Trials (Uppsala University Hospital)
From Beacon
Go back to Uppsala University Hospital page
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: NCT01227356
Title: A Study Comparing Imatinib and Imatinib/Pegylated Interferon in Chronic Myeloid Leukemia Study Summary: Patients with chronic myeloid leukemia in imatinib induced CHR are randomized between imatinib 400 mg daily and imatinib 400 mg daily + PegIntron 30 ug weekly. Primary endpoint: To compare at 12 months between the treatment arms the rate of Major Molecular Response (=99,9% tumour reduction) at 12 months Sponsor: Uppsala University Intervention: imatinib and pegylated interferon Start Date: 2004-09 Last Updated: 2010-10-25 Number of Patients: 112 Recruitment Status: COMPLETED Condition: Health Care Quality
NCTID: NCT01347697
Title: Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer Study Summary: The trial compares two different techniques for reconstruction of the lesser pelvic floor after an extended abdominoperineal excision for locally advanced rectal cancer. The alternative reconstruction techniques in the trial are: * a technique using a gluteus maximus myocutaneous flap or * a technique using an acellular porcine collagen implant (biological mesh) The primary endpoint will be physical performance six months from operation and our hypothesis is that the technique using an acellular porcine implant will cause less impaired physical performance compared to the technique using a myocutaneous flap. The study is interventional, randomized and by definition a comparative effectiveness research project. Sponsor: Umeå University Intervention: Reconstruction with an acellular porcine dermal collagen implant (biological mesh) Start Date: 2011-09-05 Last Updated: 2023-05-03 Number of Patients: 91 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Rectal Cancer
NCTID: NCT06002659
Title: CAR20(NAP)-T Therapy for B Cell Lymphoma (CARMA-01 Study) Study Summary: The purpose is to study the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CAR20(NAP)-T for patients with B-cell malignancies. Sponsor: Uppsala University Intervention: CAR20(NAP)-T Start Date: 2023-12-01 Last Updated: 2023-08-21 Number of Patients: 18 Recruitment Status: NOT_YET_RECRUITING Condition: B-cell Lymphoma
NCTID: NCT00334854
Title: Ifosfamide and Doxorubicin, Radiation Therapy, and/or Surgery in Treating Young Patients With Localized Soft Tissue Sarcoma Study Summary: RATIONALE: Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy with or without radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase III trial is studying how well giving ifosfamide and doxorubicin, radiation therapy, and/or surgery works in treating young patients with localized soft tissue sarcoma. Sponsor: European Paediatric Soft Tissue Sarcoma Study Group Intervention: doxorubicin hydrochloride Start Date: 2006-03 Last Updated: 2013-08-12 Number of Patients: 250 Recruitment Status: UNKNOWN Condition: Childhood Malignant Fibrous Histiocytoma of Bone
NCTID: NCT00212615
Title: XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer Study Summary: XELOX (Capecitabine and Oxaliplatin) is an effective and convenient regimen for patients with metastatic colorectal cancer. Chronomodulated therapy may reduce toxicity. Patients will be randomized to standard XELOX (Capecitabine 1000 mg/m² in the morning and 1000 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes) or chronomodulated XELOX (Capecitabine 400 mg/m² in the morning and 1600 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes). Bloodsamples will be collected and frozen and later examined for potential predictive factors Sponsor: Odense University Hospital Intervention: Oxaliplatin (Eloxatin) Start Date: 2004-02 Last Updated: 2020-11-06 Number of Patients: 116 Recruitment Status: COMPLETED Condition: C04.588.274.476.411.307
NCTID: NCT02730416
Title: Combination Chemotherapy With Nintedanib / Placebo in Endometrial Cancer Study Summary: This study will evaluate the role of addition of an anti-angiogenic agent (Nintedanib/placebo) to conventional combination chemotherapy as concomitant and maintenance treatment in primary advanced or with first relapse of endometrial cancer. Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit Intervention: Nintedanib or Placebo; Carboplatin, Paclitaxel Start Date: 2016-12-12 Last Updated: 2023-09-21 Number of Patients: 146 Recruitment Status: COMPLETED Condition: Endometrial Cancer
NCTID: NCT01455259
Title: Phase I/IIa AdCD40L Immunogene Therapy for Malignant Melanoma and Other Solid Tumors Study Summary: In this phase I/II trial, immunostimulatory gene therapy (AdCD40L) will be investigated. In Part 1 patients with melanoma will receive AdCD40L as mono therapy. In Part 2A, patients with melanoma and patients with other solid tumors will receive AdCD40L in combination with low dose cyclophosphamide. In Part 2B, patients with melanoma will receive AdCD40L in combination with one local radiotherapy and cyclophosphamide. Sponsor: Uppsala University Intervention: AdCD40L Start Date: 2011-09 Last Updated: 2016-02-17 Number of Patients: 30 Recruitment Status: COMPLETED Condition: Malignant Melanoma
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: NCT03658967
Title: Clinical Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema (AdeLE) Study Summary: This study evaluates the efficacy of Lymfactin® in patients with secondary lymphedema associated with the treatment of breast cancer by comparing the effects of active study treatment Lymfactin® to placebo. The study product will be administered in combination with a surgical lymph node transfer operation. In addition, the safety and tolerability of the Lymfactin® treatment will be evaluated. Sponsor: Herantis Pharma Plc. Intervention: Lymfactin® (1x10E11 vp) Start Date: 2018-06-07 Last Updated: 2023-10-19 Number of Patients: 39 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Secondary Lymphedema
NCTID: NCT04083547
Title: Circulating Tumour Cells in Patients With Peritoneal Metastases Study Summary: This study aims to evaluate the prognostic value of circulating tumour cells (CTC) in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy due to gastrointestinal cancers that have spread to the peritoneum. Sponsor: Uppsala University Intervention: iCellate Start Date: 2017-10-17 Last Updated: 2020-11-04 Number of Patients: 114 Recruitment Status: COMPLETED Condition: Circulating Tumor Cell
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: NCT03697707
Title: Efficacy and Safety of Immunotherapy With Allogeneic Dendritic Cells, DCP-001, in Patients With Acute Myeloid Leukaemia Study Summary: Phase II study to evaluate safety and efficacy of DCP-001 in patients with AML in CR, and with presence of MRD Sponsor: Mendus Intervention: DCP-001 Start Date: 2018-10-15 Last Updated: 2022-10-10 Number of Patients: 20 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Acute Myeloid Leukemia in Remission
NCTID: NCT02907385
Title: Efficacy and Safety of LifeSeal™ Kit for Colorectal Staple Line Sealing Study Summary: LifeSeal™ Kit, surgical sealant designed for staple-line reinforcement that is applied over the anastomotic line to prevent bowel content leakage until full physiological function is restored. RATIONALE : Postoperative anastomotic leakage is one of the most devastating and feared complications in colorectal surgery. The risk of postoperative anastomotic leakage varies widely depending on the level of anastomosis while the risk is higher in low anastomosis. In order to best demonstrate the benefits of LifeSeal™ in providing staple line reinforcement and helping to reduce leaks, the study includes high risk anastomoses, defined as colorectal and coloanal anastomoses performed within 10 cm from the anal verge. STUDY DESIGN: This study is designed as a prospective, multi-center, multinational randomized, single-blind, double armed study PRIMARY OBJECTIVE: The primary objective of this study is to assess the efficacy and safety of LifeSeal™ Kit as measured by the change in overall anastomotic leak rates in subjects undergoing low anterior resection with an anastomosis below 10 cm from the anal verge, over the first 17 weeks after surgery. SECONDARY OBJECTIVES: The secondary objective of this study is to assess the incidence of post-operative leaks and additional benefits that could be related to the use of LifeSeal™ Kit such as reducing the severity and improving the outcome of a leak once it has occurred. In addition, the study will allow for collection and analysis of additional safety data and usability assessment of the device, medical resource utilization, and health related quality of life measures. Sponsor: LifeBond Ltd. Intervention: LifeSeal™ Kit Start Date: 2016-11 Last Updated: 2018-03-30 Number of Patients: 736 Recruitment Status: UNKNOWN Condition: Rectal Cancer
NCTID: NCT05361083
