Trials (Maria Sklodowska- Curie National Research Institute of Oncology)
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NCTID: NCT03517137
Title: Very Early PET-response Adapted Targeted Therapy for Advanced Hodgkin Lymphoma: a Single -Arm Phase II Study Study Summary: The main objective of this trial is to assess whether treatment adaptation based on a very early FDG-PET/CT results in improved efficacy while minimizing treatment toxicity in advanced stage Hodgkin Lymphoma (HL) patients treated with brentuximab vedotin (BV)-containing regimens. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Brentuximab Vedotin Start Date: 2019-08-01 Last Updated: 2023-11-09 Number of Patients: 150 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Advanced Hodgkin Lymphoma
NCTID: NCT04093687
Title: Towards Painless Colonoscopy Study Summary: One of the major barriers to CRC screening participation is a negative perception of colonoscopy as a painful and unpleasant procedure. Previously, by monitoring patient-reported outcomes as one of the colonoscopy quality performance measures, the investigators identified the endoscopist as the single, most important risk factor for painful colonoscopy. Therefore, the investigators propose a randomized controlled trial to analyse the effectiveness of directed training on the endoscopists painful colonoscopy rate. The study will be conducted in two phases: endoscopist categorization and design of training (I) and randomized controlled trial evaluating training effectiveness (II). Phase I will include endoscopists from Polish Colonoscopy Screening Programme (PCSP) willing to participate. Volunteers will be divided into underperformers, average performers and overperformers, based on their painful colonoscopy rate (obtained from PCSP database records) and will be invited to take part in the initial workshop focused on pain reduction during colonoscopy (conducted in a similar fashion to Train Colonoscopy Leaders (TCL) workshop, aiming at ADR improvement). On the basis of the differences in performance between over- and underperformers, categories of importance, target scores and a questionnaire for the assessment of factors for improvement will be developed. In Phase II, endoscopists from PCSP screening centres previously categorized as underperformers and average performers will be randomized in 1:1 ratio either to control (no intervention) or intervention arm. The subjects in the control arm will not be trained or informed about study participation. The endoscopists assigned to the intervention arm will be invited to take part in one training session designed in Phase I of the study (according to the evaluation questionnaire from Phase I). Willing overperformers will be asked to participate in the training as teachers. The training session will be divided into two parts: theoretical - presentation of research on painless colonoscopy - and practical - colonoscopy performance with commentary. Subjects matched 1:1 with trainers will take part in such a session, supervised by the study coordinator. Each endoscopist who underwent training in the second phase of the study will be sent a written, customized feedback on changes after the intervention and information about factors to improve (as per evaluation questionnaire from Phase I of the study). All endoscopists enrolled into Phase II will be followed through PCSP database for the endpoint of painful colonoscopy rate; the intervention arm will be compared with the control group at 6 and 12 months after feedback in order to investigate whether the adjusted painful colonoscopy rate improved as a result of the intervention. Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: Endoscopist’s training Start Date: 2019-11 Last Updated: 2019-09-18 Number of Patients: 64 Recruitment Status: UNKNOWN Condition: Colorectal Cancer
NCTID: NCT04733183
Title: Efficacy and Safety of L19TNF in Previously Treated Patients With Advanced Stage or Metastatic Soft-tissue Sarcoma Study Summary: Open label, randomized, controlled phase II study preceded by a safety run-in part in subjects with advanced or metastatic soft-tissue sarcoma. Sponsor: Philogen S.p.A. Intervention: Dacarbazine Start Date: 2020-08-28 Last Updated: 2023-10-10 Number of Patients: 98 Recruitment Status: RECRUITING Condition: Soft Tissue Sarcoma
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: 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: NCT02500043
Title: Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer Study Summary: The purpose of this trial is to compare the effects of TAS-102 and best supportive care (BSC) with Placebo (an inactive drug) and best supportive care on metastatic gastric cancer. Sponsor: Taiho Oncology, Inc. Intervention: TAS-102 Start Date: 2016-02-24 Last Updated: 2021-09-16 Number of Patients: 507 Recruitment Status: COMPLETED Condition: Refractory Metastatic Gastric Cancer
NCTID: NCT00003643
