitabine (Xeloda®, TEX). Starting doses for ET are epirubicin 75 mg/m2 plus paclitaxel 175 mg/m2, and for TEX epirubicin 75mg/m2, paclitaxel 155 mg/m2, and capecitabine 825 mg/m2 BID for 14 days. Subsequently, doses are tailored related to side effects.  Primary endpoint is progression-free survival (PFS); secondary endpoints are overall survival (OS), time to treatment failure (TTF), objective response (OR), safety and quality of life (QoL). 
Sponsor: Thomas Hatschek 
Intervention: Epirubicin 
Start Date: 2002-12 
Last Updated: 2015-09-17 
Number of Patients: 304 
Recruitment Status: COMPLETED 
Condition: Metastatic Breast Cancer 

NCTID: NCT04114825

Title: Study of RV001V in Biochemical Failure Following Curatively Intended Therapy For Localized Prostate Cancer 
Study Summary: This Phase II trial will enroll approximately 180 adult male patients with an earlier histologic diagnosis of prostatic adenocarcinoma and a biochemical recurrence (BCR) within 3 years of radical prostatectomy (RP) or definitive RT and no distant metastasis or locoregional recurrence. The trial is a randomized placebo-controlled double-blind study of a peptide cancer vaccine (RV001V). 
Sponsor: RhoVac APS 
Intervention: RV001V 
Start Date: 2019-11-19 
Last Updated: 2021-09-28 
Number of Patients: 180 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Prostate Cancer Recurrent 

NCTID: NCT01390948

Title: A Study of Bevacizumab (Avastin) in Combination With Temozolomide (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma 
Study Summary: This randomized, open-label, multicenter, 2-arm study will investigate the efficacy, safety, tolerability and pharmacokinetics of bevacizumab when added to postoperative radiotherapy with concomitant and adjuvant TMZ as compared to postoperative radiotherapy with concomitant and adjuvant TMZ alone in paediatric participants with newly diagnosed histologically confirmed World Health Organization (WHO) Grade III or IV localized supratentorial or infratentorial cerebellar or peduncular high grade glioma (HGG). Participants will be randomly assigned to one of two treatment arms.  Upon approval by the Health Authorities/Ethics Committees in the participating countries, an additional young participant cohort (YPC) (children >/= 6 months and < 3 years of age with progressive or relapsed metastatic or localized, supra- or infratentorial, non-brain stem WHO Grade III or IV HGG) was included in the study. Children in the YPC will receive bevacizumab and TMZ without radiation therapy. The anticipated time on study treatment is over 1 year. 
Sponsor: Hoffmann-La Roche 
Intervention: Bevacizumab 
Start Date: 2011-10-18 
Last Updated: 2020-08-06 
Number of Patients: 124 
Recruitment Status: COMPLETED 
Condition: High Grade Glioma 

NCTID: NCT00876031

Title: Trial for Localised High-risk Rhabdomyosarcoma and Rhabdomyosarcoma-like Soft Tissue Sarcoma 
Study Summary: The purpose of this study is to investigate whether the addition of oral maintenance chemotherapy with O-TIE (Etoposide, Idarubicin, Trofosfamide) for 6 months improves the event free survival (EFS) in patients with localised high-risk RMS and RMS-like Soft Tissue Sarcoma. 
Sponsor: University Hospital Tuebingen 
Intervention: trofosfamide, idarubicin, etoposide 
Start Date: 2009-07-01 
Last Updated: 2022-11-08 
Number of Patients: 195 
Recruitment Status: COMPLETED 
Condition: Soft Tissue Sarcoma 

NCTID: NCT02879721

Title: Expression and Function of the Renin-Angiotensin System in the Esophagus 
Study Summary: Barrett’s esophagus (BE) is the major esophageal pre-neoplastic lesion in which dysplastic transformations eventually can lead to cancer development. Today, the only way for early detection of pre-neoplastic lesions is an endoscopic surveillance programme with tissue sampling for histopathology, the latter being the only validated biomarker for esophageal adenocarcinoma (EAC)-risk available. New biomarkers are warranted for better patient selection before inclusion into BE surveillance programmes.  Epidemiologic studies have demonstrated suppressed numbers of cancer prevalence in cohorts being under different medical treatment. In a British epidemiological study 2007 Sjöberg et al noted a lower prevalence of EAC among patients treated with antihypertensive drugs interfering with the renin-angiotensin system (RAS) such as AT1R-blockers and ACE-inhibitors. The last decade this endocrine signalling system has been proven to be involved in pathological conditions such as inflammation, wound-healing and even cancer, in several organ systems.  Earlier reports from the investigators laboratory indicate the existence of a local RAS in the esophageal wall musculature and in the squamous mucosa. In the investigators latest explorative study, the investigators discovered the altered expression of “classical” RAS components in BE with and without dysplasia (unpublished results).  By a possible alteration in RAS-related protein-expression in BE with increasing grade of dysplasia towards EAC, the investigator may have a possible “pathway” leading to biomarkers for cancer-development. Furthermore, the already well-known anti-hypertensive drugs ACE-inhibitors and AT1R-blockers may interfere with the risk of malignancy in BE. The investigators therefore wish to test, in an exploratory prospective randomized placebo-controlled setting, whether RAS-related protein-expressions in BE are altered by the addition of RAS-suppressant pharmaceuticals. In the same manner the investigators wish to see if the expressions of well-known biomarkers for cancer and inflammation are altered. 
Sponsor: Göteborg University 
Intervention: Candesartan 
Start Date: 2009-10 
Last Updated: 2016-08-26 
Number of Patients: 33 
Recruitment Status: COMPLETED 
Condition: Barrett’s Esophagus 

NCTID: NCT04607421

Title: A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer 
Study Summary: The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that:  * has spread to other parts of the body (metastatic); * has a certain type of abnormal gene called “BRAF”; and * has not received prior treatment.  Participants in this study will receive one of the following study treatments:  * Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection into the vein) at the study clinic. * Encorafenib plus cetuximab with chemotherapy: These participants will receive encorafenib and cetuximab in the way described in the bullet above. Additionally, they will receive standard chemotherapy by IV infusion and oral treatment at home. * Chemotherapy alone: These participants will receive chemotherapy, the standard treatment for this condition, by IV infusion at the study clinics and oral treatment at home.  The study team will monitor how each participant responds to the study treatment for up to about 3 years. 
Sponsor: Pfizer 
Intervention: Encorafenib 
Start Date: 2020-12-21 
Last Updated: 2023-09-11 
Number of Patients: 815 
Recruitment Status: RECRUITING 
Condition: Neoplasms 

NCTID: NCT02102165

Title: AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer. 
Study Summary: This program initially aims to recruit 1300 breast cancer patients from a large number of hospitals across Europe. Eligible patients are those who are 18 or older, either female or male, and who have not received more than 1 type of treatment from the time metastases were discovered, metastasi(e)s has just been diagnosed or their disease has come back (disease relapse). Biopsy samples from both the primary and metastatic (or relapsed) tumor will be collected for central analyses, together with blood, serum and plasma samples. Any samples not analyzed immediately will be stored in an independent bio-repository to enable future (not yet defined) research aimed at better understanding metastatic breast cancer.  In summary, the main objectives of AURORA are to better understand the genetic aberrations in metastatic breast cancer and to discover the mechanisms of response or resistance to therapy, in order to ultimately identify the “right therapy for each individual patient”. At the same time, patients with genetic aberrations that are being targeted by new drugs in development will be offered the possibility to participate in clinical trials, when approved and available in their countries. Ultimately, the aim of AURORA is to improve the outcomes of all patients diagnosed with metastatic breast cancer. 
Sponsor: Breast International Group 
Intervention: metastatic lesion biopsy 
Start Date: 2014-04 
Last Updated: 2023-01-18 
Number of Patients: 1000 
Recruitment Status: SUSPENDED 
Condition: Metastatic Breast Cancer 

NCTID: NCT00989131

Title: Study of Paclitaxel in Patients With Ovarian Cancer 
Study Summary: RATIONALE: Paclitaxel is one of the most widely used human anticancer agents. Paclitaxel has a low degree of solubility and Cremophor EL is typically used as the solubiliser. Cremophor EL is known to cause hypersensitivity reactions that can be life-threatening. As Paclical® does not contain Cremophor EL, hypersensitivity reactions can be expected to be less.  PURPOSE: To study the efficay and safety of two different formulations of paclitaxel, Paclical® and Taxol®. 
Sponsor: Oasmia Pharmaceutical AB 
Intervention: Paclical® 
Start Date: 2009-02 
Last Updated: 2014-02-04 
Number of Patients: 789 
Recruitment Status: COMPLETED 
Condition: Epithelial Ovarian Cancer 

NCTID: NCT00900614

Title: Safety Study of APR-246 in Patients With Refractory Hematologic Cancer or Prostate Cancer 
Study Summary: The purpose of this study is to determine the highest feasible dose (HFD) of intravenous (IV) APR-246 when given to patients with refractory hematologic malignancies or prostate carcinoma. 
Sponsor: Aprea Therapeutics 
Intervention: APR-246 
Start Date: 2009-05 
Last Updated: 2019-07-31 
Number of Patients: 36 
Recruitment Status: COMPLETED 
Condition: Hematologic Neoplasms 

NCTID: NCT01597414

Title: Elderly Metastatic Breast Cancer: Pertuzumab-Herceptin vs Pertuzumab-Herceptin-Metronomic Chemotherapy, Followed by T-DM1 
Study Summary: Chemotherapy and HER2 targeted agents can improve survival significantly in metastatic breast cancer. Chemotherapy however is associated with significant side-effects and can impact on Quality of Life and functionality in older patients.  The investigators aim to establish HER2 targeted regimens with minimal toxicity in order to delay or even avoid the use of classical chemotherapy because of competing risks of death in this frail/elderly patient group. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: Pertuzumab + trastuzumab 
Start Date: 2013-06 
Last Updated: 2022-11-17 
Number of Patients: 80 
Recruitment Status: COMPLETED 
Condition: Elderly Metastatic Breast Cancer Population 

NCTID: NCT02919787

Title: Nordic Pancreatic Cancer Trial (NorPACT) - 1 
Study Summary: This study evaluate the additional effect of adding chemotherapy prior to resection of a pancreatic head malignancy. The patients will be randomized into two groups; surgery first (control group) and neoadjuvant chemotherapy (intervention). Primary endpoint is overall survival after resection 
Sponsor: Oslo University Hospital 
Intervention: 5-FU 
Start Date: 2016-09 
Last Updated: 2023-02-10 
Number of Patients: 140 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Pancreatic Cancer 

NCTID: NCT00003321

Title: Quality-of-Life Assessment of Patients Who Have Cancer of the Esophagus 
Study Summary: RATIONALE: Questionnaires that measure quality of life may improve the ability to plan treatment for patients who have cancer of the esophagus.  PURPOSE: This clinical trial studies quality-of-life assessments of patients with cancer of the esophagus who are receiving treatment. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: psychosocial assessment and care 
Start Date: 1998-02 
Last Updated: 2013-06-12 
Number of Patients: 370 
Recruitment Status: COMPLETED 
Condition: Esophageal Cancer 

NCTID: NCT01558921

Title: Rectal Cancer And Pre-operative Induction Therapy Followed by Dedicated Operation. The RAPIDO Trial 
Study Summary: Currently the 3-year disease free survival of patients with locally advanced rectal cancer is about 50%. Current standard treatment for patients at high risk of failing locally and/or systemically includes pre-operative long course radiotherapy (5 weeks) in combination with chemotherapy (so called neoadjuvant chemoradiotherapy). The neoadjuvant chemoradiotherapy has been demonstrated to improve local control, but had no effect on the overall survival. Different studies in patients with rectal cancer studying the effect of adjuvant post operative chemotherapy did not result in an improved survival. This may be due the fact that rectal cancer surgery (TME) is associated with a high complication rate so substantial proportion of patients cannot receive chemotherapy postoperatively. An alternative approach is to administer the systemic therapy preoperative. To guarantee control of the rectum tumor short-course radiotherapy (5 days) is given, as different studies showed local control of the tumor for a long time. During this waiting period the patient is in a good condition to receive an optimal dose of chemotherapy. The investigators hypothesize that with this proposed protocol both the local tumour and possible micrometastases are effectively treated and that this will result in an increased survival. The investigators will compare this with the standard treatment of neoadjuvant chemoradiation followed by TME surgery and optional adjuvant chemotherapy. 
Sponsor: University Medical Center Groningen 
Intervention: M1 scheme 
Start Date: 2011-06-21 
Last Updated: 2023-01-13 
Number of Patients: 920 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Rectal Cancer 

NCTID: NCT03646955

Title: Partial Breast Versus no Irradiation for Women With Early Breast Cancer 
Study Summary: All early breast cancer patients are offered adjuvant breast radiation therapy (RT) after breast conserving surgery for an early breast cancer. Breast cancer is heterogeneous, and selected patients have a very low gain from RT, whilst they still have risk of acute and late side effects from RT. This trial will try identify selection criteria for low risk breast cancer patients who can safely omit adjuvant RT without unacceptable high risk of local failure. 
Sponsor: Danish Breast Cancer Cooperative Group 
Intervention: No partial breast irradiation 
Start Date: 2018-09-05 
Last Updated: 2020-10-06 
Number of Patients: 926 
Recruitment Status: RECRUITING 
Condition: Local Neoplasm Recurrence 

NCTID: NCT04242329

Title: Surgery of Melanoma Metastases After Systemic Therapy 
Study Summary: To evaluate if surgical removal of residual disease adds benefit in stage IV melanoma patients with partial response or stable disease after a minimum 9 months of first-line PD-1 inhibition. Primary endpoint: Disease-free survival (DFS) at 12 months. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Surgical metastasectomy 
Start Date: 2021-03-11 
Last Updated: 2023-09-21 
Number of Patients: 0 
Recruitment Status: WITHDRAWN 
Condition: Melanoma 

NCTID: NCT00296010

Title: Liposomal Doxorubicin Compared With Observation or Cyclophosphamide and Methotrexate in Treating Older Women Who Have Undergone Surgery for Breast Cancer 
Study Summary: RATIONALE: Drugs used in chemotherapy, such as methotrexate, cyclophosphamide, and liposomal doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving liposomal doxorubicin after surgery is more effective than observation or cyclophosphamide and methotrexate in treating breast cancer.  PURPOSE: This randomized phase III trial is studying liposomal doxorubicin to see how well it works compared with observation or cyclophosphamide and methotrexate in treating older women who have undergone surgery for breast cancer. 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: cyclophosphamide 
Start Date: 2005-08 
Last Updated: 2021-02-23 
Number of Patients: 77 
Recruitment Status: TERMINATED 
Condition: Breast Cancer 