Title: First-in-human Evaluation of [18F]CETO Study Summary: Purpose of this clinical phase 1 trial was to determine if para-chloro-2-<math display="block">18F</math>fluoroethyletomidate positron emission computed tomography (<math display="block">18F</math>CETO-positron emission computed tomography(PET)/computed tomography(CT)) can be used in diagnostics of adrenal tumors and if the biochemical/pharmacological states conditions in humans with various illnesses, compared to healthy humans, such as the radio tracer is suitable? Sponsor: Uppsala University Intervention: F18CETO Start Date: 2019-09-01 Last Updated: 2022-05-04 Number of Patients: 20 Recruitment Status: COMPLETED Condition: Primary Aldosteronism Due to Aldosterone Producing Adenoma
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: NCT03625037
Title: First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma Study Summary: The trial is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). The trial consists of 3 parts: * a dose-escalation part (Phase 1, first-in-human (FIH)) * an expansion part (Phase 2a) * a dose-optimization part (Phase 2a) Sponsor: Genmab Intervention: Epcoritamab Start Date: 2018-06-26 Last Updated: 2023-08-08 Number of Patients: 786 Recruitment Status: RECRUITING Condition: Diffuse Large B-cell Lymphoma (DLBCL)
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: 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: NCT03225989
Title: Trial Investigating an Immunostimulatory Oncolytic Adenovirus for Cancer Study Summary: This Phase I/II trial evaluates LOAd703 in patients with cancer (pancreatic, biliary, colorectal or ovarian) together with their standard of care chemotherapy or using gemcitabine immune-conditioning. LOAd703 is administered by intratumoral image-guided injections. Maximum 50 patients can be enrolled. LOAd703 is an immunostimulatory gene therapy using an selection replication competent adenovirus as a gene vehicle. The virus is derived from serotype 5 adenovirus with the fiber from serotype 35. It expresses the transgenes trimerized membrane-bound isoleucine zipper (TMZ) TMZ-CD40L and 41BBL under control of a cytomegalovirus (CMV) promoter. Sponsor: Lokon Pharma AB Intervention: LOAd703 Start Date: 2018-03-01 Last Updated: 2023-04-13 Number of Patients: 46 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Pancreatic Adenocarcinoma
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: 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: NCT00660582
Title: FLOX + Cetuximab (Erbitux®) for Patients With Metastatic Colorectal Cancer and Wild Type K-RAS Tumor Study Summary: The Nordic FLOX-regime consists of a combination of bolus 5-FU, leukovorin and oxaliplatin (Eloxatin®). Cetuximab (Erbitux®) is an antibody against the epidermal growth factor receptor (EGFR). The combination of FLOX and weekly Erbitux has been investigated in the Nordic VII study where 571 patients were randomized to FLOX (regime A) or FLOX + Erbitux (regime B or C). Effect-data has not yet been published but the combination is well tolerated, and other studies have shown that Erbitux administered with chemotherapy seem to be more efficient than chemotherapy alone. The main purpose with this study is to investigate the effect of FLOX and Erbitux given every second week as first line treatment for patients with metastatic colorectal cancer and K-RAS wildtype tumor. The latest accessible data regarding treatment towards EGFR and K-RAS mutations shows that patients with K-RAS wildtype responds better to treatment than patients with K-RAS mutations. Sponsor: Per Pfeiffer Intervention: Cetuximab (Erbitux) Start Date: 2008-04 Last Updated: 2015-01-21 Number of Patients: 152 Recruitment Status: COMPLETED Condition: Metastatic Colorectal Cancer
NCTID: NCT03456063
Title: A Study of Neoadjuvant Atezolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer (IMpower030) Study Summary: This is a randomized, double-blinded study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in participants with resectable Stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC) followed by open-label adjuvant/postoperative atezolizumab or best supportive care and monitoring. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Start Date: 2018-04-24 Last Updated: 2023-10-27 Number of Patients: 453 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-Small-Cell Lung
NCTID: NCT01858116
Title: PET Study of Breast Cancer Patients Using [68Ga]ABY-025 Study Summary: The study will evaluate <math display="block">68Ga</math>ABY-025 for PET imaging of HER2 expression in subjects with HER2-positive or HER2-negative breast cancer. Sponsor: Biomedical Radiation Sciences Intervention: [68Ga]ABY-025 Start Date: 2013-04 Last Updated: 2015-01-13 Number of Patients: 16 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT03068416
Title: CD19-targeting, 3rd Generation CAR T Cells for Refractory B Cells Malignancy Study Summary: Treatment of patients with B cell lymphoma or leukemia with two doses of CD19-targeting chimeric antigen receptor (CAR) T cells to evaluate for safety and efficacy. Sponsor: Uppsala University Intervention: CAR T cells Start Date: 2017-09-18 Last Updated: 2021-10-20 Number of Patients: 24 Recruitment Status: COMPLETED Condition: B-cell Leukemia
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: 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: NCT04680052
Title: A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma. Study Summary: This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL. Sponsor: Incyte Corporation Intervention: tafasitamab Start Date: 2021-04-15 Last Updated: 2023-08-18 Number of Patients: 654 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Follicular Lymphoma
NCTID: NCT01725204
Title: Safety and Efficacy of Pegylated IFN-alpha 2B Added to Dasatinib in Newly Diagnosed Chronic Phase Myeloid Leukemia Study Summary: Patients with newly diagnosed CML have excellent outcomes with tyrosine kinase inhibitors (TKI). However, a few patients will be cured with TKIs alone, and thus need continued life-long treatment. Some patients achieve complete molecular remission (CMR), and this rate is higher with second generation TKIs compared with imatinib. Some experience with drug discontinuation in CMR has been derived from a few small studies, most notably the French STIM study. Approximately 40 % of patients with a minimum of two years in MR4.5 (4.5 log reduction in molecular response) can stop imatinib without relapse, indicating possible cure. To increase the non-relapse rate is of major importance. To achieve a permanent “cure” without stem cell transplantation is presently the most relevant goal of clinical studies in CML. The investigators hypothesize that to significantly increase cure rates in CML, therapy should eradicate leukemic stem cells and/or induce or restore anti-CML immunity. Second generation TKIs may have a more profound effect on the stem cell pool as compared to imatinib. This is assessed in our current randomized study with a reduction in leukemic stem cell burden as the primary endpoint (NordCML006). Interferon-alpha (IFN) has a prominent immunomodulatory and antiproliferative mode of action, and has also activity in stem cells. Pegylated IFN in combination with imatinib results in improved therapy responses as compared to imatinib monotherapy. This advantage may translate into higher cure rates. Dasatinib has a unique dual mechanism of action: it is the most potent of available TKIs and induces immunological effects that are different from those of IFN. Both of these drugs may have immunological adverse-effects when used as a monotherapy. However, immunological adverse-effects may also be markers of anti-leukemia efficacy. A combination of dasatinib and pegylated IFN (PegIFN) may have additive or synergistic effects and should be tested in a clinical study. Sponsor: Norwegian University of Science and Technology Intervention: Dasatinib + PegIFN Start Date: 2012-09 Last Updated: 2017-09-25 Number of Patients: 40 Recruitment Status: COMPLETED Condition: Leukemia, Myeloid, Chronic-Phase
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: 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: NCT06065891
Title: Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer Study Summary: Lymph node metastases are a strong prognostic predictor for pancreatic cancer. Para-aortic lymph nodes (PALN) are the final nodes for periampullary cancers before the cancer cells enter the systemic lymphatic circulation. Some consider these nodes to be regional lymph nodes and dissect them as a part of a routine lymphadenectomy for pancreatic cancer. Others argue that metastases to these nodes represent systemic disease and recommend that radical surgery including extended lymphadenectomy should be abandoned. The aim of this study is to define the incidence and clinical consequences of PALN metastasis in patients submitted to a tentative curative resection for carcinoma of the head of the pancreas by systematically resecting paraaortic lymph nodes. Primary outcome # To determine incidence of PALN metastasis in patients submitted to a tentative curative resection Secondary outcomes # To determine prognosis of patients with PALN metastasis after a curative resection # To determine incidence of metastasis in reginal lymph nodes in patients submitted to a tentative curative resection. # To determine prognosis of patients with metastasis in regional lymph nodes in patients submitted to a tentative curative resection. # To address the question of how to optimize the frozen section analyses of PALN as related to the final pathology report. 300 patients are planned to be included in the trial. Sponsor: Jon Unosson Intervention: PALN resection Start Date: 2023-09-05 Last Updated: 2023-10-04 Number of Patients: 300 Recruitment Status: RECRUITING Condition: Pancreas Cancer