Title: Combination Chemotherapy in Treating Men With Germ Cell 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 may kill more tumor cells. It is not yet known which regimen of combination chemotherapy may be more effective for germ cell cancer. PURPOSE: This randomized phase II/III trial is studying two different regimens of combination chemotherapy and comparing how well they work in treating men with germ cell cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: bleomycin sulfate Start Date: 1998-10 Last Updated: 2012-03-06 Number of Patients: 498 Recruitment Status: UNKNOWN Condition: Extragonadal Germ Cell Tumor
NCTID: NCT01182922
Title: Information About a Doctor or a Possibility of Choosing Doctor’s Gender and Attendance to Screening Colonoscopy Study Summary: The purpose of the study is to investigate whether the information about a doctor or possibility to choose doctor’s gender included in invitation letter is associated with attendance rate to screening colonoscopy. Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: Invitation letter Start Date: 2010-08 Last Updated: 2011-11-18 Number of Patients: 5100 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT03790475
Title: Participation in Competing Strategies for Colorectal Cancer Screening - a Randomized Health Services Study Within the National Screening Program in Poland Study Summary: The PICCOLINO is a randomized health services study performed within the framework of the Polish Colonoscopy Screening Program (PCSP) in Poland. Within the study 12,298 eligible persons between 55 and 64 years of age will be drawn from the Population Registry and randomly assigned in a 1:1:1 ratio to receive an invitation to participate in one of the three screening strategies: (I) postal invitation to colonoscopy and a re-invitation to colonoscopy for initial non-responders, (II) postal invitation for screening using fecal immunochemical test (FIT) for non-responders and subjects refusing a colonoscopy, or (III) postal invitation offering a choice between FIT and colonoscopy. Colonoscopies will be performed in seven local centers participating in the study. FITs will be analyzed in the central laboratory. Subjects with positive FIT result will be recommended to undergo colonoscopy. The primary outcome is participation with CRC screening within 18 weeks after enrollment, defined as completion of colonoscopy, or completion of FIT along with colonoscopy for positive FIT result. Secondary outcome will be diagnostic yield for advanced neoplasia (CRC or advanced adenoma). The study has been approved by a local bioethics committee. Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: Offering a choice for colorectal cancer screening Start Date: 2018-08-25 Last Updated: 2018-12-31 Number of Patients: 12298 Recruitment Status: UNKNOWN Condition: Colorectal Cancer
NCTID: NCT03816475
Title: Hypofractionated Radiotherapy in Locally Advanced Myxoid Liposarcomas of Extremities or Trunk Wall (LIPO-MYX Trial) Study Summary: After a screening, which consists of pathology confirmation, physical examination, magnetic resonance imaging (MRI), body computed tomography (CT) scan, blood tests, and case analysis on Multidisciplinary Team (MDT) meeting, patient will be irradiated 5x5 Gy and after radiotherapy and then referred for surgery 6-8 weeks after the radiotherapy completion. Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: Hypofractionated radiotherapy Start Date: 2015-04-24 Last Updated: 2019-06-17 Number of Patients: 35 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Myxoid Liposarcoma
NCTID: NCT00005868
Title: Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of docetaxel and cisplatin in treating patients who have untreated stage IIIA non-small cell lung cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: cisplatin Start Date: 2000-03 Last Updated: 2012-07-18 Number of Patients: 47 Recruitment Status: COMPLETED Condition: Lung Cancer
NCTID: NCT05348356
Title: Nirogacestat in Ovarian Granulosa Cell Tumors Study Summary: This phase 2 clinical trial will study the effectiveness of nirogacestat in ovarian granulosa cell tumors (OvGCTs). Nirogacestat is a gamma secretase inhibitor (GSI) which is hypothesized to decrease the growth and activity of ovarian granulosa tumors. Sponsor: SpringWorks Therapeutics, Inc. Intervention: Nirogacestat Start Date: 2022-08-30 Last Updated: 2023-11-22 Number of Patients: 53 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Ovarian Granulosa-Stromal Tumor
NCTID: NCT02831959
Title: Pivotal, Open-label, Randomized Study of Radiosurgery With or Without Tumor Treating Fields (TTFields) for 1-10 Brain Metastases From Non-small Cell Lung Cancer (NSCLC). Study Summary: The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1 inoperable brain metastasis or 2-10 brain metastases, treated with NovoTTF-200M and supportive treatment compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays. Sponsor: NovoCure GmbH Intervention: NovoTTF-200M device Start Date: 2016-07 Last Updated: 2023-03-10 Number of Patients: 270 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Brain Metastases From Non-small Cell Lung Cancer (NSCLC)
NCTID: NCT05155254