NCTID: NCT01909453

Title: Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma 
Study Summary: This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized.  Part 1:  Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms:  # LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm) # LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or # vemurafenib 960 mg BID (denoted as vemurafenib arm)  Part 2:  Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms:  # LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or # LGX818 300 mg QD monotherapy (denoted as LGX818 arm) 
Sponsor: Pfizer 
Intervention: LGX818 
Start Date: 2013-12-13 
Last Updated: 2023-09-07 
Number of Patients: 921 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Melanoma 

NCTID: NCT05328960

Title: The Pandemic’s Effect on Diagnosis and Treatment of Rectal Cancer 
Study Summary: Colorectal cancer is common with an annual prevalence of 6000. The majority can be cured and the five year survival rate is over 60%. In december 2019 reports came in about SARS-Cov-2, which later was named Covid-19. The World Health Organization classified it as a pandemic in March 2020. In Sweden the number of patients with Covid-19 increased mainly in the urban areas in March 2020. Care for patients with other diseases were affected and local changes from guidelines were adopted. In some regions and countries the indications for adjuvant and neoadjuvant treatment for colorectal cancer were somewhat changed. The number of patients diagnosed with colorectal cancer also decreased, as well as other types of cancer. The true effect on outcome with a delayed diagnosis remains unknown.  The aim of this study is to evaluate the effects of the Covid-19 pandemic on the diagnosis, treatment and survival of patients with colorectal cancer. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Diagnosed during or not during the pandemic 
Start Date: 2022-02-15 
Last Updated: 2022-04-14 
Number of Patients: 8000 
Recruitment Status: RECRUITING 
Condition: Rectal Cancer 

NCTID: NCT04822077

Title: Study on Proton Radiotherapy of Thymic Malignancies 
Study Summary: This is a multicentre non-randomized phase II study of proton beam radiotherapy in patients with thymic epithelial tumours (i.e. thymoma and thymic carcinoma) in the post-operative setting or in inoperable patients with localized disease.  Patients not willing or for any reason unsuitable to undergo proton treatment will be asked to participate in a follow-up assessment after the regular photon treatment in the same manner as the included patients.  Primary endpoints are:Toxicity (e.g. cardiac and pulmonary toxicity) and Local control at 5 year Secondary endpoints: PFS, Overall survival, Quality of life, measured by EORTC QLQ 30 + LC 13 and relapse pattern 
Sponsor: Ass. Prof. Jan Nyman 
Intervention: Proton radiation 
Start Date: 2018-04-18 
Last Updated: 2021-03-30 
Number of Patients: 40 
Recruitment Status: RECRUITING 
Condition: Cardiotoxicity 

NCTID: NCT02115477

Title: Lymphedema After Primary Surgery for Endometrial Cancer 
Study Summary: The purposes of this study are  * to determine the prevalence, size and impact on quality of life of lymphedema of the lower extremities after primary radical surgery with hysterectomy +/- pelvic - and paraaortic lymphadenectomy in women with endometrial uterine carcinoma FIGO (International Federation of Gynecology and Obstetrics) stage 1 and 2 * to analyze risk factors for development of lymphedema in this specific group of patients.  Our hypotheses are that women who have lymphadenectomy more often suffer from lymphedema, subjectively and objectively, and have an impaired quality of life.  This is a Swedish multicenter study carried out in 17 departments of Obstetrics and Gynecology and in 3 departments of Oncology. All participants are treated according to the Swedish National Guidelines for Endometrial Cancer.  130 women with endometrial cancer who have a hysterectomy with lymphadenectomy (high-risk endometrial carcinomas) and 130 women with endometrial cancer who have a hysterectomy without lymphadenectomy (low-risk endometrial carcinomas) are prospectively enrolled in the study.  The participants are examined preoperatively and on 3 occasions postoperatively, i.e. 4-6 weeks , 6 months and 12 months postoperatively.  Determination of occurrence of lymphedema of the lower extremities are determined objectively by 1) a standardized clinical evaluation according to Bruna et al.<math display="block">1</math> and 2) determining the leg volume according to the cone model by Sitzia <math display="block">2</math> by systematically measuring of leg circumferences. In addition, occurrence of lymphedema is measured subjectively by the participants.  On the same four occasions as the leg circumference measurements are conducted the patients complete two generic health related quality of life forms (the EuroQol EQ-5D and the Short-Form 36 SF-36) and the condition specific quality of life form for limb lymphedema (LYMQOL).  Demographic and clinical data are systematically collected until one year postoperatively including occurrence of complications and given adjuvant oncological therapy such as chemo- and radiation therapy.  On each occasion of clinical control a vaginal ultrasound examination is carried out in order to register pelvic and abdominal lymphocele formation or lymphatic fluid effusion intraabdominally. 
Sponsor: Preben Kjolhede, MD, professor 
Intervention: Lymphadenectomy 
Start Date: 2014-04-17 
Last Updated: 2019-10-25 
Number of Patients: 262 
Recruitment Status: COMPLETED 
Condition: Carcinoma of the Endometrium 

NCTID: NCT00002529

Title: Hormone Therapy and Chemotherapy in Treating Perimenopausal or Postmenopausal Women With Node-Positive Breast Cancer 
Study Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the uptake of estrogen. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with hormone therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective for breast cancer.  PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy during or after combination chemotherapy or hormone therapy alone in treating perimenopausal or postmenopausal women who have stage II or stage IIIA breast cancer. 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: cyclophosphamide 
Start Date: 1993-05 
Last Updated: 2013-04-04 
Number of Patients: 452 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT05432297

Title: Preventive Physical Activity Intervention in Head and Neck Cancer 
Study Summary: The study includes patients with tumors of the oropharynx, larynx and hypopharynx scheduled to receive radiotherapy with curative intent (+/- chemotherapy). The patients will be randomized into either an intervention group (performing a preventive physical activity protocol before and during radiotherapy) or a control group not performing a specified physical exercise protocol. All patients will be in contact with with a speech language pathologist or a physical therapist weekly during radiotherapy. The study is expected to improve physical function and quality of life during and after oncologic treatment 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Preventive physical exercise 
Start Date: 2023-01-02 
Last Updated: 2023-09-21 
Number of Patients: 80 
Recruitment Status: RECRUITING 
Condition: Head and Neck Neoplasms 

NCTID: NCT04472429

Title: Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2). 
Study Summary: This study is a Phase 3 global, multicenter, placebo-controlled double-blind randomized study that will enroll participants with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy. 
Sponsor: Incyte Corporation 
Intervention: carboplatin 
Start Date: 2021-01-12 
Last Updated: 2023-07-12 
Number of Patients: 308 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Squamous Cell Carcinoma of the Anal Canal 

NCTID: NCT00966173

Title: International Melanoma Algorithm Training Study - IMATS 
Study Summary: This is an international, multicenter, prospective, non controlled, non randomized, clinical study to collect electrical impedance data of potentially malignant pigmented nevi and histological diagnoses (International Melanoma Algorithm Training Study <math display="block">IMATS</math>). The study objective is to collect data for training and optimization of an algorithm that can classify skin lesions using electrical impedance, i.e., to identify malignant melanomas. 
Sponsor: SciBase AB 
Intervention: SciBase III Electrical Impedance Spectrometer 
Start Date: 2005-12 
Last Updated: 2010-08-11 
Number of Patients: 1800 
Recruitment Status: COMPLETED 
Condition: Malignant Melanoma 

NCTID: NCT04701853

Title: Specific Training After Stoma Surgery 
Study Summary: In Sweden, approximately 43,000 people have undergone surgery with ileo-, colo- or urostomy. The most common type of stomy is a sigmoidostomy. A large proportion, about 50%, of patients who receive a permanent sigmoidostomy develop a parastomal hernia which may have major impact.  There are indications that specific abdominal exercise may reduce the risk of parastomal hernias, but randomized studies are lacking.  The aims of the study are:  # to evaluate the effect of specific exercise to counteract the development of parastomal hernia in sigmoidostomy and the hernia’s impact on ostomy function, physical function and quality of life. # to examine patients’ experience of living with parastomal hernia. The study plans to include 240 patients who on will undergo surgery and receive a sigmoidostomy. These will be randomized to receive only advice according to the usual routine to avoid the development of parastomal hernia or these advice with the addition of specific abdominal muscle training. The training is initiated before the operation and is then carried out during the first postoperative year. Follow-up will be done with a clinical assessment and with measurement of bulge and size of the parastomal hernia manually, with electronic measuring equipment and via computed tomography images. Patients will assess their stoma and stoma function and assess any discomfort and its consequences of hernia via a study-specific questionnaire. Type of ostomy bandage will also be registered. The evaluation will be carried out 6, 12 and 36 months postoperatively.  Prior to the start of sub-study a, the planned measurement methods to assess whether a parastomal hernia is present will be tested for validity. In addition, a group of patients (≥15 people) with parastomal hernia will be included in a qualitative sub-study where they will be interviewed about their experiences of the hernia hernia and how it may affect daily life.  The present study will be able to answer whether specific exercise can reduce the risk of parastomal hernia. Methods for clinically assessing and evaluating bulging and hernias will be tested and evaluated in relation to patient-reported symptoms. In addition, the study will provide information about the patient’s experience of having a parastomal hernia and how it affects daily life and physical activity. The results will provide an increased understanding of parastomal hernias, which may change the follow-up of patients in the future. 
Sponsor: Göteborg University 
Intervention: Specific abdominal muscle training 
Start Date: 2021-05-01 
Last Updated: 2023-02-27 
Number of Patients: 240 
Recruitment Status: RECRUITING 
Condition: Colon Cancer 

NCTID: NCT04460053

Title: Neurofilament Light Protein in Peripheral Blood Used as a Biomarker for Neurotoxicity After Isolated Limb Perfusion. 
Study Summary: A prospective feasibility trial initially including 10 patients to investigate if Neurofilament light protein can be detected in peripheral blood in patients undergoing Isolated Limb Perfusion with chemotherapeutic agents. This biomarker could act as predictive biomarker for neurotoxicity after isolated limb perfusion. 
Sponsor: Roger Olofsson Bagge, MD, PhD 
Intervention: Neurofilament light protein measurement in Isolated limb perfused patients 
Start Date: 2019-04-12 
Last Updated: 2021-03-17 
Number of Patients: 18 
Recruitment Status: COMPLETED 
Condition: Malignant Melanoma 

NCTID: NCT02163694

Title: A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer 
Study Summary: The primary objective of the study is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin and paclitaxel (C/P) compared to placebo plus C/P in participants with a Breast Cancer Gene 1 or 2 (BRCA1; BRCA2) mutation in Human Epidermal Growth Factor Receptor 2 (HER2)-negative metastatic or locally advanced unresectable breast cancer. The secondary objectives of the study are to assess overall survival (OS), clinical benefit rate (CBR) through the end of Week 24, objective response rate (ORR) and PFS on subsequent therapy (PFS2) in participants treated with veliparib in combination with C/P versus placebo in combination with C/P. 
Sponsor: AbbVie 
Intervention: Veliparib Placebo 
Start Date: 2014-07-17 
Last Updated: 2023-02-16 
Number of Patients: 509 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Metastatic Breast Cancer 

NCTID: NCT05028660

Title: AURORAX-0093A: Glycosaminoglycan Profiling for Prognostication of Muscle-invasive Bladder Cancer - a Pilot Study 
Study Summary: AURORAX-0093A (AUR93A) is a pilot cohort observational study that will explore the use of urine and plasma glycosaminoglycans (GAGs) to prognosticate muscle-invasive bladder cancer (MIBC) patients elected for neo-adjuvant chemotherapy (NAC). 
Sponsor: Elypta 
Intervention: GAG score 
Start Date: 2021-07-21 
Last Updated: 2023-05-11 
Number of Patients: 76 
Recruitment Status: RECRUITING 
Condition: Muscle-Invasive Bladder Carcinoma 

NCTID: NCT00300729

Title: Effect of Celecoxib on Survival in Patients With Advanced Non-Small Cell Lung Cancer Receiving Chemotherapy 
Study Summary: The primary purpose of the study is to investigate if daily treatment with celecoxib, an inhibitor of cyclooxygenase-2, can prolong survival in patients with advanced non-small cell lung cancer who receive anticancer chemotherapy as their primary treatment. Secondary endpoints of the study are: health-related quality of life, toxicity, cardiovascular events, progression-free survival, and biological markers (VEGF, proteomics). 
Sponsor: University Hospital, Linkoeping 
Intervention: Celecoxib 
Start Date: 2006-05 
Last Updated: 2009-06-30 
Number of Patients: 319 
Recruitment Status: UNKNOWN 
Condition: Non-Small Cell Lung Cancer 

NCTID: NCT04794777

Title: Comparing “Salvage” Radiotherapy and Individualized PSMA PET/CT Targeted Treatment in With Relapsing Prostate Cancer 
Study Summary: Less than 50% of patients receiving salvage radiation therapy (SRT) to the pelvis as treatment for prostate cancer relapsing after surgery will achieve undetectable Prostate Specific Antigen (PSA) levels. Despite SRT, two-thirds of patients will again develop elevated PSA, 20% will have distant metastases, and 10% will die from prostate cancer within 10 years. The reason for this is probably preexisting distant metastasis and lymph node metastasises which need to better targeted directly. Additionally , there are well known permanent side effects to SRT.  Standard imaging techniques have poor sensitivity detecting recurrence when PSA is below 1.0 ng/ml. The surface protein Prostate-specific membrane antigen (PSMA) is overexpressed on prostate cancer cells and 68Gallium (68Ga)- and 18Fluorine (18F)-targeted radioligands have been developed. PSMA PET/CT is used increasingly but there is limited data of its impact.  In this study patients with biochemical relapse of prostate cancer after surgery are randomised to the control or experimental group (1:2) and undergo a PSMA PET/CT scan. The experimental group receives individualised therapy based on the result of the PET/CT. The control group receives standard salvage therapy and the result of the PET/CT is blinded. The patients are followed-up with PSA test and quality of life questionnaires. 
Sponsor: Stefan Carlsson 
Intervention: Individualised therapy 
Start Date: 2018-10-30 
Last Updated: 2023-10-25 
Number of Patients: 450 
Recruitment Status: RECRUITING 
Condition: Prostate Cancer 