NCTID: NCT03326791
Title: Aspirin in Colorectal Cancer Liver Metastases Study Summary: The ASAC trial is a Scandinavian, multi-center, double-blinded, randomized, placebo-controlled study to determine whether adjuvant treatment with low-dose acetylsalicylic acid (ASA) can improve disease free survival in patients treated with resection for colorectal cancer liver metastases (CRCLM). Several studies have shown beneficial effect of ASA on primary prevention of CRC and the investigators group and others have shown a potential association of ASA also taken after the diagnosis on CRC survival in registry-based studies (secondary prevention). Up to 800 patients operated for CRCLM will be randomized to Arm#1 ASA 160 mg once daily or Arm#2 Placebo for a period of 3 years or till disease recurrence. The patients will be treated and followed up according to standard of care and the National Guidelines. The ASAC trial will be the first clinical interventional trial to assess the beneficial role of ASA in recurrence of CRC liver metastases and survival. ASA is an inexpensive, well tolerated, and easily accessible drug that will be highly potential as adjuvant drug in secondary prevention of CRC liver metastases if the study shows a beneficial effect. This trial will also investigate the effect of ASA as adjuvant treatment on Health-related Quality of Life and the cost-effectiveness. Sponsor: Oslo University Hospital Intervention: Acetylsalicylic acid Start Date: 2017-12-15 Last Updated: 2022-10-21 Number of Patients: 466 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Colorectal Cancer Liver Metastases
NCTID: NCT04919226
Title: Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE Study Summary: The purpose of the study is to evaluate the efficacy, safety & patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin. Sponsor: ITM Solucin GmbH Intervention: 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT Start Date: 2021-12-21 Last Updated: 2023-09-13 Number of Patients: 202 Recruitment Status: RECRUITING Condition: Neuroendocrine Tumors
NCTID: NCT04586517
Title: Effect of Heavy-load Resistance Training During Chemotherapy on Muscle Cellular Outcomes Study Summary: (Neo-)adjuvant chemotherapy for breast cancer is known to have a negative impact on muscle tissue resulting in reduced aerobic fitness, skeletal muscle mass and strength. Physical exercise during treatment may counteract some of these negative effects. However, the effects of resistance training alone have never been explored. The present study aims to investigate if heavy-load resistance training during (neo-)adjuvant chemotherapy counteracts negative effects on skeletal muscle in women diagnosed with breast cancer. The hypothesis is that (neo-)adjuvant treatment with chemotherapy will reduce muscle fiber size, impair mitochondrial function and increase indicators of cellular stress and that resistance training during treatment will counteract these negative effects. Fifty women recently diagnosed with breast cancer scheduled to start (neo-)adjuvant chemotherapy will be randomized to either an intervention group or a control group. The intervention group will perform supervised heavy-load resistance training twice a week over the course of chemotherapy (approximately 16-weeks) whereas the control group will be encouraged to continue with their usual activities. To increase interest in participation, controls will be invited to a 2-week introduction to the same resistance-training program as the intervention group following completion of chemotherapy. Muscle biopsies from m. vastus lateralis will be collected before the first cycle of chemotherapy, after chemotherapy, and 6 months later (6-month follow-up) for assessment of muscle cellular outcomes. Results from this intervention will provide further knowledge on how chemotherapy affects muscle tissue and how resistance training may counteract immediate and long-term treatment side effects. Results from this intervention will also contribute with knowledge about how to improve exercise programs that are effective for women undergoing chemotherapy against breast cancer. Sponsor: Uppsala University Intervention: Heavy-load resistance training Start Date: 2018-12-05 Last Updated: 2022-11-02 Number of Patients: 40 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer Female
NCTID: NCT05900206
Title: Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer Study Summary: The goal of this clinical trial is to compare trastuzumab deruxtecan (T-DXd) to standard preoperative treatment in patients with non-metastatic HER2-positive breast cancer. The main questions it aims to answer are: * is T-DXd more effective than standard preoperative treatment? * are there markers in the tumor or blood of patients with HER2-positive breast cancer that can help us predict response to treatment? Participants will be divided into two groups, where one group will be treated with three courses of T-DXd and the other group will be treated with three courses standard of care treatment. Thereafter, further treatment will be decided by the tumor’s molecular subtype. Sponsor: Karolinska University Hospital Intervention: Trastuzumab deruxtecan Start Date: 2023-10-09 Last Updated: 2023-10-10 Number of Patients: 370 Recruitment Status: RECRUITING Condition: 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: NCT02016391
Title: Effects of Dexmedetomidine During Radiofrequency Ablation of Abdominal Tumours Study Summary: The purpose of he study is to evaluate effects of dexmedetomidine on pain during radiofrequency ablation of liver and kidney tumours. Sponsor: Uppsala University Hospital Intervention: Dexmedetomidine Start Date: 2013-12 Last Updated: 2014-12-17 Number of Patients: 50 Recruitment Status: COMPLETED Condition: Cancer of Kidney and Renal Pelvis
NCTID: NCT00003771
Title: Hormone Replacement Therapy and the Risk of Breast Cancer Recurrence in Women With Previous Early Stage Breast Cancer Study Summary: RATIONALE: Hormone replacement therapy is effective for relieving symptoms of menopause. It is not yet known if hormone replacement therapy increases the risk of breast cancer recurrence in women previously treated for early stage breast cancer. PURPOSE: Randomized phase III trial to determine the risk of breast cancer recurrence in women with previous early stage breast cancer who are receiving hormone replacement therapy for menopause symptoms. Sponsor: Regional Oncologic Center Intervention: therapeutic estradiol Start Date: 1997-09 Last Updated: 2013-09-20 Number of Patients: 1300 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT03556839
Title: Platinum Chemotherapy Plus Paclitaxel With Bevacizumab and Atezolizumab in Metastatic Carcinoma of the Cervix Study Summary: The study will integrate the efficacy of combining the anti programmed death-ligand 1 (anti-PD-L1) agent atezolizumab with the current standard of care in Stage IVB , persistent or recurrent carcinoma of the cervix, namely cisplatin or carboplatin/paclitaxel/bevacizumab. It will be explored the combination of bevacizumab plus atezolizumab, with no patient selection based on PD-L1 expression, allowing an all-comer assessment of atezolizumab activity. The study is a randomized open label phase III trial to investigate the impact of atezolizumab in combination with bevacizumab and cisplatin or carboplatin /paclitaxel chemotherapy on overall survival and will employ the intent to treat principle, and random assignment to one of the 2 arms will be balanced according to disease histology (squamous cell carcinoma vs adenocarcinoma), prior platinum therapy as a radiation sensitizer (no prior cis-Radiotherapy (RT) versus prior cis-RT) and chemotherapy backbone (cisplatin vs carboplatin). This trial will be run in an open label design due to the following considerations: the control arm is the standard of care for women diagnosed with metastatic, persistant or recurrent cervical cancer because of its impact on overall survival and the primary endpoint of the study is overall survival (OS), so blinding is not needed to ensure a robust assessment. Sponsor: Grupo Español de Investigación en Cáncer de Ovario Intervention: Atezolizumab Start Date: 2018-09-25 Last Updated: 2023-09-13 Number of Patients: 404 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma of the Cervix, Stage IVB
NCTID: NCT00399009