Title: IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18) Study Summary: Phase 3, multicenter, international, open-label, randomized, 2-arm trial investigating the safety and efficacy of IO102-IO103 in combination with pembrolizumab as first-line treatment for patients with previously untreated unresectable or metastatic (advanced) melanoma. Patients will be stratified on the basis of the following factors; Disease stage: Stage III (unresectable) and IV M1a-b versus stage IV M1c-d and BRAFV600 mutation status: mutated vs wild type. All patients will receive pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment). Patients randomized to IO102-IO103 dual-antigen, immunotherapeutic arm will also be given IO102-IO103 Q3W with an additional dose given during the induction period on Day 8 of cycles 1 and 2. IO102 IO103 will thereafter be administered subcutaneous every 3 weeks during the maintenance period. Each patient can be treated for a maximum of 37 administrations in total (up to 2 years of treatment). The primary objective is to investigate the efficacy of IO102-IO103 in combination with pembrolizumab (compared with pembrolizumab alone) in terms of progression free survival. Sponsor: IO Biotech Intervention: IO102-IO103 Start Date: 2022-05-17 Last Updated: 2023-09-13 Number of Patients: 380 Recruitment Status: RECRUITING Condition: Metastatic Melanoma
NCTID: NCT06057350
Title: Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR Study Summary: Randomized head-to-head comparison trial among patients who have undergone incomplete endoscopic resection of early colon cancer to evaluate the benefits, harms and burdens, as well as the ecological footprint and cost-effectiveness of endoscopic full thickness resection (eFTR), a minimally invasive endoscopic treatment with a colonoscope, as compared to standard-of-care surgery. Co-primary endpoints are * Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 30-days after study treatment * CRC recurrence or sign of lymph nodes or distant metastases at 3 years after randomization comparing the two treatment groups (eFTR versus surgery). Sponsor: Norwegian Department of Health and Social Affairs Intervention: Tumor removal Start Date: 2023-10-27 Last Updated: 2023-11-13 Number of Patients: 304 Recruitment Status: RECRUITING Condition: Treatment Side Effects
NCTID: NCT05429268
Title: Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND) Study Summary: The purpose of this study is to assess the efficacy and safety of of tafasitamab plus lenalidomide in adults with diffuse large B-cell lymphoma (DLBCL) who have relapsed or are refractory to at least 1 but no more than 3 previous systemic DLBCL treatment regimens and who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). Sponsor: Incyte Corporation Intervention: Tafasitamab Start Date: 2022-12-23 Last Updated: 2023-11-24 Number of Patients: 81 Recruitment Status: RECRUITING Condition: Large B-Cell Lymphoma
NCTID: NCT01561456
Title: Study of AXL1717 Compared to Docetaxel to Treat Squamous Cell Carcinoma or Adenocarcinoma of the Lung Study Summary: The purpose of this study is to compare effectiveness and safety of experimental anticancer medicine, AXL1717, and docetaxel in patients with squamous cell carcinoma or adenocarcinoma of the lung. Sponsor: Axelar AB Intervention: AXL1717 Start Date: 2011-12 Last Updated: 2013-12-05 Number of Patients: 100 Recruitment Status: COMPLETED Condition: Non-small-cell Lung Cancer
NCTID: NCT04258956
Title: A Study of Avelumab In Combination With Axitinib in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumor After Failure of Standard Therapy Study Summary: To assess anti-tumor activity of avelumab in combination with axitinib in patients with unresectable/metastatic GIST after progression on second or third line treatment (after failure on at least of imatinib and sunitinib) in terms of progression-free survival (PFS) Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: Axitinib Start Date: 2019-04-30 Last Updated: 2020-02-06 Number of Patients: 58 Recruitment Status: UNKNOWN Condition: Gastrointestinal Stromal Tumors
NCTID: NCT01880359
Title: AF CRT +/- Nimorazole in HNSCC Study Summary: The drug nimorazole belongs to a class of chemicals known as 5-nitroimidazoles. Drugs from this class are used against infection. In addition, nimorazole makes tumor cells more sensitive to radiotherapy. Therefore, the investigators want to find out whether the addition of nimorazole to the standard treatment with radiotherapy in combination with chemotherapy with cisplatin shows activity against your type of head and neck cancer and is safe. Furthermore the investigators will investigate if a specific examination done with your tumor tissue will help to predict whether the treatment will work or not. To find out if the activity observed with this treatment is not caused by chance alone, the investigators need to obtain data from patients who receive this treatment and from patients who receive other treatments. The data from these two groups of patients will be compared to see which treatment is better. Participants will be split into 2 groups. Each group will receive different treatments. The treatment each group receives is determined by chance using a computer program. This works like flipping a coin and is called randomization. This helps to make sure that groups of patients are similar when the study starts. Neither you, your study doctor, nor the study staff can influence in which group you will be placed or which treatment you will receive. If allocated to group 1, Patient will receive radiotherapy in combination with chemotherapy with cisplatin and nimorazole as a pill. This is considered the ‘experimental’ treatment. If allocated to group 2, patient will receive radiotherapy in combination with chemotherapy with cisplatin and a so called ‘placebo’ as a pill. The placebo is a dummy treatment. It looks like the real one, but it is not. It contains no active ingredient/medicine. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Cisplatin Start Date: 2014-07-25 Last Updated: 2022-05-10 Number of Patients: 640 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Locally Advanced Head and Neck HPV Negative Squamous Cell Cancers