NCTID: NCT02102477

Title: Surgery Versus Radiotherapy for Locally Advanced Prostate Cancer 
Study Summary: This prospective, open randomized phase III surgical trial seeks to study whether radical prostatectomy (with or without the combination of external radiation) improves prostate-cancer specific survival in comparison with primary radiation treatment and hormonal treatment among patients diagnosed with locally advanced (T3) prostate cancer. Untreated or conservatively treated locally advanced prostate cancer is associated with high mortality. Modern curative treatment for advanced solid malign tumors include surgery and/or radiation plus attempted chemotherapy if available to achieve both local control and elimination of potential micro metastases. Whereas there is evidence that surgery can cure localized prostate cancer, there are no clinical trials of multi-modal treatment of locally advanced prostate cancer that includes surgical removal of the prostate.  One potential advantage of adding prostatectomy to the treatment of LAPC is that removing the prostate enables a full pathological assessment of the tumor characteristics and thus a better estimation of the risk of recurrence. Surgical treatment could thus reduce the numbers needed to treat with chemotherapy and radiation, and thus improve quality of life after treatment. In addition, evidence indicate that residual cancer in the prostate occurs in 25% after radiation treatment (56) and surgical removal of the prostate may improve survival beyond what can be achieved by radiation and ADT. On the other hand, patients treated with surgery, radiation and hormones will experience side effects of all three treatment modalities and might fare better if radiotherapy plus hormones can provide oncological control without prior surgery.  A randomized clinical trial comparing two multimodal treatment regimens of which one includes a radical prostatectomy is therefore warranted. 
Sponsor: Olof Akre 
Intervention: Prostatectomy/Surgery 
Start Date: 2014-10 
Last Updated: 2022-03-31 
Number of Patients: 1200 
Recruitment Status: RECRUITING 
Condition: Prostatic Neoplasms 

NCTID: NCT00937560

Title: A Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer 
Study Summary: This single arm study evaluated the efficacy and safety of first-line chemotherapy with carboplatin and dose-dense weekly paclitaxel plus bevacizumab (Avastin) in participants with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants received 6-8 3-week cycles of treatment with bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve (AUC) of 6 on day 1 of each cycle. Following combination chemotherapy, bevacizumab could be continued to be given as a monotherapy. 
Sponsor: Hoffmann-La Roche 
Intervention: Bevacizumab 
Start Date: 2009-06-25 
Last Updated: 2017-11-06 
Number of Patients: 190 
Recruitment Status: COMPLETED 
Condition: Ovarian Cancer 

NCTID: NCT02215577

Title: ALPPS Versus PVE/PL 
Study Summary: Study Title Comparison of two different models of liver growth stimulation in advanced colorectal liver metastatic disease, (LIGRO Trial) enabling liver resection  Methodology Scandinavian Multiple Center Randomized Registry Based Clinical Trial  Study duration The planned duration of study participation for an individual subject from inclusion to follow-up are 3 years  Primary investigator:  Per Sandstrom (Linköping)  Number of subjects 100 patients randomized in a 1:1 randomization  Diagnosis and main inclusion criteria Patients with colorectal liver metastasis requiring liver resection, but are not resectable in one step because of a future liver remnant/standardized total liver volume of < 30 % extrahepatic metastatic disease is not an exclusion criteria if they can be addressed surgically in the future  Overall goal To evaluate if the ALPPS approach is superior to PVE in enabling patients, primarily unresectable due to inadequate FLR, to be resected and reach an R0 situation with an acceptable level of complications and perioperative mortality.  To evaluate if the ALPPS approach increases the growth rate of the liver compared to portal embolization or portal ligation leading to a shorter treatment period.  In addition the investigators aim to study if ALPPS may reach these goals without detectable or improved differences in tumor activity (PFS and OS), but with a shorter recovery and a higher proportion of patients reaching R0.  Hypothesis A higher proportion of patients can be resected with ALPPS counted as rate resected compared to the previously established methods with portal ligation or embolization.  This increased resection rate will not reduce the R0 rate, or increase the rate of Clavien grade 4 complication or higher (H0).  The ALPPS approach will increase the growth rate compared to portal embolization/ligation measured one week after the primary intervention. 
Sponsor: Regionalt Cancercentrum Väst 
Intervention: In-situ split 
Start Date: 2014-06 
Last Updated: 2014-08-13 
Number of Patients: 100 
Recruitment Status: UNKNOWN 
Condition: Colorectal Cancer 

NCTID: NCT01969877

Title: A Study of Cisplatin Plus Radiotherapy Compared to Cetuximab Plus Radiotherapy in Locally Advanced Head and Neck Cancer. 
Study Summary: The primary endpoint in this study is to investigate if there is a difference in overall survival in patients with locally advanced head and neck cancer, randomized to either radiotherapy and cetuximab or radiotherapy and cisplatin. A second randomization is performed in patients with T3-T4 tumors; allocated radiotherapy either 68.0 Gy or 73.1 Gy. 
Sponsor: Lund University Hospital 
Intervention: cetuximab 
Start Date: 2013-11 
Last Updated: 2020-09-02 
Number of Patients: 298 
Recruitment Status: COMPLETED 
Condition: Locally Advanced Head and Neck Cancer 

NCTID: NCT02432846

Title: Intratumoral Vaccination With Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy vs Sunitinib Post-nephrectomy in Newly Diagnosed Metastatic Renal Cell Carcinoma (mRCC) 
Study Summary: The purpose of this study is to compare tumor response, progression free survival (PFS) and overall survival (OS) in newly diagnosed mRCC patients treated with Intuvax (INN: ilixadencel) pre-nephrectomy followed by Sunitinib post-nephrectomy vs Sunitinib post-nephrectomy patients. 
Sponsor: Mendus 
Intervention: Intuvax (INN: ilixadencel) 
Start Date: 2015-04 
Last Updated: 2022-08-22 
Number of Patients: 88 
Recruitment Status: COMPLETED 
Condition: Renal Cell Carcinoma, Metastatic 

NCTID: NCT02914873

Title: SPCG17: Prostate Cancer Active Surveillance Trigger Trial 
Study Summary: A large proportion of men with prostate cancer are overdiagnosed and overtreated mainly due to PSA testing. Active surveillance (AS) aims to reduce these harms by recommending curative treatment only when and if signs of tumor progression occur. There are however a number of uncertainties in AS, the most important being when to initiate treatment. The investigators are therefore starting a large randomized multicenter trial testing the safety of a standardized active surveillance protocol with specified triggers for repeat biopsies and initiation of curative treatment. The standardized protocol is compared with current practice for active surveillance. The primary aim of the study is to reduce overtreatment and subsequent side effects, without increasing the risk of disease progression or prostate cancer mortality. 
Sponsor: Uppsala University 
Intervention: Active surveillance 
Start Date: 2016-10 
Last Updated: 2022-12-16 
Number of Patients: 2000 
Recruitment Status: RECRUITING 
Condition: Prostate Cancer 

NCTID: NCT01974661

Title: Phase I Safety Study of Dendritic Cell Vaccine to Treat Patients With Hepatocellular Carcinoma 
Study Summary: The primary objective of this study is to answer the question “Is it possible to inject the COMBIG-DC vaccine in a hepatic tumor without getting unacceptable side effects”? 
Sponsor: Mendus 
Intervention: COMBIG-DC (ilixadencel) 
Start Date: 2013-10 
Last Updated: 2017-09-29 
Number of Patients: 18 
Recruitment Status: COMPLETED 
Condition: Hepatocellular Carcinoma 

NCTID: NCT02606461

Title: Selinexor in Advanced Liposarcoma 
Study Summary: This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 342 total patients will be randomized to study treatment (selinexor or placebo). 
Sponsor: Karyopharm Therapeutics Inc 
Intervention: Selinexor 
Start Date: 2016-01-04 
Last Updated: 2023-01-23 
Number of Patients: 342 
Recruitment Status: COMPLETED 
Condition: Dedifferentiated Liposarcoma 

NCTID: NCT01358877

Title: A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer 
Study Summary: This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG). 
Sponsor: Hoffmann-La Roche 
Intervention: 5-Fluorouracil 
Start Date: 2011-11-08 
Last Updated: 2023-10-04 
Number of Patients: 4804 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT04988295

Title: A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure 
Study Summary: The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data. 
Sponsor: Janssen Research & Development, LLC 
Intervention: Lazertinib 
Start Date: 2021-11-17 
Last Updated: 2023-11-08 
Number of Patients: 776 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Carcinoma, Non-Small-Cell Lung 

NCTID: NCT03879395

Title: Surgery for Gastrointestinal Metastases of Malignant Melanoma - a Single Center Retrospective Cohort Study 
Study Summary: The aim is to conduct a single centre retrospective study of all patients with stage IV melanoma that underwent surgery for metastases at Sahlgrenska University Hospital between 2010-01-01 and 2018-12-31. Pre- and postoperative data will be collected from digital medical records, the Swedish Cancer Registry, the Swedish Cause of Death Register as well as from the national Swedish cancer patient database (INCA). If needed, patient records will be collected from other hospitals. Results will be presented in written format as a summary and analysis of the characteristics of the cases operated on during the inclusion period.  The aim is to identify predictive and prognostic factors for outcome and complications in the surgical treatment of stage IV metastatic melanoma. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Abdominal surgery with metastasectomy 
Start Date: 2010-01-01 
Last Updated: 2020-07-07 
Number of Patients: 15 
Recruitment Status: COMPLETED 
Condition: Melanoma Stage Iv 

NCTID: NCT04185831

Title: A MolEcularly Guided Anti-Cancer Drug Off-Label Trial 
Study Summary: This is a prospective, open-label, non-randomized combined basket- and umbrella trial divided in two parts; a limited feasibility-oriented part 1 including 154 patients and 3 treatment cohorts and part 2 that will include an expanded cohort of patients and treatment cohorts. The overall aims of the study are to test the feasibility, safety and efficacy of comprehensive genomic profiling on fresh tumor biopsies as a basis for treatment decision making and to compare two different sequencing, bioinformatics and decision-making platforms (part 1). Also to evaluate the efficacy and safety of off-label treatment with cancer drugs in patients selected based on genomic biomarker matching. 
Sponsor: Uppsala University Hospital 
Intervention: Atezolizumab 
Start Date: 2020-10-20 
Last Updated: 2020-10-28 
Number of Patients: 154 
Recruitment Status: UNKNOWN 
Condition: Solid Tumor 

NCTID: NCT00002823

Title: Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer 
Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if combination chemotherapy given after surgery is more effective than surgery alone for non-small cell lung cancer.  PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy following surgery with that of surgery alone in treating patients who have stage I, stage II, or stage IIIA non-small cell lung cancer. 
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris 
Intervention: cisplatin 
Start Date: 1995-02 
Last Updated: 2013-03-28 
Number of Patients: 3300 
Recruitment Status: COMPLETED 
Condition: Lung Cancer 

NCTID: NCT04787523

Title: Rectrospect - a Retrospective Study of Treatment Response 
Study Summary: Biopisies from patients diagnosed with rectal cancer between 2007-2019 will be cut into 4-6 micrometer thin sections for morphology and immunostaining. Every section will be numbered with a code that is connected to the patients personal identification number and the code list will be kept separately from the biopsies in a password protected file on the Sahlgrenska University Hospital server.  Patient data and outcome regarding response to treatment will be collected from patient charts and the Swedish ColoRectal Cancer Registry, but all data will be numbered with the same code number and all results will be kept away from the code list. In order to achieve the stated aims, that is, to study how the molecular and cellular characteristics of the tumour and its surrounding microenvironment as well as the interaction of tumour cells and immune cells affect treatment response, several molecular and cellular techniques and assays may be applied. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Radiotherapy 
Start Date: 2020-10-01 
Last Updated: 2023-11-07 
Number of Patients: 170 
Recruitment Status: COMPLETED 
Condition: Rectal Neoplasms 

NCTID: NCT02106546

Title: Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer 
Study Summary: The purpose of this study is to evaluate the safety and efficacy of the addition of veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and paclitaxel in adults with advanced or metastatic squamous non-small cell lung cancer (NSCLC). 
Sponsor: AbbVie 
Intervention: Carboplatin 
Start Date: 2014-04-10 
Last Updated: 2020-11-17 
Number of Patients: 970 
Recruitment Status: COMPLETED 
Condition: Squamous Non-Small Cell Lung Cancer 

NCTID: NCT05009394

Title: Surgical Treatments for Postamputation Pain 
Study Summary: This is a double-blind randomised controlled trial (RCT) which compares the effectiveness of three surgical techniques for alleviating residual limb pain (RLP), neuroma pain and phantom limb pain (PLP). The three surgical treatments are Targeted Muscles Reinnervation (TMR), Regenerative Peripheral Nerve Interface (RPNI), and an active control (neuroma excision and muscle burying). Patients will be follow-up for 4 years. 
Sponsor: Center for Bionics and Pain Research 
Intervention: Targeted Muscle Reinnervation (TMR) 
Start Date: 2023-06-20 
Last Updated: 2023-09-29 
Number of Patients: 110 
Recruitment Status: RECRUITING 
Condition: Residual Limb Pain 

NCTID: NCT04043494

Title: International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma 
Study Summary: Primary objectives:  * Randomization R1, all patients eligible: To examine, whether the cumulative incidence of relapses with involvement of the CNS (CNS relapse, pCICR) can be decreased by a modified induction therapy including dexamethasone (experimental arm) instead of prednisone (standard arm) * Randomization R2, only patients with high risk LBL eligible: to examine, whether the probability of event-free survival (pEFS) in these patients can be improved by receiving an intensified treatment arm versus a standard treatment arm (as used in the EURO-LB 02) 
Sponsor: University Hospital Muenster 
Intervention: Cyclophosphamide 
Start Date: 2019-08-23 
Last Updated: 2022-12-16 
Number of Patients: 683 
Recruitment Status: RECRUITING 
Condition: Lymphoblastic Lymphoma, Childhood 

NCTID: NCT00017095

Title: Biomarker (p53 Gene) Analysis and Combination Chemotherapy Followed by Radiation Therapy and Surgery in Treating Women With Large Operable or Locally Advanced or Inflammatory Breast Cancer 
Study Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Currently patients with breast cancer are treated with one of several very similar combinations of drugs. Analysis of biomarkers in tumor tissue may help doctors predict how well patients with breast cancer will respond to treatment and help doctors choose the best drug regimen to treat each patient.  PURPOSE: This randomized phase III trial is studying giving different regimens of chemotherapy and comparing how well they work in treating women with large operable or locally advanced or inflammatory breast cancer. This study is also looking at whether analyzing a specific biomarker (p53) in tumor tissue may help doctors predict how well patients will respond to treatment and help doctors choose the best drug to treat each patient. 
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 
Intervention: filgrastim 
Start Date: 2001-03 
Last Updated: 2013-10-24 
Number of Patients: 1856 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT02244632

Title: Modufolin (Arfolitixorin) in Combination With 5-Fluorouracil Alone or Together With Oxaliplatin or Irinotecan in Colorectal Cancer 
Study Summary: The purpose is to characterise the tolerability of Modufolin (arfolitixorin) in combination with 5-FU alone, in combination with 5-FU and Oxaliplatin, in combination with 5-FU and Irinotecan and in combination with 5-FU, Oxaliplatin and Bevacizumab.  Another purpose is to investigate 4 doses of Modufolin to identify the best dose for further assessment. 
Sponsor: Isofol Medical AB 
Intervention: Modufolin (arfolitixorin) 
Start Date: 2014-09 
Last Updated: 2020-09-09 
Number of Patients: 105 
Recruitment Status: COMPLETED 
Condition: Colorectal Neoplasm 

NCTID: NCT02513394

Title: PALbociclib CoLlaborative Adjuvant Study 
Study Summary: This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC).  The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned. 
Sponsor: Alliance Foundation Trials, LLC. 
Intervention: Palbociclib 
Start Date: 2015-08 
Last Updated: 2023-06-15 
Number of Patients: 5796 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Breast Cancer 

NCTID: NCT00045032

Title: Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer 
Study Summary: The purpose of this trial is to evaluate Herceptin treatment for 1 year and 2 years (versus observation 

o Herceptin) in women with HER2-overexpressing primary breast cancer who have completed (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable. Efficacy and safety will be assessed for 10 years from randomization for each participant. All participants will continue to be followed for survival until 10 years after enrollment of the last participant.