Title: Comparative Study of Circular Stapling Instruments Study Summary: After removing the rectum at surgery, bowel continuity can sometimes be restored by an anastomosis between the anus and the bowel. This anastomosis is most commonly created by the use of surgical circular stapling instruments. In a retrospective pilot study the risk of developing an acute leak in the anastomosis was increased with one of the most commonly used instruments in Sweden as compared to the other brand in use. In the current study the patient is randomized to either one of the instruments after a resection of the rectum for rectal cancer. Sponsor: Uppsala University Hospital Intervention: AutoSuture Premium Plus CEEA/Ethicon Proximate ILS Start Date: 2004-01 Last Updated: 2008-06-09 Number of Patients: 880 Recruitment Status: TERMINATED Condition: Anastomotic Leak
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: 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: NCT01062620
Title: A Dose Escalating Clinical Trial of the IGF-1 Receptor Inhibitor AXL1717 in Patients With Advanced Cancer Study Summary: A dose escalating phase Ia-b clinical trial of the IGF-1 receptor inhibitor AXL1717 in patients with advanced cancer. The objective is to study the safety and pharmacokinetics of AXL1717 and to define an appropriate Phase 2 dose for further studies. This is the first study in man. The study is not designed to show tumor response. Sponsor: Axelar AB Intervention: AXL1717 Start Date: 2008-04 Last Updated: 2011-09-15 Number of Patients: 49 Recruitment Status: COMPLETED Condition: Solid Tumors
NCTID: NCT01650805
Title: Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC) Study Summary: The purpose of this study is to compare the efficacy of ponatinib and imatinib in patients with newly diagnosed chronic myeloid leukemia (CML) in the chronic phase. Sponsor: Ariad Pharmaceuticals Intervention: ponatinib Start Date: 2012-06 Last Updated: 2014-11-17 Number of Patients: 307 Recruitment Status: TERMINATED Condition: Chronic Myeloid Leukemia
NCTID: NCT05794906
Title: A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies Study Summary: Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen <math display="block">PSMA</math> positron emission tomography <math display="block">PET</math>) /computed tomography <math display="block">CT</math>) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat. In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments. The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months. To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a “tracer” that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells. To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy. During the study, the study team will: * take blood and urine samples. * measure PSA and testosterone levels in the blood samples * do physical examinations * check the participants’ overall health * examine heart health using electrocardiogram (ECG) * check vital signs * check cancer status using PSMA PET/CT scans, CT, MRI and bone scans * take tumor samples (if required) * ask the participants if they have medical problems About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants’ health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first. Sponsor: Bayer Intervention: Darolutamide (BAY1841788, Nubeqa) Start Date: 2023-04-03 Last Updated: 2023-11-28 Number of Patients: 750 Recruitment Status: RECRUITING Condition: Biochemically Recurrent Prostate Cancer
NCTID: NCT05043506
Title: European Treatment Patterns and Outcomes Associated With First-Line CDK4/6 Inhibition and Hormonal Therapies Study Summary: A retrospective observational analysis of de-identified data from a multinational medical record review to describe patient characteristics, treatment patterns, and effectiveness of palbociclib + AI as first-line therapy among adult patients with HR+/HER2- advanced breast cancer (ABC) in Europe Sponsor: Pfizer Intervention: Palbociclib + aromatase inhibitor Start Date: 2022-02-08 Last Updated: 2023-08-03 Number of Patients: 2400 Recruitment Status: RECRUITING Condition: Metastatic Breast Cancer
NCTID: NCT02562443
Title: Controlled Study of Rigosertib Versus Physician’s Choice of Treatment in MDS Patients After Failure of an HMA Study Summary: The study’s primary objective <math display="block">in a population of patients with MDS after failure of treatment with azacitidine (AZA) or decitabine (DAC)</math>, is to compare the overall survival (OS) of patients in the rigosertib group vs the Physician’s Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk. Sponsor: Onconova Therapeutics, Inc. Intervention: rigosertib Start Date: 2015-12-02 Last Updated: 2022-09-26 Number of Patients: 372 Recruitment Status: TERMINATED Condition: Myelodysplastic Syndrome
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: 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: 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: NCT00383695
Title: Oxaliplatin, Capecitabine, and Radiation Therapy With or Without Cetuximab in Treating Patients Undergoing Surgery for High-Risk Rectal Cancer Study Summary: RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy and radiation therapy with or without cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether giving oxaliplatin, capecitabine, and radiation therapy is more effective with or without cetuximab when given before surgery in treating rectal cancer. PURPOSE: This randomized phase II trial is studying oxaliplatin, capecitabine, and radiation therapy to compare how well they work with or without cetuximab in treating patients undergoing surgery for high-risk rectal cancer. Sponsor: Royal Marsden NHS Foundation Trust Intervention: cetuximab Start Date: 2005-09 Last Updated: 2010-01-13 Number of Patients: 164 Recruitment Status: UNKNOWN Condition: Colorectal Cancer
NCTID: NCT01596114
Title: European Stop Tyrosine Kinase Inhibitor Study Study Summary: The EURO-SKI is a multicenter open label, uncontrolled trial estimating the persistence of molecular remission in Chronic Myeloid Leukemia (CML) patients after stopping Tyrosine Kinase Inhibitor (TKI). Main goal is the assessment of the duration of major molecular response (MMR) or better after stopping TKI therapy. Secondary goals include: * Identification of clinical and biological factors affecting the persistence of complete molecular remission after stopping TKI (e.g. level of Complete molecular remission (CMR), risk score, duration of TKI treatment, type of TKI pretreatment) * Evaluation of quality of life (QoL) in patients stopping TKI * Evaluation of medico-economic impact of stopping TKI * Estimating the number of patients in CMR who are eligible for stopping TKI therapy by setting up a screening log * Time to recovery of CMR There will be no randomised comparison. Based on the experience of the STIM trial (Mahon et al., Lancet Onc 2010) we expect an overall six-month molecular-relapse-free survival probability of at least 40%. An interim analysis will be performed after a pilot phase where 200 patients have been observed for at least six months. Formally, it is planned to test the null hypothesis H0: Six-month molecular relapse-free survival probability P ≤ 40% against the alternative hypothesis H1: Six-month molecular-relapse-free survival probability P > 40%. Eligible are adult CML patients in chronic phase on TKI treatment in CMR for at least one year (> 4 log reduction of BCR-ABL transcripts on IS, TKI treatment for at least 3 years, confirmed by a PCR within a standardized CMR laboratory). Clinical and biological monitoring will be performed during 3 years: Associated scientific projects are performed. Recruitment period: 2 years; follow up: 3 years. Planned patient recruitment in main phase: n=500 Sponsor: European LeukemiaNet Intervention: Stopping treatment with TKI Start Date: 2012-05-30 Last Updated: 2021-11-05 Number of Patients: 868 Recruitment Status: COMPLETED Condition: Chronic Myeloid Leukemia
NCTID: NCT01790230
Title: LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection Study Summary: A preliminary Study in Subjects Undergoing Low Anterior Resection Sponsor: LifeBond Ltd. Intervention: LifeSeal™ Kit Start Date: 2013-01 Last Updated: 2013-09-04 Number of Patients: 10 Recruitment Status: COMPLETED Condition: Rectal Cancer
NCTID: NCT00997048
Title: Comparison Between Laying Open and Sinus Excision of Pilonidal Sinus - a Randomized Study Study Summary: A pilonidal sinus is a cyst or abscess near or on the natal cleft of the buttocks that often contains hair and skin debris. The condition is common and requires surgery to be cured. Several surgical procedures are described in literature. The most common surgical procedure in Sweden is excision of the sinus followed by suturing the subcutaneous tissue and skin. This method, however, has some problems regarding healing and recidives. Therefore this study is comparing the standard excision procedure to another surgical procedure, laying open. Healing frequency is the main variable, but postoperative pain, sick leave time and patient satisfaction is also measured. Sponsor: Uppsala University Intervention: Laying open Start Date: 2002-10 Last Updated: 2009-10-16 Number of Patients: 80 Recruitment Status: COMPLETED Condition: Pilonidal Sinus
NCTID: NCT05985551
Title: Delayed SLND for Patients With Breast Cancer Undergoing Primary Systemic Treatment Study Summary: The goal of this study was to assess the feasibility of SLND by superparamagnetic iron oxide nanoparticles (SPIO) in patients with early breast cancer planned for primary systemic therapy (PST) and whether this is affected by the timeframe of SPIO administration. For this, patients with cN0/1 disease planned for PST received radioisotope as per routine on the day of surgery or the day before, and SPIO was injected in an extended timeframe, at any point from the day of surgery to before the induction of PST. The main points to investigate are: # If the SPIO detection rate and concordance to the radiosotope are affected by time of SPIO injection # If the nodal yield and the accuracy of the procedure are affected Sponsor: Uppsala University Intervention: SLND or TAD by the magnetic technique (SPIO) Start Date: 2020-01-01 Last Updated: 2023-08-14 Number of Patients: 114 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT05744219
Title: Improved Recovery by Iron Following Surgery With Blood Loss, the IRIS-trial Study Summary: The aim of the study is to investigate if iv iron formulation improve recovery after surgery with blood loss. Post-operative anaemia is a common debilitating condition after major surgery due to a combination of preoperative iron deficiency anaemia (IDA) and per-operative blood loss. Median blood loss following hepatopancreatobiliary (HPB) and complex aortic surgery typically range between 500-1000 ml. Bioavailability of iron may be a rate limiting factor in erythropoiesis in anaemia secondary to blood loss. For the IRIS trial, it is hypothesized that intravenously (iv) administered Ferric Carboxymaltose after a per-operative blood loss of 400-4000 ml, improves post-operative recovery and reduces the RBC transfusion. Patients scheduled for elective HPB surgery or complex aortic surgery will be screened for eligibility and recruited into the study. By the end of the surgical procedure, if blood loss is estimated to 400-4000 ml, the patient is randomized 1:1 to iv 1000 mg Ferric Carboxymaltose or placebo. The primary endpoint is a composite of death, number of RBC transfusions, post-operative severe anemia (Hb <80 g/L) and FACT-An Quality of life (QoL) five weeks after surgery, assessed by win ratio. The trial will also examine effects on; a) levels of Hb; b) markers of erythropoiesis and iron bioavailability; c) post-operative complications; d) post-operative recovery; e) performance status; f) subgroups based on type of surgery and degree of anemia and iron deficiency; g) re-admissions; h) long term outcome based on patient medical records and i) how post-operative recovery differs between those with low (<400 ml), high (400-4000 ml) and very high (>4000 ml) per-operative blood loss. Recruitment will continue until 338 patients are randomized or 304 have completed the five week follow up The coordinating center of the trial is the Department of Surgery at Uppsala University Hospital. Participating sites are also Linköping University Hospital and Lund University Hospital, all in Sweden. Other sites may be added. Sponsor: Jon Unosson Intervention: Ferric carboxymaltose Start Date: 2023-08-01 Last Updated: 2023-02-24 Number of Patients: 338 Recruitment Status: NOT_YET_RECRUITING Condition: Surgery
NCTID: NCT04793919
Title: Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia Study Summary: The trial is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who are PCR-positive for the PML-RARα transcript and less than 18 years of age. Sponsor: Associazione Italiana Ematologia Oncologia Pediatrica Intervention: Mylotarg Start Date: 2019-10-09 Last Updated: 2022-08-10 Number of Patients: 89 Recruitment Status: RECRUITING Condition: Acute Promyelocytic Leukemia
NCTID: NCT00182819
Title: Radiation Therapy or Temozolomide in Treating Patients With Gliomas Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective than temozolomide in treating gliomas. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to temozolomide in treating patients with gliomas. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: temozolomide Start Date: 2005-07 Last Updated: 2016-10-12 Number of Patients: 709 Recruitment Status: COMPLETED Condition: Brain and Central Nervous System Tumors
NCTID: NCT00891748
Title: Safety Study on AdCD40L Gene Therapy for Bladder Cancer Study Summary: The study objective is to evaluate the feasibility of three instillations of immunostimulating gene therapy (AdCD40L) in patients with urinary bladder cancer. Tolerance, toxicity and immunological parameters will be evaluated during and post treatment. Sponsor: Uppsala University Intervention: AdCD40L Start Date: 2006-11 Last Updated: 2010-01-18 Number of Patients: 12 Recruitment Status: COMPLETED Condition: Bladder Cancer
NCTID: NCT04144842
Title: Phase 1 Study in Patients With Advanced Solid Malignancies to Evaluate the Safety of ATOR-1017 Study Summary: The aim of the study is to assess the safety and tolerability of increasing doses of ATOR-1017 when administered as repeated intravenous infusions to patients with advanced and/or refractory solid malignancies. Sponsor: Alligator Bioscience AB Intervention: ATOR-1017 Start Date: 2019-12-03 Last Updated: 2023-04-24 Number of Patients: 27 Recruitment Status: COMPLETED Condition: Solid Tumor
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: NCT00852566
Title: Randomized Study Comparing the Effect of Dasatinib and Imatinib on Malignant Stem Cells in Chronic Myeloid Leukemia Study Summary: A randomized multi-center study comparing the effect of dasatinib and imatinib on malignant stem cells in newly diagnosed chronic phase chronic myeloid leukemia (CML) patients. The research hypothesis is that treatment with dasatinib 100 mg daily (QD) results in greater and more rapid depletion of the Philadelphia (Ph) -positive stem cell pool within 6 months of therapy than imatinib 400 mg QD in newly diagnosed CML patients. The study duration is 18 months and approximately 40 patients will be recruited to the study. Sponsor: Norwegian University of Science and Technology Intervention: Imatinib Start Date: 2009-03 Last Updated: 2017-09-25 Number of Patients: 46 Recruitment Status: COMPLETED Condition: Chronic Myeloid Leukemia
NCTID: NCT04252560
Title: The Impact of Gut Microbiota in Anastomoses Insufficiency After Resection and Direct Anastomosis for Colorectal Cancer. Study Summary: The role of gut microbiota in anastomosis insufficiency in patients operated for colorectal cancer and for peritoneal carcinomatosis is going to be investigated. This is a pilot study. Sponsor: Uppsala University Hospital Intervention: Colectomy, CRS+HIPEC Start Date: 2020-01-31 Last Updated: 2022-06-09 Number of Patients: 45 Recruitment Status: RECRUITING Condition: Colorectal Cancer, Peritoneal Carcinomatosis, Anastomosis Insufficiency
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: NCT01866553
Title: Nilotinib Plus Pegylated Interferon-α2b in CML Study Summary: The purpose of this trial is to assess the effect of switching CML patients, who have been treated with imatinib ≥ 2 years and who have stable detectable molecular residual disease between 0.01-1.0% (IS), to the combination of Nilotinib and PegIFN, in terms of the proportion of patients who achieve confirmed MR4.0. Sponsor: Amsterdam UMC, location VUmc Intervention: Nilotinib Start Date: 2013-04 Last Updated: 2018-10-12 Number of Patients: 20 Recruitment Status: TERMINATED Condition: Chronic Myeloid Leukemia
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: 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: NCT06115629
Title: Surveillance After Resection of Oesophageal aNd Gastric Cancer (SARONG-II) Trial
Study Summary: Cancer of the food pipe (oesophagus) and stomach are increasingly common. Currently, most patients with cancer of the oesophagus and stomach are treated with surgery with or without additional chemotherapy or radiotherapy. In recent years there have been improvements in survival from these two cancers, due to better therapies, less invasive surgery and earlier detection. Despite these improvements, in around half of patients treated with surgery, the cancer will return, usually within the first three years. At present there is very little evidence as to how patients who have been treated for cancer of the oesophagus or stomach should be followed up after surgery and whether different methods of follow-up could improve survival. Currently, national and international guidelines do not provide consistency in their recommendations for follow-up after surgery. The SARONG-II study will investigate if regular radiological scans can lead to earlier detection of a cancer returning, at a stage when it may be more readily treatable. This means that participants who agree to take part will be allocated by chance to either more intensive imaging surveillance (including regular radiological scans and a camera test (endoscopy)) or clinical follow-up. The study aims to recruit at least 952 participants in Europe over a 32-month period. Patients undergoing surgery for oesophageal or stomach cancer will be invited to participate in the study at around 4 to 8 weeks after their surgery.