Sponsor: Hoffmann-La Roche 
Intervention: Herceptin 
Start Date: 2001-11 
Last Updated: 2017-04-27 
Number of Patients: 5099 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT00866762

Title: A Study of the Efficacy of MK-0683 in Patients With Polycythaemia Vera and Essential Thrombocythaemia 
Study Summary: The aim of the present study is to evaluate the efficacy and safety of MK-0683 in the treatment of PV and ET. This agent has most recently been shown to be a potent inhibitor of the autonomous proliferation of haematopoietic cells of PV and ET patients carrying the JAK2 V617F mutation. Accordingly, it may be anticipated that MK-0683 - by decreasing the JAK2 allele burden - may influence clonal myeloproliferation and in vivo granulocyte, platelet and endothelial activation , which are considered to be major determinants of morbidity and mortality ( thrombosis, bleeding, extramedullary haematopoiesis , myelofibrosis ) in these disorders. The effects of MK-0683 at the molecular level will be studied by global/ focused gene expression profiling, epigenome profiling and proteomics. 
Sponsor: Copenhagen University Hospital at Herlev 
Intervention: HDAC inhibitor (MK-0683) 
Start Date: 2009-02 
Last Updated: 2011-12-12 
Number of Patients: 60 
Recruitment Status: UNKNOWN 
Condition: Polycythemia Vera 

NCTID: NCT02288962

Title: Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas 
Study Summary: Due to lack of hormone overproduction in non-functioning pituitary adenomas (NFPAs), only the symptomatic adenomas or large adenomas with proven growth and risk for symptoms in near future will undergo pituitary surgery. The remaining adenomas are monitored regularly. Operation of these large adenomas will rarely remove all tumour tissue, and there is also a risk of worsening of pituitary function. Often, adenomas with the highest growth potential are operated several times and some also need radiation therapy, providing additional risk for pituitary failure. Unlike some of the hormone-producing adenomas, there is no established pharmacological treatment for NFPAs. However, there are a few non-randomized studies suggesting that treatment with dopamine agonists may slow growth, and also induce tumour shrinkage. At present, cabergoline is the dopamine agonist most widely used in the treatment of pituitary adenomas secreting prolactin.  Aim is to study the effect of medical treatment with cabergoline in non-functioning pituitary adenomas on the change in tumour volume. 
Sponsor: St. Olavs Hospital 
Intervention: cabergoline 
Start Date: 2014-11 
Last Updated: 2023-01-20 
Number of Patients: 60 
Recruitment Status: RECRUITING 
Condition: Pituitary Neoplasms 

NCTID: NCT00553410

Title: Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer 
Study Summary: RATIONALE: Estrogen can cause the growth of breast cancer cells. Letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known which regimen of letrozole is more effective in postmenopausal women who have received hormone therapy for early-stage breast cancer.  PURPOSE: This randomized phase III trial is comparing two different regimens of letrozole in preventing cancer in postmenopausal women who have received 4-6 years of hormone therapy for hormone receptor-positive, lymph node-positive, early-stage breast cancer. 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: Letrozole 
Start Date: 2007-08 
Last Updated: 2020-03-11 
Number of Patients: 4884 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT03151772

Title: Bioavailability of Disulfiram and Metformin in Glioblastomas 
Study Summary: Neuro-oncological trials may fail due to the drug never getting to the intended target (i.e. within the tumor micro environment). Also, changes’ occurring in tumor cells when removed from patients and grown in-vitro is another limiting factor influencing the clinical success.  Important questions are therefore:  # Does the drug get there? # Does the drug do what it is intended to do?  To improve chances of clinical success there is a need for rational and intelligent selection of potential drugs in future trials. This is an initiative for analyzing tumor concentration of preoperative administered repurposed drugs 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Disulfiram 
Start Date: 2018-01-29 
Last Updated: 2020-09-28 
Number of Patients: 3 
Recruitment Status: TERMINATED 
Condition: Glioblastoma 

NCTID: NCT01572038

Title: A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer 
Study Summary: This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first. 
Sponsor: Hoffmann-La Roche 
Intervention: Docetaxel 
Start Date: 2012-06-01 
Last Updated: 2020-09-25 
Number of Patients: 1436 
Recruitment Status: COMPLETED 
Condition: Breast Neoplasms 

NCTID: NCT02799238

Title: Autologuos Lymphoid Effector Cells Specific Against Tumour (ALECSAT) as Add on to Standard of Care in Patients With Glioblastoma 
Study Summary: This is a randomised, open-label, multi-centre, Phase II study in patients with newly diagnosed glioblastoma.  62 patients with newly diagnosed glioblastoma are enrolled in the study in a 1:2 allocation (standard of care (SOC): ALECSAT as an adjunct therapy to SOC).  Patients recruited into this study will receive either:  * ALECSAT as an adjunct therapy to standard of care for newly diagnosed glioblastoma (first line therapy: Stupp regimen, followed by second line therapy at the Investigator’s discretion) or * Standard of care therapy for newly diagnosed glioblastoma (first line therapy: Stupp regimen, followed by second line therapy at the Investigator’s discretion). 
Sponsor: CytoVac A/S 
Intervention: ALECSAT 
Start Date: 2016-03 
Last Updated: 2020-04-30 
Number of Patients: 62 
Recruitment Status: COMPLETED 
Condition: Glioblastoma 

NCTID: NCT04722692

Title: Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ 
Study Summary: The trial aims to investigate the use of superparamagnetic iron oxide (SPIO) nanoparticles as a tracer for delayed sentinel lymph node dissection (d-SLND) in patients where upfront axillary surgery (SLND) is oncologically deemed unnecessary and should be avoided. This includes but is not limited to patients with a preoperative diagnosis of ductal cancer in situ of the breast (DCIS), an unclear BIRADS 4-5 planned for diagnostic excision or women planned for risk reducing mastectomy. SPIO is injected in the primary operation, and should final specimen pathology demonstrate invasive breast cancer, only then is an operation in the axilla (d-SLND) performed. 
Sponsor: Uppsala University 
Intervention: Delayed SLND 
Start Date: 2020-03-01 
Last Updated: 2023-08-03 
Number of Patients: 500 
Recruitment Status: RECRUITING 
Condition: DCIS 

NCTID: NCT00957125

Title: A Translational Trial on Molecular Markers and Functional Imaging to Predict Response of Preoperative Treatment of Breast Cancer Early 
Study Summary: Patients with localized primary breast cancer including inflammatory breast cancer suitable for primary medical treatment and/or regional lymph node metastases receive six cycles of chemotherapy with epirubicin and docetaxel. Treatment evaluations are performed after the second, fourth and sixth cycle. In case of SD/PR after the second course, bevacizumab is added to the combination for the remaining four courses.  Besides standard response evaluation clinically and by mammography and ultrasound, several functional imaging techniques including MR, CT-PET and contrast-enhanced ultrasound are investigated. Fresh tumor tissue samples from the primary tumor are collected before start, after two courses and in connection with surgery. The aim of the trial is to detect biological factors and functional imaging techniques with the ability to predict response at an early stage of treatment. 
Sponsor: Thomas Hatschek 
Intervention: Epirubicin 
Start Date: 2008-09 
Last Updated: 2016-09-08 
Number of Patients: 151 
Recruitment Status: UNKNOWN 
Condition: Breast Cancer 

NCTID: NCT04928846

Title: A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC) 
Study Summary: Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. Change in disease activity and adverse events will be assessed.  Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of Teliso-V or Docetax at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 698 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 250 sites worldwide.  Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria.  There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. 
Sponsor: AbbVie 
Intervention: Telisotuzumab Vedotin 
Start Date: 2022-03-25 
Last Updated: 2023-11-27 
Number of Patients: 698 
Recruitment Status: RECRUITING 
Condition: Non Small Cell Lung Cancer 

NCTID: NCT01456078

Title: A Multicenter Study Evaluating Efficacy and Safety of 177Lu-DOTA-TATE Based on Kidney-Dosimetry in Patients With Disseminated Neuroendocrine Tumors 
Study Summary: By improved kidney dosimetry including biological effective dose and taking into account potential risk factors (especially for kidney toxicity), it might be possible to give an optimal and personalized treatment with 177Lu-DOTA-TATE to the patient with metastatic neuroendocrine tumor. 
Sponsor: Lund University Hospital 
Intervention: 177Lu-DOTA-TATE 
Start Date: 2011-10 
Last Updated: 2019-09-30 
Number of Patients: 60 
Recruitment Status: COMPLETED 
Condition: Neuroendocrine Tumors 

NCTID: NCT02312258

Title: A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT) 
Study Summary: The purpose of this study is to determine the effect of ixazomib maintenance therapy on progression free survival (PFS) compared with placebo, in participants with NDMM who have had a major response (complete response <math display="block">CR</math>, very good partial response <math display="block">VGPR</math>, or partial response <math display="block">PR</math>) to initial therapy and who have not undergone SCT. 
Sponsor: Takeda 
Intervention: Placebo 
Start Date: 2015-04-09 
Last Updated: 2023-09-21 
Number of Patients: 706 
Recruitment Status: COMPLETED 
Condition: Multiple Myeloma 

NCTID: NCT05933577

Title: A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001) 
Study Summary: The purpose of this study is to learn if V940 which is an individualized neoantigen therapy (INT; formerly, called messenger ribonucleic acid <math display="block">mRNA</math>-4157) with pembrolizumab (MK-3475) is safe and prevents cancer from returning in people with high-risk melanoma. Researchers want to know if V940 with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: V940 
Start Date: 2023-07-19 
Last Updated: 2023-11-24 
Number of Patients: 1089 
Recruitment Status: RECRUITING 
Condition: Melanoma 

NCTID: NCT04404777

Title: Local Recurrence Due to Rectal Cancer in Sweden 
Study Summary: The aim of this retrospective national registry study is to validate the reporting of local recurrence in the registry. Another aim is to identify preoperative risk factors for local recurrence. This can in turn indicate the need for a more intense follow-up. The treatment of local recurrence, including the impact of the multidisciplinary team conference (MDT) and the surgical procedure and the referral pathways of local recurrences will also be determined.  We aim to evaluate treatment outcome after local recurrence for patients operated or treated between 2007-2018. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Treatment for local recurrence with surgery or other treatments 
Start Date: 2022-07-01 
Last Updated: 2023-11-07 
Number of Patients: 12000 
Recruitment Status: RECRUITING 
Condition: Rectal Neoplasms 

NCTID: NCT03074110

Title: Isocapnic Hyperventilation - an Alternative Method 
Study Summary: Isocapnic hyperventilation (IHV) is a method that shortens time to extubation after inhalation anaesthesia by increasing airway carbon dioxide (CO2) during hyperventilation (HV). In two experimental studies (mechanical lung model and porcine model) and in a pilot study on patients undergoing sevoflurane anaesthesia for major ear-nose-throat (ENT) surgery, the investigators evaluated the feasibility of an alternative technique of IHV. By performing a prospective, randomised controlled study, the investigators want to further test this alternative method for IHV. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Isocapnic hyperventilation 
Start Date: 2016-11-11 
Last Updated: 2018-01-02 
Number of Patients: 31 
Recruitment Status: COMPLETED 
Condition: Oropharyngeal Neoplasms 

NCTID: NCT04147780

Title: Sentinel Node Extended in Squamous Cell Vulvar Cancer 
Study Summary: The aim of this study is to investigate the feasibility of sentinel node biopsy in patients with squamous cell vulvar cancer, currently not regarded suitable for the sentinel node technique, i.e. patients with tumors ≥4cm, multifocal tumors or locally recurrent disease. A positive result of this pilot study might constitute the basis for a future full-scale multinational trial. 
Sponsor: Diana Zach 
Intervention: Sentinel node biopsy 
Start Date: 2019-12-14 
Last Updated: 2023-11-01 
Number of Patients: 64 
Recruitment Status: COMPLETED 
Condition: Vulva Cancer 

NCTID: NCT04067180

Title: Randomized Clinical Study Assessing Haplo vs. URD in AML 
Study Summary: This study compares haplo-identical family donor stem cell transplantation (haplo SCT) to matched unrelated donor transplantation (URD SCT) in adult patients with acute myeloid leukemia (AML) with the hypothesis that haplo SCT is as good as URD SCT.  Background:  A haplo-identical family donor is a relative sharing 50% of the human leukocyte antigens (HLA) of the patient. SCT with this type of donor is increasing, and a number of retrospective studies have demonstrated its feasibility, but prospective randomized studies are still lacking. Such studies are necessary to establish the benefits of haplo SCT. For the ≈70% of the patients that lack the 1st choice donor, an HLA-matched sibling, the 2nd choice is an URD at most centers. However, if haplo-identical donors are as good as URDs, this could change. Haplo-identical donors have several advantages. Almost all patients have at least one available haplo-identical donor, while URDs can be difficult to find. It also eliminates the need for time-consuming donor searches, and is considerably less costly.  The Study:  Patients can be included in the study if they have AML and require SCT, ≥18 years, DO NOT have an HLA-matched sibling donor, and DO have potential haplo-identical family donors AND URDs.  After enrollment in the study, the patients are assigned randomly to either haplo SCT or URD SCT. The treatment surrounding the transplantation differs according to the donor type. Patients receiving haplo-identical transplantation are treated with a specified chemotherapy protocol before transplantation and a chemotherapy combined with immunosuppressive drugs after the transplantation to prevent graft-vs. host disease (GVHD). The patients receiving URD SCT will be treated according to the standard protocol at their center. Thus, haplo SCT will be compared to what is currently used in patients without an HLA-identical sibling today.  The primary endpoint of this study is graft-vs.-host disease- and relapse free survival two years after study inclusion. This measurement takes into account the side effect that causes the most long-term suffering, graft-vs-host disease, as well as leukemia relapse and thus indicates to what extent the treated patients remain relapse-free and without significant side effects. Secondary end points include relapse-free survival, frequencies of graft-versus-host disease and of infections, and the patients will be followed in the study for five years. 
Sponsor: Karolinska Institutet 
Intervention: allogeneic stem cell transplantation with a haplo-identical family donor graft 
Start Date: 2019-11-12 
Last Updated: 2023-04-05 
Number of Patients: 18 
Recruitment Status: TERMINATED 
Condition: Acute Myeloid Leukemia 