- The imaging surveillance group will receive a review in clinic or by telephone with a member of the surgical team, and a radiological scan at 6, 12, 18, 24, 30 and 36 months after randomisation. They will also receive endoscopy at 12 months after randomisation (ii) The clinical surveillance group will receive a review in clinic or by telephone at 6, 12, 18, 24, 30 and 36 months. After this they will be either discharged to their local doctor or receive a review in clinic with a member of the surgical team every year according to local practice
The main aim of this study will be to determine whether earlier detection of cancer through more intensive follow-up results in improved survival and better quality of life for patients with oesophagus or stomach cancer. The investigators anticipate the results of the study may have significant practice-changing impact for patients undergoing follow-up after surgery for oesophagus and stomach cancer.
Sponsor: University of Dublin, Trinity College Intervention: Surveillance protocol Start Date: 2023-11 Last Updated: 2023-11-03 Number of Patients: 952 Recruitment Status: NOT_YET_RECRUITING Condition: Esophageal 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: 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: NCT02749331
Title: Study of Recombinant Adenovirus AdVince in Patients With Neuroendocrine Tumors; Safety and Efficacy Study Summary: An open-labelled, uncontrolled, single-center Phase I/IIa clinical study to evaluate the safety of repeated infusions of AdVince into the hepatic artery in patients with metastatic neuroendocrine tumors (NETs), and if possible determination of maximum tolerated dose. Sponsor: Uppsala University Intervention: AdVince Start Date: 2016-03 Last Updated: 2021-11-05 Number of Patients: 35 Recruitment Status: RECRUITING Condition: Neuroendocrine Tumors
NCTID: NCT06044623
Title: Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4/6-inhibitors in Older Breast Cancer Patients Study Summary: IMPORTANT study is a multicenter, open-label, prospective, randomized-controlled, non-inferiority trial with a pragmatic approach involving older patients (≥ 70 years old) with advanced hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer, not amenable for curative treatment and without prior therapy for advanced disease, who are suitable to receive CDK 4/6-inhibitors plus endocrine therapy as first line therapy. The study implements two approaches with high level of evidence, namely the use of comprehensive geriatric assessment (CGA) approach in treatment decision making and the use of CDK 4/6-inhibitors as the initial treatment of choice, to investigate whether a common clinical practice (starting dose reduction of CDK 4/6-inhibitors in older patients) with evidence of low certainty can be standardized using a more individualized-based approach. On the basis of baseline CGA assessment, patients will either receive full dose of CDK 4/6-inhibitors plus endocrine therapy (if patients are fit according to CGA) or be randomized to full dose vs. reduced initial dose of CDK 4/6-inhibitors (if vulnerable or frail according to CGA). The study hypothesis is that adjusting the dose according to vulnerability will allow patients to tolerate treatment better without jeopardizing the treatment efficacy. This project has received funding from the European Union’s HORIZON 2022 research and innovation actions supporting the implementation of the Mission on Cancer under grant agreement No 101104589. Sponsor: Region Örebro County Intervention: CDK 4/6 inhibitors Start Date: 2023-11 Last Updated: 2023-10-27 Number of Patients: 495 Recruitment Status: NOT_YET_RECRUITING Condition: Metastatic Breast Cancer
NCTID: NCT01789658
Title: Cryotherapy for Prevention of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation Study Summary: Oral mucositis (OM) is a common adverse effect of chemotherapy, radiotherapy and conditioning regimens before Hematopoietic Stem Cell Transplantation (HSCT). The aim of this study is to effectiveness of cryotherapy as a prophylactic treatment in children undergoing HSCT. Sponsor: Uppsala University Intervention: Cryotherapy Start Date: 2012-10 Last Updated: 2016-10-27 Number of Patients: 53 Recruitment Status: COMPLETED Condition: Oral Mucositis
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: 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: NCT01524094
Title: Cytoreduction and Intraperitoneal Chemotherapy Versus Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis Study Summary: The purpose of this study is to see if there is a difference in survival between two different treatment strategies for colorectal peritoneal surface disease. The control arm administered the currently considered standard treatment which is palliative systemic chemotherapy. The experimental arm received the combination treatment cytoreductive surgery and intraperitoneal chemotherapy. The investigators hypothesis is that the combination treatment will improve the overall survival. Sponsor: Uppsala University Intervention: Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin) Start Date: 2003-06 Last Updated: 2012-02-01 Number of Patients: 49 Recruitment Status: COMPLETED Condition: Colorectal Peritoneal Carcinomatosis
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: 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: NCT03061812
Title: Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE) Study Summary: The purpose of this randomized, open-label, 2-arm, phase 3 study is to assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic SCLC with high levels of DLL3, who have first disease progression during or following front-line platinum-based chemotherapy. Sponsor: AbbVie Intervention: Rovalpituzumab tesirine Start Date: 2017-04-11 Last Updated: 2021-02-23 Number of Patients: 444 Recruitment Status: COMPLETED Condition: Small Cell Lung Cancer
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: NCT01808573
Title: A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting Study Summary: This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting. Sponsor: Puma Biotechnology, Inc. Intervention: neratinib Start Date: 2013-03-29 Last Updated: 2021-06-11 Number of Patients: 621 Recruitment Status: COMPLETED Condition: HER2+ Metastatic Breast Cancer (MBC)
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: NCT00498836
Title: Multicentre, Dose Finding, Ph II,CP-4055 in Comb. With Sorafenib - Patients With Metastatic Malignant Melanoma Study Summary: Patients with metastatic malignant melanoma will receive CP-4055 200 mg/m2/day intravenously (IV) on Day 1-5 every four weeks and sorafenib 400 mg b.i.d. (twice daily) every day until complete response or disease worsening/progressing. Sponsor: Clavis Pharma Intervention: CP-4055 Start Date: 2007-03 Last Updated: 2013-09-12 Number of Patients: 18 Recruitment Status: COMPLETED Condition: Malignant Melanoma
NCTID: NCT03376672
Title: Ixazomib Plus Lenalidomide Plus Dexamethasone for Newly Diagnosed Myeloma Patients Study Summary: This study will evaluate the efficacy and safety of 3-drug all-oral combination, ixazomib plus lenalidomide plus dexamethasone (IRd) as induction treatment for autologous stem cell transplantation eligible patients followed by IRd consolidation and risk based maintenance treatment with IR or R alone. Sponsor: Raija Silvennoinen Intervention: Ixazomib Start Date: 2018-05-31 Last Updated: 2023-09-26 Number of Patients: 120 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Multiple Myeloma
NCTID: NCT02379741
Title: ADC-1013 First-in-Human Study Study Summary: The purpose of this study is to determine whether ADC-1013 (an agonistic human monoclonal IgG1 anti-CD40 antibody) is safe and tolerable when administered intratumorally (as repeated injections directly into the tumor tissue) or intravenously (as repeated doses directly into a vein) in patients with advanced solid tumors. Sponsor: Alligator Bioscience AB Intervention: ADC-1013 Start Date: 2015-04 Last Updated: 2017-03-27 Number of Patients: 24 Recruitment Status: COMPLETED Condition: Neoplasms
NCTID: NCT04697628
Title: Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer Study Summary: This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take. Sponsor: Seagen Inc. Intervention: tisotumab vedotin Start Date: 2021-02-22 Last Updated: 2023-11-14 Number of Patients: 556 Recruitment Status: RECRUITING Condition: Cervical Cancer
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: NCT02046278
Title: LifeSeal™ Pilot Study in Subjects Undergoing Circular Stapled Anastomosis Created Within 10 cm of the Anal Verge Study Summary: A Pilot Study in Subjects Undergoing circular stapled anastomosis created within 10 cm of the anal verge. Sponsor: LifeBond Ltd. Intervention: LifeSeal™ Kit Start Date: 2014-01 Last Updated: 2016-08-30 Number of Patients: 70 Recruitment Status: COMPLETED Condition: Rectal Cancer
NCTID: NCT01587378
Title: Metformin to Prevent Late Miscarriage and Preterm Delivery in Women With Polycystic Ovary Syndrome Study Summary: The overall aim of the PregMet 2 Study is to investigate whether metformin prevents late miscarriages and preterm deliveries in PCOS women treated with metformin from first trimester of pregnancy to delivery in a large, randomized, controlled, multi-centre trial setting. The investigators hypothesis is that metformin compared to placebo treatment from the first trimester to term, reduces the prevalence of late miscarriage (gestational week 13-22) and preterm birth (gestational week < 37) in PCOS women diagnosed according to Rotterdam 2003 consensus criteria, with singleton pregnancy. Sponsor: Norwegian University of Science and Technology Intervention: Metformin Start Date: 2012-10 Last Updated: 2019-02-26 Number of Patients: 489 Recruitment Status: COMPLETED Condition: Pregnancy
NCTID: NCT02241564
Title: Malignancies in Transplanted Patients Study Summary: The aim of the project is to improve the overall treatment and outcome of renal, pancreas or liver transplanted patients who have encountered a malignancy by a structured treatment program for diagnosis and treatment of the malignancy, optimization of the immunosuppressive treatment, follow-up and evaluation of the program. Sponsor: Uppsala University Intervention: Referral to a multidisciplinary expert panel at the Uppsala University Hospital after tumor detection Start Date: 2007-11 Last Updated: 2017-10-26 Number of Patients: 95 Recruitment Status: COMPLETED Condition: Neoplasms
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: NCT04098146
Title: Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection Study Summary: Prospective will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ≥ 4 cm secondary to OSSC removal and who require mandibular reconstruction. Sponsor: AO Innovation Translation Center Intervention: Surgical Resection and Reconstruction Start Date: 2022-09-12 Last Updated: 2023-08-15 Number of Patients: 300 Recruitment Status: RECRUITING Condition: Mandibular Reconstruction
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: NCT02316457
Title: RNA-Immunotherapy of IVAC_W_bre1_uID and IVAC_M_uID Study Summary: The Mutanome Engineered RNA Immuno-Therapy (MERIT) study introduces a novel concept for Individualized Cancer Immunotherapy (IVAC®) to treat each patient with the relevant and immunogenic RNA vaccines for a given patient’s tumor. The TNBC-MERIT trial uses two complementary strategies, the WAREHOUSE and the IVAC® MUTANOME concept, resulting in two custom-made IVAC® investigational medicinal products (IMPs) (IVAC_W_bre1_uID and IVAC_M_uID) for each individual patient. Sponsor: BioNTech SE Intervention: IVAC_W_bre1_uID Start Date: 2016-10 Last Updated: 2023-07-19 Number of Patients: 42 Recruitment Status: COMPLETED Condition: Breast Cancer (Triple Negative Breast Cancer (TNBC))
NCTID: NCT02132624
Title: CD19-targeting 3rd Generation CAR T Cells for Refractory B Cell Malignancy - a Phase I/IIa Trial. Study Summary: Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell lymphoma or leukemia. The CAR consists of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy. Sponsor: Uppsala University Intervention: Autologous 3rd generation CD19-targeting CAR T cells Start Date: 2014-04 Last Updated: 2017-10-30 Number of Patients: 15 Recruitment Status: COMPLETED Condition: B Cell Lymphoma
NCTID: NCT04718324
Title: PREMs on PROMs in Breast Disease (PREMs_PROMs) Study Summary: In recent years, large interest in the conduct and focus of clinical trials has focused to patient related outcomes and value-based healthcare. Patient Reported Outcome MeasureS, (PROMs) has become one of the standard instruments used for measuring outcomes; multiple PROMS have been extensively validated and are used in many clinical studies, but also in clinical routine. Additionally, Patient Reported Experience MeasureS (PREMS) allow for real-time feedback on the integration of care and can subsequently drive changes in health provision systems. In the present trial, the mode of delivery of PROMS is examined in terms of effectivity and patient experience (PREMS) in the setting of breast disease. Sponsor: Uppsala University Intervention: e-PROMS Start Date: 2019-09-01 Last Updated: 2021-05-17 Number of Patients: 230 Recruitment Status: COMPLETED Condition: Breast Disease
NCTID: NCT03573596
Title: Persistence of MR3 in Chronic Myeloid Leukemia (CML) After a 2nd Stop of TKI Treatment Study Summary: This study will enroll CML patients who have failed a first TKI stopping attempt. After failure and at least a year of TKI treatment, patients will proceed to dasatinib treatment for another 2 years. If MR4 or better is re-achieved and maintained for at least one year, patients will be eligible for a second stop. After verification of MR4, TKI treatment will be stopped and patients followed in the same manner as after first stop. If MMR is lost (BCR-ABL >0.1% (IS)), TKI treatment will once again be restarted. Sponsor: Amsterdam UMC, location VUmc Intervention: Dasatinib Start Date: 2018-02-01 Last Updated: 2018-06-29 Number of Patients: 134 Recruitment Status: RECRUITING Condition: CML, Relapsed
NCTID: NCT00379457
Title: Combination Chemotherapy in Treating Young Patients With Nonmetastatic Rhabdomyosarcoma Study Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating rhabdomyosarcoma. PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to compare how well they work in treating young patients with nonmetastatic rhabdomyosarcoma. Sponsor: European Paediatric Soft Tissue Sarcoma Study Group Intervention: dactinomycin Start Date: 2006-06 Last Updated: 2013-08-12 Number of Patients: 600 Recruitment Status: UNKNOWN Condition: Sarcoma
NCTID: NCT00454376
Title: Disease-Specific Questionnaire in Assessing Quality of Life in Patients With Gastrointestinal-Related Neuroendocrine Tumors Study Summary: RATIONALE: Questionnaires that measure quality of life may help doctors identify the effects of treatment and improve the ability to plan treatment for patients with gastrointestinal-related neuroendocrine tumors. PURPOSE: This phase IV clinical trial is studying how well a disease-specific questionnaire works in assessing the quality of life of patients with gastrointestinal-related neuroendocrine tumors. Sponsor: National Cancer Institute (NCI) Intervention: questionnaire administration Start Date: 2006-10 Last Updated: 2013-10-29 Number of Patients: 408 Recruitment Status: UNKNOWN Condition: Gastrointestinal Carcinoid Tumor
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: 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: NCT00904813