NCTID: NCT03262935

Title: SYD985 vs. Physician’s Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer 
Study Summary: The purpose of this study is to demonstrate that SYD985 <math display="block">(vic-)trastuzumab duocarmazine</math> is superior to physician’s choice in prolonging progression free survival. 
Sponsor: Byondis B.V. 
Intervention: (vic-)trastuzumab duocarmazine 
Start Date: 2017-12-15 
Last Updated: 2023-10-19 
Number of Patients: 437 
Recruitment Status: COMPLETED 
Condition: Metastatic Breast Cancer 

NCTID: NCT04933695

Title: A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment 
Study Summary: The main objective of this study is to evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in participants who receive sotorasib at either 960 mg daily or 240 mg daily whose tumors are programmed death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) < 1% and/or harbor a serine/threonine kinase 11 (STK11) co-mutation, in a subgroup of participants with PD-L1 < 1% and in a subgroup of participants with STK11 co-mutation. 
Sponsor: Amgen 
Intervention: Sotorasib 
Start Date: 2022-01-28 
Last Updated: 2023-10-11 
Number of Patients: 42 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Non-small Cell Lung Cancer 

NCTID: NCT02256228

Title: Intra-Peritoneal Local Anaesthesia After Cytoreductive Surgery 
Study Summary: Can perioperative administration of intra-peritoneal local anaesthetics further reduce postoperative pain, inflammation and outcome in patients undergoing major abdominal surgery (cytoreductive surgery) and managed with thoracic epidural analgesia? - Multicenter study. 
Sponsor: Göteborg University 
Intervention: Ropivacaine 
Start Date: 2014-10 
Last Updated: 2019-01-15 
Number of Patients: 40 
Recruitment Status: COMPLETED 
Condition: Pain 

NCTID: NCT01734928

Title: Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma 
Study Summary: The purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is compared to the combination of bortezomib and low dose dexamethasone. 
Sponsor: Celgene 
Intervention: Pomalidomide 
Start Date: 2013-01-07 
Last Updated: 2023-06-06 
Number of Patients: 559 
Recruitment Status: COMPLETED 
Condition: Multiple Myeloma 

NCTID: NCT00002528

Title: Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer 
Study Summary: RATIONALE: Removing axillary lymph nodes may be effective in stopping the spread of breast cancer cells. It is not yet known if surgery to remove breast cancer is more effective with or without lymph node removal.  PURPOSE: Randomized phase III trial to compare the effectiveness of breast surgery with or without removal of axillary lymph nodes in treating women who have stage I or stage IIA breast cancer. 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: tamoxifen citrate 
Start Date: 1993-05 
Last Updated: 2013-04-04 
Number of Patients: 473 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT05293041

Title: Argipressin’s Influence on Blood Loss During Hepatic Resection 
Study Summary: Infusion of Argipressin during hepatic resection surgery may reduce blood loss. It may also reduce transfusion requirements, and mitigate the perioperative inflammatory response compared to placebo. Subjects will be randomized to infusion of Argipressin or placebo during surgery. Blood loss, transfusion requirements, surgical data including length of stay in hsopital, inflammatory markers and markers of renal- intestinal- and cardiac injury will be assessed. 
Sponsor: Kristina Svennerholm 
Intervention: Argipressin 
Start Date: 2022-03-27 
Last Updated: 2023-07-13 
Number of Patients: 248 
Recruitment Status: RECRUITING 
Condition: Colon Cancer Liver Metastasis 

NCTID: NCT02959541

Title: PK/PD Investigation of Calciumfolinat in Blood, Tumor and Adjacent Mucosa in Patient With Colon Cancer 
Study Summary: This is an open randomized single site Pharmacokinetic and Pharmacodynamic study,of Calciumfolinat 60 mg/m², 200 mg/m² or 500 mg/ m² in blood, tumor and adjacent mucosa from patients with colon cancer 
Sponsor: Vastra Gotaland Region 
Intervention: Leucovorin 
Start Date: 2016-09 
Last Updated: 2022-06-13 
Number of Patients: 48 
Recruitment Status: UNKNOWN 
Condition: Colon Cancer 

NCTID: NCT05020236

Title: MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma 
Study Summary: The purpose of this study is to evaluate whether the BCMA-CD3 bispecific antibody elranatamab, alone and/or in combination with the anti-CD38 monoclonal antibody, daratumumab, can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone. People with multiple myeloma who have received previous treatment including lenalidomide and a proteasome inhibitor will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will compare the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab compared to daratumumab, pomalidomide, and dexamethasone. Part 3 of the study will evaluate an alternative dosing schedule of elranatamab in combination with daratumumab. Participants in all parts of the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study. 
Sponsor: Pfizer 
Intervention: Elranatamab 
Start Date: 2021-10-04 
Last Updated: 2023-08-24 
Number of Patients: 854 
Recruitment Status: RECRUITING 
Condition: Multiple Myeloma 

NCTID: NCT04173494

Title: A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM) 
Study Summary: MOMENTUM is a randomized, double-blind, active control Phase 3 trial intended to confirm the differentiated clinical benefits of the investigational drug momelotinib (MMB) versus danazol (DAN) in symptomatic and anemic participants who have previously received an approved Janus kinase inhibitor (JAKi) therapy for myelofibrosis (MF). The purpose of this clinical study is to compare the effectiveness and safety of MMB to DAN in treating and reducing: 1) disease related symptoms, 2) the need for blood transfusions and 3) splenomegaly, in adults with primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF. The study is planned in countries including, but not limited to: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom (UK) and United States (US).  Participants must be symptomatic with a Myelofibrosis Symptom Assessment Form (MFSAF) version (v) 4.0 Total Symptom Score of >= 10 at screening, and be anemic with hemoglobin (Hgb) < 10 gram/deciliter (g/dL). For participants with ongoing JAKi therapy at screening, JAKi therapy must be tapered over a period of at least 1 week, followed by a 2-week non-treatment washout interval prior to randomization.  Participants will be randomized 2:1 to orally self-administer blinded treatment: MMB plus placebo or DAN plus placebo. Participants randomized to receive MMB who complete the randomized treatment period to the end of Week 24 may continue to receive MMB in the open-label extended treatment period to the end of Week 204 (a total period of treatment of approximately 4 years) if the participants tolerates and continues to benefit from MMB.  Participants randomized to receive DAN may cross-over to MMB open-label treatment in the following circumstances: at the end of Week 24 if they complete the randomized treatment period; or at the end of Week 24 if they discontinue treatment with DAN but continue study assessments and do not receive prohibited medications including alternative active anti-MF therapy; or at any time during the randomized treatment period if they meet the protocol-defined criteria for radiographically confirmed symptomatic splenic progression. Participants randomized to receive DAN who are receiving clinical benefit at the end of Week 24 may choose to continue DAN therapy up to Week 48. The comparator treatment, DAN, is an approved medication in the US and in some other countries and is recommended by national guidelines as a treatment for anemia in MF. 
Sponsor: Sierra Oncology LLC - a GSK company 
Intervention: Momelotinib 
Start Date: 2020-02-07 
Last Updated: 2023-11-01 
Number of Patients: 195 
Recruitment Status: COMPLETED 
Condition: Primary Myelofibrosis 

NCTID: NCT04129502

Title: TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations 
Study Summary: The purpose of this study is to compare the effectiveness of TAK-788 as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors has epidermal growth factor receptor (EGFR) exon 20 insertion mutations.  Participants will be randomly assigned to one of the two treatment groups- TAK-788 group or Platinum-based chemotherapy group.  Participants will receive TAK-788 orally and pemetrexed/cisplatin or pemetrexed/carboplatin via vein until the participants experience worsening disease (PD) as assessed by blinded independent review committee (IRC), intolerable harmful effects or another discontinuation criteria. 
Sponsor: Takeda 
Intervention: TAK-788 
Start Date: 2020-01-10 
Last Updated: 2023-04-07 
Number of Patients: 354 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) 

NCTID: NCT00717938

Title: A Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer 
Study Summary: The endpoint is to investigate if the addition of low molecular heparin - enoxaparin, will result in a significant increase of overall survival in patients with small cell lung cancer, receiving standard chemotherapy. 
Sponsor: Lund University Hospital 
Intervention: cisplatinum or carboplatin and e.g.etoposide. 
Start Date: 2008-06 
Last Updated: 2017-08-25 
Number of Patients: 390 
Recruitment Status: COMPLETED 
Condition: Small Cell Lung Cancer 

NCTID: NCT01319162

Title: Prevalence of Polycystic Ovary Syndrome (PCOS) in Obese Premenopausal Women 
Study Summary: Between 40% and 85% of women with Polycystic Ovary Syndrome (PCOS) are overweight or obese and obesity is closely linked to the development of PCOS. Although it is well established that obesity increases the severity of the clinical features of PCOS, data regarding the prevalence of PCOS in obese women and the change in body weight in women with PCOS over time are scares. In a prevalence study it was investigated whether obesity increases the risk of PCOS in the general population and they demonstrated that the prevalence rate of PCOS in underweight, normal-weight, overweight, and obese women were 8.2, 9.8, 9.9, and 9.0%, respectively, similar to that observed in the general population. These results suggest that the risk of PCOS is only minimally increased with obesity. On the other hand, in a Spanish prevalence study among overweight and obese subjects, they demonstrated a 28.3% prevalence of PCOS, which is markedly higher compared with the 5.5% prevalence of PCOS in lean women in Spain.  First the investigators aim to estimate the prevalence/probability of PCOS among obese, premenopausal women (between 18 and 50 years) with no symptoms of classic menopausal symptoms in Sweden. Secondly, to elucidate whether women diagnosed with PCOS respond to standard weight reduction regime to the same extent as women without PCOS. 
Sponsor: Göteborg University 
Intervention: Weight reduction regimen 
Start Date: 2011-03-30 
Last Updated: 2017-03-16 
Number of Patients: 300 
Recruitment Status: COMPLETED 
Condition: Polycystic Ovary Syndrome 

NCTID: NCT02560662

Title: PhysSurg-B : Physical Activity in Relation to Surgical Operations - Breast Cancer 
Study Summary: The purpose of this study is to investigate whether a training program with intensified physical exercise prior to and after surgery for breast cancer enhances postoperative recovery. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Physical activity 
Start Date: 2016-01-27 
Last Updated: 2020-10-22 
Number of Patients: 400 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT01681472

Title: PK/PD Investigation of Modufolin (Arfolitixorin) in Plasma, Tumor and Adjacent Mucosa Adjacent Mucosa in Patients With Colon Cancer 
Study Summary: The purpose of this study is to compare the concentration of four different metabolites in the tumor, in adjacent mucosa and in plasma in patients with colon cancer receiving two different doses of Modufolin (arfolitixorin) and Levoleucovorin (Isovorin®), respectively (60 and 200 mg/m2). 
Sponsor: Isofol Medical AB 
Intervention: 6R-MTHF (arfolitixorin) 200 mg/m2 
Start Date: 2012-09 
Last Updated: 2020-09-25 
Number of Patients: 32 
Recruitment Status: COMPLETED 
Condition: Colonic Neoplasms 

NCTID: NCT04358328

Title: Effect of CGA for Frail Elderly Patients Operated for Colorectal Cancer - The CRC Frailty-study 
Study Summary: This multicentre randomized controlled trial aims to investigate whether an individualized comprehensive geriatric assessment (CGA) and care will improve postoperative results in frail elderly patients undergoing surgery for colorectal cancer. The study will take place in departments applying the ERAS-concept which is considered gold standard in colorectal surgery. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Comprehensive geriatric assessment (CGA) and care 
Start Date: 2020-10-01 
Last Updated: 2022-11-01 
Number of Patients: 340 
Recruitment Status: RECRUITING 
Condition: Colorectal Neoplasms 

NCTID: NCT00818623

Title: Investigation of a New Trial Drug (FE200486) in Prostate Cancer Patients 
Study Summary: The purpose of this trial was to find an optimal dose for a new trial drug - degarelix (FE200486) - in the treatment of prostate cancer. Furthermore the safety of the drug was studied. Patients participating were treated with FE200486 on one occasion. Thereafter they came in for visits following a specific schedule until blood samples showed that there was no further effect. 
Sponsor: Ferring Pharmaceuticals 
Intervention: Degarelix 
Start Date: 2002-11 
Last Updated: 2011-05-23 
Number of Patients: 172 
Recruitment Status: COMPLETED 
Condition: Prostate Cancer 

NCTID: NCT05239728

Title: A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022) 
Study Summary: The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy.  The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS). 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Belzutifan 
Start Date: 2022-03-15 
Last Updated: 2023-11-28 
Number of Patients: 1800 
Recruitment Status: RECRUITING 
Condition: Carcinoma, Renal Cell 

NCTID: NCT04608318

Title: Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (CLL) 
Study Summary: The aim of this study is to compare the efficacy of continuous ibrutinib monotherapy with fixed-duration venetoclax plus obinutuzumab and fixed-duration ibrutinib plus venetoclax by measuring progression-free survival (PFS) in patients with previously untreated CLL. 
Sponsor: German CLL Study Group 
Intervention: Ibrutinib 
Start Date: 2021-03-01 
Last Updated: 2023-02-23 
Number of Patients: 897 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Chronic Lymphoid Leukemia 

NCTID: NCT03793478

Title: Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood 
Study Summary: Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research.  Children or young adults with a certain kind of blood cancer (FLT3-ITD AML) might be able to join this study if it has come back after remission or is not responding to treatment. 
Sponsor: Daiichi Sankyo, Inc. 
Intervention: Quizartinib 
Start Date: 2018-08-15 
Last Updated: 2023-10-13 
Number of Patients: 65 
Recruitment Status: RECRUITING 
Condition: Acute Myeloid Leukemia 

NCTID: NCT02049632

Title: Sentinel Node Biopsy in Breast Cancner: Omission of Axillary Clearance After Micrometastasis 
Study Summary: Sentinel node (SN) biopsy in breast cancer has been demonstrated to be a reliable method, and several follow-up studies have shown that it is safe to refrain from completion axillary clearance (axillary lymph node dissection, ALND) in SN-negative patients. SN biopsy alone results in significantly less arm discomfort following the operation.  However, as a surprisingly low frequency of axillary relapse has been observed in patients without any axillary intervention (neither SN biopsy nor axillary clearance), or without completion ALND after a positive SN biopsy, the importance of ALND is being questioned, even for patients with SN metastases. A large, randomized study (ISBCG23-1) was not able to show any differences in 5-year disease-free survival between patients with SN micrometastases who had undergone ALND and those who had not.  This Swedish multicenter study will include patients with SN micrometastases. These women will not undergo ALND but will be registered in a study cohort. The patients will otherwise be treated in accordance with the national guidelines and will be clinically followed every year for five years, after 10 years and finally after 15 years. Hypothesis: To refrain from axillary clearance in breast cancer patients with sentinel node micrometastases does not impair survival. 
Sponsor: Karolinska Institutet 
Intervention: Omission of axillary clearance 
Start Date: 2013-12 
Last Updated: 2023-03-10 
Number of Patients: 805 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT05328258

Title: Use of GnRHa During Chemotherapy for Fertility Protection 
Study Summary: Many cytotoxic drugs may harm the fertility of young women treated for cancer. The aim of the study is to investigate if the Gonadotropin-Releasing Hormone agonist (GnRHa) during cancer treatment can preserve the fertility of young female cancer subjects.  Approximately 300 women with newly diagnosed breast cancer and up to 200 women with newly diagnosed lymphoma, acute leukemias or sarcomas will be recruited before start of cancer treatment.  The patients will be randomised in between treatment with triptorelin (experimental) or placebo (control) intramuscularly a 1:1 ratio during chemotherapy. The injections may be given once monthly or once three months depending on type of chemotherapy given. Randomisation and study drug is blinded, neither investigator, research nurse nor patient will know if it is active drug or placebo. The only person who knows is the nurse preparing the injection.  Patients will be followed up to 5 years after end of treatment with physical examinations, vital signs, biochemical markers, bone mineral density exams, ultrasound for antral follicle counts and ovarian doppler flow, concomitant medications, adverse events and quality of life questionnaires. 
Sponsor: Kenny Rodriguez-Wallberg 
Intervention: Triptorelin Embonate 
Start Date: 2023-03-31 
Last Updated: 2023-10-27 
Number of Patients: 500 
Recruitment Status: RECRUITING 
Condition: Breast Cancer Female 

NCTID: NCT03664258

Title: A Multi-National Study In Bladder Cancer Patients to Detect Recurrences After TURB (Trans-urethral Resection of the Bladder) Earlier With the Xpert Bladder Cancer Monitor Assay (ANTICIPATE X) 
Study Summary: Bladder cancer is the 5th most common cancer in Europe, with more than 151,000 new cases diagnosed in 2012 (4% of the total). Bladder cancer has the highest recurrence rate of any malignancy, often as high as 70% within 5 years of successful treatment. This high recurrence rate requires diligent and accurate monitoring as a means for early diagnosis and treatment. Considering the burden associated to repeated invasive cystoscopies, there is a need for robust but accurate tests for surveillance. In that prospect, urinary molecular tests have been developed although none were deemed adequate in the European clinical guidelines to replace cystoscopies. The Xpert Bladder Cancer Monitor Assay is a qualitative in vitro diagnostic test designed to monitor for the recurrence of bladder cancer in patients previously diagnosed with this cancer. The test provides a fast and accurate result, is non-invasive and easy to perform. The aim of this study is to assess the non-inferiority of the Xpert Bladder Cancer Monitor assay in detecting recurrences in comparison to cystoscopy in the follow-up of patients with low or intermediate risk non-muscle-invasive bladder cancer (NMIBC). 
Sponsor: Cepheid 
Intervention: Xpert Bladder Cancer Monitor 
Start Date: 2018-06-06 
Last Updated: 2023-02-13 
Number of Patients: 852 
Recruitment Status: COMPLETED 
Condition: Non-muscle-invasive Bladder Cancer 

NCTID: NCT03511664

Title: Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer 
Study Summary: The primary objective of this study was to compare the two alternate primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) in patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who received 177Lu-PSMA-617 in addition to best supportive/best standard of care (BSC/BSoC) versus patients treated with best supportive/best standard of care alone. 
Sponsor: Endocyte 
Intervention: 177Lu-PSMA-617 
Start Date: 2018-05-29 
Last Updated: 2023-10-12 
Number of Patients: 831 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Prostate Cancer 

NCTID: NCT03867084

Title: Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma (HCC) and Complete Radiological Response After Surgical Resection or Local Ablation (MK-3475-937 / KEYNOTE-937) 
Study Summary: This study will evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) and complete radiological response after surgical resection or local ablation. The primary hypotheses of this study are that adjuvant pembrolizumab is superior to placebo with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) overall survival (OS). 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: Pembrolizumab 
Start Date: 2019-05-28 
Last Updated: 2023-09-08 
Number of Patients: 950 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Hepatocellular Carcinoma 

NCTID: NCT03911128

Title: A Treatment Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia 
Study Summary: The pilot study collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new platform protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised trials included in the study-design.  The pilot study is implemented as a master protocol without study specific interventions, thus as an observational study. The pilot study is for countries/study-groups who intend to join ALLTogether1 (including experimental interventions). For these countries the pilot study is crucial to optimise diagnostics, registration systems, collaborations with vendors, logistics and data-checks before starting the main study.  The study only includes “standard of care” treatment included in the master protocol. 
Sponsor: Mats Heyman 
Intervention: Observational 
Start Date: 2019-08-29 
Last Updated: 2023-08-30 
Number of Patients: 500 
Recruitment Status: RECRUITING 
Condition: Leukemia, Acute Lymphoblastic 

NCTID: NCT02858258

Title: ASCT After a Rituximab/Ibrutinib/Ara-c Containing iNduction in Generalized Mantle Cell Lymphoma 
Study Summary: The primary objective of the the trial is to establish one of three study arms, as future standard based on the comparison of the investigator-assessed failure-free survival. 
Sponsor: Prof. Dr. M. Dreyling (co-chairman) 
Intervention: R-CHOP/R-DHAP 
Start Date: 2016-07 
Last Updated: 2017-12-19 
Number of Patients: 870 
Recruitment Status: RECRUITING 
Condition: Mantle Cell Lymphoma 

NCTID: NCT05572801

Title: NOAC9 - Circulating Tumor DNA Guided Follow-Up in Anal Cancer 
Study Summary: This study investigates if circulating tumor DNA can improve the detection of early treatment failure or recurrence in localized squamous cell carcinoma of the anus (SCCA) after curative chemoradiotherapy thereby increasing the potential for cure. This will be done by comparing the standard follow-up program with ctDNA guided imaging follow-up. Secondly, the aim is to establish early interventions against late morbidities. 
Sponsor: Aarhus University Hospital 
Intervention: AMR B: HPV positive ctDNA guided imaging in follow-up 
Start Date: 2022-10-01 
Last Updated: 2022-10-10 
Number of Patients: 400 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Anal Cancer 

NCTID: NCT03119857

Title: Early Rising PSA Endocrine Treatment Versus Chemo-endocrine Therapy- SPCG14 
Study Summary: Summary  In patients with prostate cancer (PC) who have only biochemically relapsed disease after curative treatment (or some locally advanced PC patients), hormonal therapy remains a de facto standard of care treatment. Adding docetaxel-based chemotherapy to a standard-of-care hormonal therapy has an increased potential to treat prostate cancer cell clones resistant to androgen withdrawal and to possibly shorten the duration of therapy needed to control the disease.  This clinical trial is designed on the basis of an unmet clinical need, as well as other factors including: 1) a consensus among investigators on endpoints for studies of patients with a rising PSA, 2) the ability to identify subjects at high risk for developing radiographic metastases, 3) the fact that hormonal therapy has already been shown to improve survival when applied early in the natural history, and 4) the availability of chemotherapy such as docetaxel that can improve survival in subjects with advanced disease.  It is our hypothesis that a more appropriate group of patients who may benefit from the curative potential of systemic chemo-hormonal modality is that with minimal, but detectable disease who have a high probability of developing metastatic disease, clinical symptoms and eventually death from prostate cancer in a defined time frame. The investigators hypothesize further that the approach is likely to be more effective at a time of minimal tumour burden, resulting in minimization of the overall burden of therapy and better quality of life while on treatment.  This trial will determine whether any benefit is gained by adding chemotherapy to hormonal therapy alone in the population of subjects with a rising PSA. Two therapeutic approaches will be compared in this two-arm randomized clinical trial. The control Arm A provides antiandrogen (bicalutamide 150 mg x 1) alone. The experimental Arm B involves treatment with docetaxel for 8-10 cycles and antiandrogen (bicalutamide 150 mg x 1) treatment. For the schematic representation of study design please see Section 7.3.1.  Subjects with a rising PSA following definitive local curative therapy will be eligible, if their PSA doubling time is < 12 months. Also PC patients planned for anti-.androgen therapy are eligible, with the same criteria. Subjects with radiographic metastases will be excluded. The primary endpoint of the trial is progression-free survival of subjects that do not experience biochemical failure at 60 months from the start of therapy.  Based on the yearly number of prostate cancer patients who undergo definitive local therapies and the estimated probabilities of relapse, upwards of 400 men (if +15% improvement) in the Scandinavian countries are potential candidates for this approach. 
Sponsor: Göteborg University 
Intervention: Antiandrogen 
Start Date: 2009-02 
Last Updated: 2021-08-18 
Number of Patients: 349 
Recruitment Status: UNKNOWN 
Condition: Prostatic Neoplasms 

NCTID: NCT05519098

Title: COLO-SW-1 Pivotal Clinical Investigation 
Study Summary: The Clinical Investigation is a summative usability study and a ‘first-in-patient’-study of the independent medical device software (MDSW) utilizing artificial intelligence. The MDSW has completed the development phase and is ready to enter production. The primary objective of this study is to assess the user safety and secondary the user-friendliness of the MDSW to confirm compliance to certain General safety and performance requirements (GSPR) set by the MDR. The software to assess will be installed in a medical grade PC to allow the use of the MDSW according to its intended purpose of detecting colorectal polyps. However, the PC is not a part of the medical device under investigation and its performance and safety will not be assessed by this investigation. The intended purpose and clinical benefit of the MDSW is to assist the endoscopist in detecting more polyps, with the possibility of subsequently preventing colorectal cancer later on. The data obtained from the investigation will be used for regulatory purposes aiming to obtain a CE certification as class IIa according to MDR for the MDSW under investigation.  The multi-center investigation will assess 8-20 endoscopists experience with the MDSW and whether technical difficulties occur during its use in one site. The user experience of the endoscopists will be collected in a questionnaire form. The investigator will additionally record any possible adverse effects (AE) or adverse technical effects (ATE) of the use of the MDSW. The MDSW will be used during ordinary colonoscopy in adult, out-patients ≥18 years but variables related to the patient outcome will not be assessed. Patients with inadequate bowel preparation, active inflammation, cecum not reached or not consenting will be excluded from the study. Each endoscopist will assess the device during 3-5 patient examinations.  The primary objective of the investigation is to confirm that COLO-SW-1 is safe for use during colonoscopy as intended for aiding in detection of polyps. The secondary objective is to assess the user-friendliness of the MDSW interface.  The clinical investigation is estimated to start in August 2022. The participation of the endoscopists will take place continuously through the clinical investigation until required number (up to 20) of participants has been reached. When 8 participants have been included in total, an interim analysis is made, and the Principal Investigator decides if the confirmatory objectives have been met. A conclusion can be drawn from the partial objectives met at this point. The study can continue for up to 20 participants to complete all endpoints, if required. The investigation will be closed by end of October 2022. The investigation will be deemed completed once the last evaluation form has been completed by the endoscopists. 
Sponsor: Augere Medical AS 
Intervention: COLO-SW-1 
Start Date: 2022-08-23 
Last Updated: 2022-12-16 
Number of Patients: 34 
Recruitment Status: COMPLETED 
Condition: Colonoscopy 

NCTID: NCT04472598

Title: Study of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis 
Study Summary: Myelofibrosis is a type of bone marrow cancer that usually develops slowly and disrupts body’s normal production of blood cells. It causes bone marrow scarring, leading to severe anemia that can cause weakness and fatigue. It can also cause a low number of blood-clotting cells called platelets, which increases risk of bleeding. Myelofibrosis often causes an enlarged spleen. The purpose of this study is to see if a combination of navitoclax and ruxolitinib is more effective and safe in assessment of change in spleen volume when compared to ruxolitinib in participants with myelofibrosis.  Navitoclax is an investigational drug for the treatment of myelofibrosis. Participants in this study are divided into two groups, called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of myelofibrosis will be enrolled. Around 230 participants will be enrolled in approximately 190 sites worldwide.  Participants will receive oral navitoclax tablet with oral ruxolitinib tablet or oral ruxolitinib tablet with oral placebo (no active drug) tablet and treatment may continue untill the participant cannot tolerate the study drug, or benefit is not achieved, or other reasons which qualify for discontinuation of the study drug.  There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, magnetic resonance imaging (MRI) or computed tomography (CT) scan, bone marrow tests, checking for side effects, and completing questionnaires. 
Sponsor: AbbVie 
Intervention: Navitoclax 
Start Date: 2020-09-29 
Last Updated: 2023-04-27 
Number of Patients: 252 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Myelofibrosis (MF) 

NCTID: NCT02299596

Title: Physical Activity in Relation to Surgical Procedures 
Study Summary: This study will compare the outcome after surgery between a group of patients that receives instructions for prehabilitation training and one group that received standard treatment. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Physical activity 
Start Date: 2015-01 
Last Updated: 2023-11-24 
Number of Patients: 761 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Colorectal Cancer 

NCTID: NCT03656536

Title: A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma 
Study Summary: The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement. 
Sponsor: Incyte Corporation 
Intervention: Pemigatinib 
Start Date: 2019-06-03 
Last Updated: 2023-11-15 
Number of Patients: 434 
Recruitment Status: RECRUITING 
Condition: Unresectable Cholangiocarcinoma 

NCTID: NCT03658044

Title: Social Media on Prescription for Colorectal Cancer Patients 
Study Summary: The overall aim with this study is to get a deeper understanding of the potential benefits with a health platform for patients diagnosed with colorectal cancer. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Participation in the internet forum 
Start Date: 2018-12-01 
Last Updated: 2022-11-07 
Number of Patients: 44 
Recruitment Status: COMPLETED 
Condition: Colorectal Cancer 