Title: The Stockholm III Trial on Different Preoperative Radiotherapy Regimens in Rectal Cancer Study Summary: Preoperative radiotherapy (RT) is recommended to many patients with localised rectal cancer, not previously treated with pelvic RT. However, the optimum fractionation, the timing of surgery and the best use of concomitant chemotherapy remains controversial. There are theoretical reasons to believe that radiotherapy given in larger fractions during a shorter period of time might result in more late side effects than giving a conventional, more protracted RT in patients with rectal cancer. In addition, the optimum timing of surgery after RT, with respect to postoperative morbidity, mortality and potential downsizing of the tumour is not known. To address these questions, a prospective randomized multicenter trial was initiated, the Stockholm III trial, in which patients with primarily resectable rectal cancer were randomized to short-course preoperative RT (5x5 Gy) followed by surgery within one week or after 4-8 weeks or long-course preoperative RT(25x2 Gy) followed by surgery after 4-8 weeks. Sponsor: Karolinska Institutet Intervention: Short-course RT Start Date: 1998-11 Last Updated: 2021-05-07 Number of Patients: 840 Recruitment Status: COMPLETED Condition: Rectal Cancer
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: NCT00040599
Title: Safety Study of 90Y-hMN14 to Treat Colorectal Cancer Study Summary: The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in the treatment of colorectal cancer. Sponsor: Gilead Sciences Intervention: hMN14 (labetuzumab) Start Date: 2000-01 Last Updated: 2021-08-19 Number of Patients: 72 Recruitment Status: COMPLETED Condition: Colorectal Cancer
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: NCT02044224
Title: Effects of Dexmedetomidine During IRE Procedures for Solid Tumours Study Summary: The purpose of the study is to evaluate effects of dexmedetomidine on anaesthesia during IRE procedures for solid tumours Sponsor: Uppsala University Hospital Intervention: Dexmedetomidine Start Date: 2014-01 Last Updated: 2015-10-20 Number of Patients: 30 Recruitment Status: COMPLETED Condition: Cancer of Liver
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: NCT00058201
Title: Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic 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 which chemotherapy regimen is more effective, or whether chemotherapy is more effective than observation, in treating pancreatic cancer after surgery. PURPOSE: Phase III trial to compare the effectiveness of two chemotherapy regimens with no further therapy in treating patients who have completely resected pancreatic cancer. Sponsor: Royal Liverpool University Hospital Intervention: fluorouracil Start Date: 2001-07 Last Updated: 2013-12-18 Number of Patients: 1030 Recruitment Status: COMPLETED Condition: Pancreatic Cancer
NCTID: NCT04998734
Title: Validation of the ASI-SR Form in a Population of Chronic Non-cancer Pain Patients Study Summary: The Swedish version of ASI-SR has shown good feasibility in assessment of addiction patients functioning compare to long and time-consuming ASI, which is upp to date golden standard in Sweden. This study investigate if ASI-SR is suitable instrument for the assessment of the chronic pain patient addicted to opioids. The validation process is designed according to the COSMIN guidelines. Preliminary results are expected by December 2022. Sponsor: Uppsala University Intervention: ASI-SR Start Date: 2021-08-05 Last Updated: 2023-05-11 Number of Patients: 1 Recruitment Status: TERMINATED Condition: Chronic Pain
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: NCT00003636
Title: Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining surgery with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy before surgery is more effective than chemotherapy after surgery in treating ovarian, peritoneal, or fallopian tube cancer. PURPOSE: This randomized phase III trial is studying chemotherapy given before surgery to see how well it works compared to chemotherapy given after surgery with or without additional surgery in treating patients with stage III or stage IV ovarian cancer, peritoneal cancer, or fallopian tube cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: carboplatin Start Date: 1998-09 Last Updated: 2015-08-05 Number of Patients: 704 Recruitment Status: COMPLETED Condition: Fallopian Tube Cancer
NCTID: NCT03343236
Title: Nutrition and Inflammation in Patients With Head and Neck Cancer Study Summary: An estimated 1500 people in Sweden will annually be diagnosed with head and neck cancer (HNC). Five year survival is approximately 69%. Long-term sequelae are common and in particular nutritional problems and fatigue. Radiotherapy (RT) is the cornerstone of treatment, either as single modality treatment or combined modality treatment. RT can induce immune responses at the site of tumor. It has been demonstrated that RT can lead to a strong systemic immune response . We have previously shown that an increase of conventional measures of systemic immune response to RT varied significantly across individuals. We predict that local immune response plays a major role in the antitumor effect. We also predict that a strong systemic immune response contributes to malnutrition and influence on survival. And malnutrition may lead to a worse response to RT. The overall aim of this multicenter observational longitudinal study is to prospectively identify immunological and metabolic variables that affect the outcome of HNC patients. We will systematically investigate the local and systemic immune response induced by RT as well as explore alterations in metabolite composition induced by disease and treatment through global metabolite profiling. A platform for studies on immuno-metabolic changes in HNC patients has been established in the Uppsala-Orebro and Northern regions. Approximately 370 patients per year are eligible. Findings in this study can have implications on the development of personalized therapy in patients with HNC. The long-term benefit of the study will be the identification of measures for improved patient surveillance in order to improve the general and nutritional outcomes. Sponsor: Uppsala University Intervention: Radiotherapy Start Date: 2015-11-01 Last Updated: 2022-11-14 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Head and Neck Neoplasms
NCTID: NCT02647099
Title: Adjuvant Low Dose Aspirin in Colorectal Cancer Study Summary: ALASCCA is a randomized, parallel group, double blind, multicenter, placebo-controlled, biomarker-based study of adjuvant treatment with low dose aspirin in patients with colorectal cancer. Hypothesis is that patients diagnosed with colorectal cancer and somatic mutations in PI3K pathway can significantly improve survival if treated with low dose aspirin. Sponsor: Anna Martling Intervention: Acetylsalicylic acid Start Date: 2016-04-07 Last Updated: 2023-10-04 Number of Patients: 600 Recruitment Status: RECRUITING Condition: Colorectal Cancer
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: NCT03033511
Title: A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU) Study Summary: This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy. Sponsor: AbbVie Intervention: Placebo for dexamethasone Start Date: 2017-02-07 Last Updated: 2021-07-29 Number of Patients: 748 Recruitment Status: TERMINATED Condition: Small Cell Lung Cancer
NCTID: NCT04123470
Title: A Phase I/II Trial Investigating LOAd703 in Combination With Atezolizumab in Malignant Melanoma Study Summary: This study aims to evaluate safety and effect of combining an oncolytic adenovirus (delolimogene mupadenorepvec; LOAd703) with atezolizumab in patients with melanoma. LOAd703 will be administered intratumorally for up to 12 injections while atezolizumab will be administered intravenously for the duration of the active study visits (up to 57 weeks). The patients are then monitored for survival for maximum study participation of 48 months. The treatments will be given every 3 weeks. The patients will then be monitored for toxicity, PK, ADA, immune responses, virus shedding, tumor response by RECIST 1.1 and survival. Sponsor: Lokon Pharma AB Intervention: delolimogene mupadenorepvec Start Date: 2020-01-28 Last Updated: 2023-08-29 Number of Patients: 26 Recruitment Status: COMPLETED Condition: Malignant Melanoma