NCTID: NCT05215535

Title: Liver Magnetic Resonance Imaging Before Treatment for Rectal Cancer. A Randomised Controlled Trial. 
Study Summary: This multicentre randomized controlled trial aims to investigate whether an abbreviated MRI is comparable to a combined single venous phase CT with an additional 3 min equilibrium phase of the liver, in the pretreatment radiological workup in patients with rectal cancer. 
Sponsor: Vastra Gotaland Region 
Intervention: Abbreviated MRI of the liver/abdomen 
Start Date: 2022-04-12 
Last Updated: 2022-04-27 
Number of Patients: 400 
Recruitment Status: RECRUITING 
Condition: Rectal Cancer 

NCTID: NCT04335669

Title: NordicTrip, a Translational Study of Preoperative Chemotherapy in TNBC 
Study Summary: Primary aim: To compare the effect on pathologic complete response (pCR) rate of adding capecitabine to carboplatin based preoperative chemotherapy in early ER-negative and HER2-negative breast cancer. Pembrolizumab is allowed in both arms after approval for TNBC 2022. 
Sponsor: Lund University Hospital 
Intervention: epirubicin, cyclophosphamide, paclitaxel, carboplatin, pembrolizumab 
Start Date: 2019-12-20 
Last Updated: 2023-03-27 
Number of Patients: 920 
Recruitment Status: RECRUITING 
Condition: Breast Cancer 

NCTID: NCT05083169

Title: A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma 
Study Summary: The purpose of this study is to compare the efficacy of teclistamab daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd). 
Sponsor: Janssen Research & Development, LLC 
Intervention: Daratumumab 
Start Date: 2021-10-14 
Last Updated: 2023-11-09 
Number of Patients: 587 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Multiple Myeloma 

NCTID: NCT04406974

Title: Locally Advanced Colorectal Cancer and Local Recurrences in Västra Götaland 
Study Summary: The aim of this study is to review the treatment strategies of locally advanced colorectal cancer and locally recurrent rectal cancer in Västra Götaland during 1995-2016. The aim is to evaluate time trends and outcome both related to morbidity and cancer specific survival, we will also evaluate the results after advanced reconstruction. The study will identify the population using the Swedish ColoRectal Cancer Registry and then the individual patient charts will be reviewed. The data will be collected in a clinical record form covering demography (age, sex, co-morbidity, BMI and diagnoses) as well as treatments strategy, surgical procedures, re-operations, complications, readmissions, hospital stay, stoma formation etc. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Surgery or treatment for local recurrence 
Start Date: 2018-01-01 
Last Updated: 2022-04-19 
Number of Patients: 4000 
Recruitment Status: RECRUITING 
Condition: Colorectal Neoplasms 

NCTID: NCT06117774

Title: Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC) 
Study Summary: The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS). 
Sponsor: Amgen 
Intervention: Tarlatamab 
Start Date: 2024-01-27 
Last Updated: 2023-11-07 
Number of Patients: 400 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Limited Stage Small Cell Lung Cancer 

NCTID: NCT04622176

Title: Magnetomotoric Ultrasound for Diagnostic Purposes in Rectal Cancer 
Study Summary: A magnetomotive ultrasound combines standard diagnostic ultrasound equipment with the application of an external time-varying magnetic field. The investigators aim to use this equipment to improve preoperative diagnostics in rectal cancer. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: MMUS 
Start Date: 2021-06-17 
Last Updated: 2022-04-14 
Number of Patients: 28 
Recruitment Status: RECRUITING 
Condition: Rectal Cancer 

NCTID: NCT04307576

Title: A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia 
Study Summary: ALLTogether collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new master protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised and interventional trials included in the study-design. 
Sponsor: Mats Heyman 
Intervention: Omitted Doxorubicin 
Start Date: 2020-07-13 
Last Updated: 2023-11-21 
Number of Patients: 6430 
Recruitment Status: RECRUITING 
Condition: Leukemia, Acute Lymphoblastic 

NCTID: NCT00975676

Title: Study of Estrogen Levels in Premenopausal Women Who Have Undergone Surgery for Breast Cancer and Are Receiving Triptorelin and Tamoxifen Citrate or Exemestane on Clinical Trial IBCSG 24-02 
Study Summary: RATIONALE: Studying samples of blood from patients with breast cancer in the laboratory may help doctors learn how well triptorelin given together with tamoxifen citrate or exemestane works in lowering estrogen levels.  PURPOSE: This clinical trial is studying estrogen levels in premenopausal women who have undergone surgery for breast cancer and are receiving triptorelin and tamoxifen citrate or exemestane on clinical trial IBCSG-2402. 
Sponsor: ETOP IBCSG Partners Foundation 
Intervention: gas chromatography / tandem mass spectometry 
Start Date: 2008-11-25 
Last Updated: 2021-10-25 
Number of Patients: 123 
Recruitment Status: COMPLETED 
Condition: Breast Cancer 

NCTID: NCT02181413

Title: A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant 
Study Summary: The purpose of this study is to determine the effect of ixazomib citrate maintenance therapy on progression-free survival (PFS), compared to placebo, in participants with newly diagnosed multiple myeloma (NDMM) who have had a response (complete response <math display="block">CR</math>, very good partial response <math display="block">VGPR</math>, or partial response <math display="block">PR</math>) to induction therapy followed by high-dose therapy (HDT) and autologous stem cell transplant (ASCT). 
Sponsor: Takeda 
Intervention: Ixazomib Citrate 
Start Date: 2014-07-01 
Last Updated: 2023-09-13 
Number of Patients: 656 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Multiple Myeloma 

NCTID: NCT04812470

Title: Hepatic Arterial Infusion of Autologous Tumor Infiltrating Lymphocytes in Patients With Melanoma and Liver Metastases 
Study Summary: The purpose of this study is to evaluate the feasibility, safety and tolerability of treatment with autologous tumor infiltrating lymphocytes (TIL) administered via hepatic arterial infusion in patients with liver metastases (including but not restricted to) of malignant melanoma. 
Sponsor: Vastra Gotaland Region 
Intervention: Autologous Tumor Infiltrating Lymphocytes 
Start Date: 2023-02-06 
Last Updated: 2023-02-10 
Number of Patients: 6 
Recruitment Status: RECRUITING 
Condition: Metastatic Uveal Melanoma 

NCTID: NCT04221035

Title: High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN) 
Study Summary: This is an international multicenter, open-label, randomized phase III trial including three sequential randomizations to assess efficacy of induction and consolidation chemotherapies and radiotherapy for patients with high-risk neuroblastoma. 
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris 
Intervention: Vincristine 
Start Date: 2019-11-05 
Last Updated: 2023-02-13 
Number of Patients: 800 
Recruitment Status: RECRUITING 
Condition: High-Risk Neuroblastoma 

NCTID: NCT03888313

Title: Pretreatment Group Consultation for Patients With Colorectal Cancer 
Study Summary: An explorative study of the patients’ experience of participating at a group consultation, together with other patients with newly diagnosed colon or rectal cancer 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Pretreatment group consultation 
Start Date: 2019-04-26 
Last Updated: 2021-09-29 
Number of Patients: 161 
Recruitment Status: COMPLETED 
Condition: Colorectal Neoplasm 

NCTID: NCT02993276

Title: Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma 
Study Summary: PROSPECTIVE COHORT EVALUATION OF NEUROCAP® In the Treatment of symptomatic Neuroma (PROTECT Neuro)  This post-market surveillance study is conducted to provide post market surveillance information regarding long-term performance and ease of use of the Polyganics nerve capping device (NEUROCAP®) for reduction of the development of peripheral symptomatic end-neuroma. 
Sponsor: Polyganics BV 
Intervention: Neurocap® 
Start Date: 2017-04-17 
Last Updated: 2020-09-10 
Number of Patients: 73 
Recruitment Status: COMPLETED 
Condition: Neuroma 

NCTID: NCT00071799

Title: A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional Care 
Study Summary: The purpose of this study is to determine whether patients with high-risk myelodysplastic syndromes (MDS) treated with azacitidine have improved survival compared to conventional care treatments. The study will also assess the effect of treatments on response, duration of response, and transformation to acute myeloid leukemia (AML). The study will continue for 12 months following last patient enrolled.  See study AZA PH GL 2003 CL 001 E for information about the extension to this study. 
Sponsor: Celgene 
Intervention: Azacitidine 
Start Date: 2003-11-01 
Last Updated: 2019-10-29 
Number of Patients: 358 
Recruitment Status: COMPLETED 
Condition: Myelodysplastic Syndromes 

NCTID: NCT03040401

Title: A Study of HDC/IL-2 Treatment in Chronic Myelomonocytic Leukemia (CMML) 
Study Summary: Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and/or IL-2 (Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3- or 6 week rest periods.  All subjects will be assigned to one of three consecutive cohorts, each comprising five patients.  Cohort 1 will receive HDC without IL-2 for the first treatment cycle, to enable the assessment of short-term impact of HDC alone on clonal and immunological markers. For all remaining cycles the combination of HDC and IL-2 will be given.  Cohort 2 will receive the combination of Ceplene and Proleukin in all cycles. After all patients in cohorts 1 and 2 have completed 4 treatment cycles, immunological and clinical response and toxicity will be evaluated. On the basis of the results for the first 4 cycles of cohorts 1 and 2, a third cohort of 5 patients will be enrolled receiving either the combination of HDC/IL-2 or HDC alone.  In case of a beneficial response* after 4 cycles, treatment may be continued to a total of 10 cycles. Treatment cycles 5-10 will comprise 3 weeks of treatment and 6-week rest periods.  IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2. The patient or a family member/significant other will be instructed to administer injections of both study drugs to allow safe treatment at home. 
Sponsor: Vastra Gotaland Region 
Intervention: Cohort 1, Ceplene® and Proleukin® 
Start Date: 2017-02-15 
Last Updated: 2017-12-19 
Number of Patients: 15 
Recruitment Status: UNKNOWN 
Condition: Leukemia, Myelomonocytic, Chronic 

NCTID: NCT03709680

Title: Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors 
Study Summary: A study to learn about safety and find out maximum tolerable dose of palbociclib given in combination with chemotherapy (temozolomide with irinotecan or topotecan with cyclophosphamide) in children, adolescents and young adults with recurrent or refractory solid tumors (phase 1). Neuroblastoma tumor specific cohort to further evaluate antitumor activity of palbociclib in combination with topotecan and cyclophosphamide in children, adolescents, and young adults with recurrent or refractory neuroblastoma. Phase 2 to learn about the efficacy of palbociclib in combination with irinotecan and temozolomide when compared with irinotecan and temozolomide alone in the treatment of children, adolescents, and young adults with recurrent or refractory Ewing sarcoma (EWS). 
Sponsor: Pfizer 
Intervention: Palbociclib 
Start Date: 2019-05-24 
Last Updated: 2023-11-22 
Number of Patients: 184 
Recruitment Status: RECRUITING 
Condition: Ewing Sarcoma 

NCTID: NCT04272034

Title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors 
Study Summary: The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors. 
Sponsor: Incyte Corporation 
Intervention: INCB099318 
Start Date: 2021-03-26 
Last Updated: 2023-08-16 
Number of Patients: 105 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Advanced Solid Tumors 

NCTID: NCT05939401

Title: A Study Regarding Tissue Response During and After Treatment for Anal Cancer 
Study Summary: The aim of this study is to improve the understanding for the tumour biology in relation to treatment response in patients with anal cancer by examining:  * The tumour microenvironment * The localisation of and cellular interactions between the tumour and immune cells * The gene and protein expression by cells present in the tumour and surrounding tissue. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Biopsies 
Start Date: 2023-11-01 
Last Updated: 2023-11-07 
Number of Patients: 400 
Recruitment Status: NOT_YET_RECRUITING 
Condition: Anal Cancer 

NCTID: NCT02759380

Title: Can Dietary Phytoestrogens Slow Down Prostate Tumor Proliferation? 
Study Summary: The purpose of this study is to evaluate if a diet with a high content of phytoestrogens can slow down the prostate tumor proliferation. Phytoestrogens are found in food items such as soy, rye, and seeds.  Two hundred thirty men with prostate cancer will be included in the study and followed until surgery (at least 6 weeks). Half of the study participants will receive general information about healthy food choices and a package of foods with high content of phytoestrogens to add to their food. The other half will get the same information but not receive the food-package. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: Phytoestrogen-rich foods 
Start Date: 2016-03 
Last Updated: 2023-01-20 
Number of Patients: 240 
Recruitment Status: RECRUITING 
Condition: Prostate Cancer 

NCTID: NCT04461457

Title: Targeted Radiation Therapy for Ovarian Cancer: Intraperitoneal Treatment With 211-astatine-MX35 F(ab’)2 
Study Summary: In this alpha-radioimmunotherapy study groups of 3 patients with recurring epithelial ovarian cancer treated by salvage chemo-therapy and being in complete or good partial remission will receive one intra peritoneal infusion of 211 astatine (211At)-MX35 F(ab’)2 . Patients will receive a single dose of MX35 F(ab’)2 radiolabeled with increasing activity concentration of 211At in 1.0 - 2 L Extraneal® solution starting at an activity concentration of 50 megabecquerel per litre (MBq/L). 
Sponsor: Vastra Gotaland Region 
Intervention: 211-astatine MX35 F(ab’)2 
Start Date: 2005-02-05 
Last Updated: 2020-07-08 
Number of Patients: 12 
Recruitment Status: COMPLETED 
Condition: Ovarian Cancer 

NCTID: NCT03032224

Title: Analysis of Body Composition in Relation to Outcome After Surgery in a Cohort of Patients With Esophageal Cancer 
Study Summary: The occurrence of dysphagia is a well-known early feature of esophageal cancer that may reduce caloric intake and thus cause weight loss. Sarcopenia is considered to be a consequence of such involuntary nutritional restriction. The prevalence of sarcopenia in patients with esophageal cancer before and after surgery is not well known and its possible consequences have been debated.  Aim: The aim of this study was to prospectively explore body composition and function in a cohort of patients with esophageal cancer before and after surgery with curative intent. In particular, to investigate the prevalence and development of sarcopenia and body composition as a consequence to surgery for esophageal cancer and the possible relation to morbidity, length of stay and quality of life (QoL).  Methods: In a cohort of 76 patients who had esophageal- or cardia-cancer and were planned for surgery with a curative intent, data on body-composition measured with bioimpedance, working capacity (cardiac stress test), grip strength and QoL (European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)-C30 version 3.0) were prospectively collected. Data regarding dysphagia was derived from an esophagus related quality of life form (EORTC QLQ-OES18). Data on tumour stage and type, complications, length of stay and preoperative weight loss were collected from medical charts. 
Sponsor: Vastra Gotaland Region 
Intervention: Resection of the esophagus and the gastroesophageal junction 
Start Date: 2015-03-23 
Last Updated: 2020-07-28 
Number of Patients: 76 
Recruitment Status: COMPLETED 
Condition: Cancer of Esophagus 

NCTID: NCT04303780

Title: Study to Compare AMG 510 “Proposed INN Sotorasib” With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200). 
Study Summary: A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation 
Sponsor: Amgen 
Intervention: AMG 510 
Start Date: 2020-06-04 
Last Updated: 2023-10-23 
Number of Patients: 345 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: KRAS p, G12c Mutated /Advanced Metastatic NSCLC 

NCTID: NCT01048034

Title: Evaluation of Azacitidine in Transfusion Dependent Patients With Low-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) 
Study Summary: Azacitidine has proved prolonged overall survival in patients with high-risk MDS. Minor pilot studies have shown that treatment with Azacitidine can induce transfusion independency in previous transfusion dependent patients with low-risk MDS. This study will evaluate the effect of Azacitidine in transfusion dependent patients with low-risk MDS (IPSS low or int-1) or low risk CMML. Included patients should first have failed, or considered not being eligible to, treatment with EPO +/- G-CSF. Our hypothesis is that Azacitidine can lead to transfusion independency in this group of patients. Those patients who do not respond to treatment with Azacitidine alone, will be given treatment with the combination of Azacitidine and EPO where our hypothesis is that Azacitidine can restore sensitivity to EPO. 
Sponsor: Nordic MDS Group 
Intervention: Azacitidine 
Start Date: 2010-01 
Last Updated: 2013-10-29 
Number of Patients: 30 
Recruitment Status: COMPLETED 
Condition: Myelodysplastic Syndrome 

NCTID: NCT05052801

Title: Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression 
Study Summary: The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC) 
Sponsor: Amgen 
Intervention: Bemarituzumab 
Start Date: 2022-03-07 
Last Updated: 2023-11-27 
Number of Patients: 516 
Recruitment Status: RECRUITING 
Condition: Gastric Cancer 

NCTID: NCT04927780

Title: Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer 
Study Summary: The PREOPANC-3 study is a randomized, multicenter, phase 3 trial. Patients with resectable pancreatic cancer will be randomly assigned (1:1) to 8 cycles of neoadjuvant mFOLFIRINOX followed by surgery and 4 cycles of adjuvant mFOLFIRINOX (arm 1) or to upfront surgery followed by 12 cycles of adjuvant mFOLFIRINOX (arm 2).  The primary objective of the trial is to determine whether perioperative mFOLFIRINOX improves overall survival compared with adjuvant mFOLFIRINOX in patients with resectable pancreatic cancer. 
Sponsor: Erasmus Medical Center 
Intervention: Leucovorin Calcium 
Start Date: 2021-09-07 
Last Updated: 2023-08-15 
Number of Patients: 378 
Recruitment Status: RECRUITING 
Condition: Pancreatic Cancer 

NCTID: NCT00963534

Title: Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma. 
Study Summary: In phase I: Establishing maximally tolerated dose of lenalidomide in combination with bendamustine and rituximab.  In phase II: Evaluation of progression free survival with treatment with lenalidomide, bendamustine and rituximab 
Sponsor: Lund University Hospital 
Intervention: lenalidomide, bendamustine, rituximab 
Start Date: 2009-09 
Last Updated: 2018-03-12 
Number of Patients: 51 
Recruitment Status: COMPLETED 
Condition: Mantle Cell Lymphoma 

NCTID: NCT04729634

Title: Survey Of Mobilisation and Breathing Exercises After Thoracic and Abdominal Surgery 
Study Summary: Background  Thoracic or abdominal surgeries are followed by a shorter or longer period of immobilization and after major surgery there is a higher risk of developing cardiorespiratory complications. To prevent these complications, the patient is encouraged to change position and exercise in bed, get out of bed as early and as much as possible after the operation and to breathe with or without aids. There is no general definition of early mobilization and may start within a few hours to a few days after surgery. There is currently a lack of knowledge nationally and internationally about when the mobilization starts and what it contains.  Many patients also receive breathing training in connection with the surgery. There is currently no consensus on which method is preferable for which groups of patients. There are similarities and differences in practice in the world regarding postoperative breathing training. There are studies that have mapped practice after primarily thoracic surgery but also abdominal surgery. However, there are no studies that have mapped when the prescribed breathing training starts after different types of operations.  The purpose of the study is to map when mobilization and breathing training starts after abdominal and thoracic surgery and what is then performed  Method The study will be carried out as a quality follow-up with mapping of practice. Patients ≥ 18 years of age who are undergoing a planned or acute open, keyhole or robot-assisted surgery, who are extubated and who breathe spontaneously will be included. Exclusion criteria are completed plastic, trauma, orthopedic or transplant surgery.  The material will be recruited from Swedish university hospitals and county hospitals for 20 days of surgery (Monday through Thursday) for five consecutive weeks.  Clinical benefit The study will mean that clinical practice is presented which, with regard to mobilization, is the first study ever that will present when this takes place and what is done and, with regard to breathing training, the first that shows when this training is initiated. 
Sponsor: Göteborg University 
Intervention: Mobilization 
Start Date: 2021-09-01 
Last Updated: 2022-08-16 
Number of Patients: 1492 
Recruitment Status: COMPLETED 
Condition: Abdominal Cancer 

NCTID: NCT05625698

Title: Premarking of Axillary Nodes Before Start of Neoadjuvant Chemotherapy Using Magnetic Approach 
Study Summary: Breast cancer is one of the commonest types of cancers in females. Treatments include surgery followed by anti-estrogen therapy, radiotherapy and chemotherapy. During breast surgery, the surgeon removes the cancer from the breast and lymph nodes (glands) from the armpit.  Historically, all armpit lymph nodes were surgically removed but this approach is associated long term problems of arm swelling. In more recent times, an increasingly more selective approach is used to treat the armpit nodes. In the presence of cancer spreads in the nodes, an axillary clearance surgery is done otherwise, only the first node(s) also called sentinel node(s) that drain fluids from the cancer, is surgically removed. The identification of nodes using the latter approach is helped by injecting a tracer in the breast and via the lymphatic channels, the tracer is then concentrated in the sentinel nodes.  Over recent years, neoadjuvant (preoperative) chemotherapy is being increasingly used to treat breast cancers. This treatment approach can lead up to a large of number of complete cancer response. This in turn can cause difficulties in locating the breast cancer / armpit nodes during surgery after the chemotherapy.  New developments like superparamagnetic iron oxide nanoparticles (SPIO or MagTrace®) has been used as an alternate liquid tracer to mark sentinel nodes to facilitate armpit surgery. In addition, small magnetic clip called Magseed® has also been developed which can be inserted into the relevant lymph nodes thereby marking their anatomical position to facilitate surgery. Both MagTrace and Magseed can be used to pre-mark the cancer and armpit nodes before the start of neoadjuvant chemotherapy. In theory, premarking armpit nodes using a magnetic approach is associated with better surgical accuracy in the armpit but there is limited supporting data.  Therefore, this study aims to investigate the feasibility of premarking armpit nodes, with or without cancer spread, using magtrace and magseed respectively before patients undergo neoadjuvant chemotherapy. 
Sponsor: Sahlgrenska University Hospital, Sweden 
Intervention: MagTrace only 
Start Date: 2021-10-01 
Last Updated: 2022-11-23 
Number of Patients: 80 
Recruitment Status: RECRUITING 
Condition: Breast Cancer 

NCTID: NCT00625898

Title: BETH Study: Treatment of HER2 Positive Breast Cancer With Chemotherapy Plus Trastuzumab vs Chemotherapy Plus Trastuzumab Plus Bevacizumab 
Study Summary: The trial will determine the value of adding bevacizumab to chemotherapy plus trastuzumab in patients with resected node-positive or high risk node-negative, HER2-positive breast cancer. 
Sponsor: NSABP Foundation Inc 
Intervention: Docetaxel 
Start Date: 2008-04 
Last Updated: 2020-09-10 
Number of Patients: 3509 
Recruitment Status: TERMINATED 
Condition: Breast Cancer 

NCTID: NCT03776136

Title: Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) for Advanced Melanoma in Anti-Programmed Death-1/Programmed Death-Ligand 1 (PD-1/L1)-Exposed Participants (MK-7902-004/E7080-G000-225/LEAP-004) 
Study Summary: This study will evaluate the safety and efficacy of combination therapy of lenvatinib (E7080/MK-7902) and pembrolizumab following approximately 2 years of pembrolizumab therapy and approximately 2 years or more lenvatinib therapy in adult participants with unresectable or advanced melanoma who have been exposed to anti-PD-1/L1 agents approved for unresectable or metastatic melanoma. No statistical hypothesis will be tested in this study. 
Sponsor: Merck Sharp & Dohme LLC 
Intervention: lenvatinib 
Start Date: 2019-01-30 
Last Updated: 2023-10-17 
Number of Patients: 103 
Recruitment Status: COMPLETED 
Condition: Advanced Melanoma 

NCTID: NCT04557098

Title: A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma 
Study Summary: The purpose of this study is to evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D). 
Sponsor: Janssen Research & Development, LLC 
Intervention: Teclistamab 
Start Date: 2020-09-17 
Last Updated: 2023-11-09 
Number of Patients: 194 
Recruitment Status: ACTIVE_NOT_RECRUITING 
Condition: Hematological Malignancies 

NCTID: NCT00602511

Title: Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma 
Study Summary: The purpose of the study is to compare thalidomide + dexamethasone with bortezomib + dexamethasone in patients with multiple myeloma refractory to melphalan therapy. The main goal is to find out which of these two 2:nd line regimens that offers the patients the best chance for a response with as long duration and as good quality of life as possible. 
Sponsor: Nordic Myeloma Study Group 
Intervention: Bortezomib 
Start Date: 2007-10 
Last Updated: 2011-02-09 
Number of Patients: 300 
Recruitment Status: COMPLETED 
Condition: Multiple Myeloma 

NCTID: NCT01694511

Title: Endoscopic Detection of Dysplasia in Barrett’s Esophagus 
Study Summary: The purpose of this study is to determine whether High Resolution Magnification Endoscopy (HRME) and Computed Virtual Chromoendoscopy (CVC) with targeted biopsies is superior to conventional white light endoscopy (WLE) with 4 quadrant biopsies of the metaplastic epithelium every 1-2 cm (Seattle Protocol) for detection of pre-malignant lesions in patients with Barrett’s Esophagus (BE). 
Sponsor: Göteborg University 
Intervention: HRME+CVC 
Start Date: 2009-11 
Last Updated: 2014-02-10 
Number of Patients: 111 
Recruitment Status: COMPLETED 
Condition: Barrett’s Esophagus 

NCTID: NCT02631070

Title: A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes 
Study Summary: The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.  This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) versus placebo in participants with anemia due to the Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate MDS with ring sideroblasts who require red blood cell (RBC) transfusions. 
Sponsor: Celgene 
Intervention: Luspatercept 
Start Date: 2016-02-09 
Last Updated: 2021-12-17 
Number of Patients: 229 
Recruitment Status: COMPLETED 
Condition: Myelodysplastic Syndromes 

NCTID: NCT00798070

Title: Panther: A Study Comparing Biweekly and Tailored EC-T Versus Three Weekly FEC-T in Breast Cancer Patients 
Study Summary: This is an adjuvant, open, prospective, randomized study to compare:  A. Individually tailored and two weekly dosed epirubicin + cyclophosphamide followed by a three weeks break followed by biweekly and tailored docetaxel (dtEC→dtT) given every second week, to  B. Fixed dosed and three weekly epirubicin, cyclophosphamide and 5-fluorouracil, followed by fixed dosed and three weekly docetaxel (FEC→T).  Patients with primary node-positive or high risk lymph node negative breast cancer will be eligible for the study.  The primary objective of the phase 3 study is to compare breast cancer relapse-free survival (BCRFS) between the dtEC→dtT and FE100C→T. To detect a five-year BCRFS difference of 0.710 to 0.790 about 1000 patients per arm will be needed. They will be recruited during four years and followed another two years for breast cancer events.  Secondary objectives are to compare  # Distant disease-free survival (DDFS) # Event-free survival and # Overall survival # Health-related quality of life and toxicity analyses according to CTC # Outcome in relation to tumour biological factors and polymorphism patterns ## RFS in relation to the Sorlie classes using immunohistochemical markers and/or gene expression profiling comparing A vs B arm ## RFS with receptor positive disease (analyzed in the local laboratories as described in the CRFs and also analyzed as continuous variables) in the comparison between the A- and B- arms. ## RFS with high and low proliferation, respectively, (analyzed in the local laboratories as described in the CRFs and also analyzed as a continuous variable, or centrally analyzed), in the comparison between the A- and B-arms. ## RFS in relation to HER-2 

eu status (analyzed in the local laboratories as described in the CRFs) in the primary cancers in the comparison between the A- and B-arms and analyzed whether trastuzumab was given in sequence or concurrently. ## RFS analyzed in relation to other molecular markers (e.g. gene expression profiling/ sequencing) in the primary cancers and SNPs signatures in normal DNA (related to toxicities for EC/FEC and docetaxel components, respectively, and given dose levels and outcome in relation to these factors and in relation QoL) to outcome per arm. ## RFS analyzed in relation to tumour associated lymphocytes and Y-box binding protein in the comparison between the A- and B-arms. Tumour tissue will be obtained and stored for studies of prognostication and therapy prediction. Last patient randomized was September 2011.

Sponsor: Karolinska University Hospital 
Intervention: dtEC→dtT 
Start Date: 2007-02 
Last Updated: 2020-09-03 
Number of Patients: 2017 
Recruitment Status: UNKNOWN 
Condition: Breast Cancer

hasCancerType::C00-D48: All neoplasms hasCancerType::C00-C97: All cancer types hasCancerType::C00-C14: Mouth/throat cancers hasCancerType::C15-C26: Digestive system cancers hasCancerType::C30-C39: Lung/chest cancers hasCancerType::C40-C41: Bone cancers hasCancerType::C43-C44: Skin cancers/melanoma hasCancerType::C45-C49: Soft tissue cancer hasCancerType::C50: Breast cancer hasCancerType::C51-C58: Female genitalia cancers hasCancerType::C60-C63: Male genitalia cancer hasCancerType::C64-C68: Urinary system cancers hasCancerType::C69-C72: Eye and brain cancer hasCancerType::C73-C75: Thyroid and other gland cancers hasCancerType::C76-C80: Cancers of unknown or unspecified areas hasCancerType::C81-C96: Cancers of the blood and immune system hasCancerType::C97-C97: Cancers in multiple locations from the start hasCancerType::D00-D09: Early-stage cancers not yet spread hasCancerType::D10-D36: Benign tumour hasCancerType::D37-D48: Growths of uncertain nature hasCancerType::unknown isTrial