NCTID: NCT00002503
Title: Strontium Compared With Radiation Therapy in Treating Patients With Hormone-Refractory Prostate Cancer With Painful Bone Metastases Study Summary: RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. This may be an effective treatment for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of strontium or radiation therapy in treating patients with prostate cancer that is refractory to hormone therapy who have painful bone metastases. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: strontium chloride Sr 89 Start Date: 1992-10 Last Updated: 2012-09-24 Number of Patients: 204 Recruitment Status: COMPLETED Condition: Metastatic Cancer
NCTID: NCT03443856
Title: Postoperative Immunotherapy vs Standard Chemotherapy for Gastric Cancer With High Risk for Recurrence Study Summary: The primary objective of the trial is to investigate if nivolumab plus ipilimumab given as adjuvant treatment improve disease free survival (DFS) in patients with stage Ib-IVa gastric and esophagogastric junction adenocarcinoma and high risk of recurrence (defined by ypN1-3 and/or R1 status) following neoadjuvant chemotherapy and resection. Other study objectives: * To investigate the safety and effect of adjuvant immunotherapy on long term oncologic outcomes and quality of life of patients in the study * To correlate nutritional status assessment on outcomes and quality of life of patients Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Nivolumab and Ipilimumab Start Date: 2019-07-17 Last Updated: 2023-09-07 Number of Patients: 197 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Gastric and Esophagogastric Junction Adenocarcinoma
NCTID: NCT03609047
Title: Adjuvant Palbociclib in Elderly Patients With Breast Cancer Study Summary: Phase II study to assess the efficacy of the combination of at least 5 year endocrine therapy and 2 year-palbociclib as adjuvant systemic treatment instead of adjuvant chemotherapy followed by endocrine therapy in older patients with stage II-III ER+/HER2- early breast cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Palbociclib Start Date: 2019-06-14 Last Updated: 2022-11-17 Number of Patients: 366 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer Stage II
NCTID: NCT01234025
Title: Safety and Tolerability Study of ISIS EIF4E Rx in Combination With Docetaxel and Prednisone (CRPC) Study Summary: The purpose of this study is to examine the safety, tolerability and progression-free survival of patients with Castrate-Resistant Prostate Cancer treated with ISIS EIF4E Rx in combination with docetaxel and prednisone. Sponsor: Ionis Pharmaceuticals, Inc. Intervention: ISIS EIF4E Rx Start Date: 2010-11 Last Updated: 2023-10-06 Number of Patients: 113 Recruitment Status: COMPLETED Condition: Castrate-Resistant Prostate Cancer
NCTID: NCT04634825
Title: Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer Study Summary: This is a Phase 2 study of enoblituzumab combined with either retifanlimab or tebotelimab administered as first-line treatment to patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Sponsor: MacroGenics Intervention: Enoblituzumab Start Date: 2021-03-17 Last Updated: 2022-11-07 Number of Patients: 62 Recruitment Status: TERMINATED Condition: Head and Neck Cancer
NCTID: NCT02227251
Title: Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Study Summary: A multicenter, open-label Phase 2b study of selinexor (KPT-330) in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have no therapeutic options of demonstrated clinical benefit. Sponsor: Karyopharm Therapeutics Inc Intervention: Selinexor Start Date: 2014-11 Last Updated: 2023-08-07 Number of Patients: 244 Recruitment Status: RECRUITING Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT01200992
Title: Efficacy and Safety Evaluation of EN3348 (Mycobacterial Cell Wall-DNA Complex [MCC]) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent/Refractory Non-muscle Invasive Bladder Cancer Study Summary: This is a phase 3 randomized, active-controlled, open-label, multicenter study that will be conducted in approximately 120 investigational sites worldwide. Subjects with either recurrent or refractory NMIBC (Ta high grade, T1 low or high grade, CIS) will be eligible for participation in this study. Refractory disease is defined as evidence of persistent high grade bladder cancer (Ta HG, T1, and/or CIS) at least 6 months from the start of a full induction course of BCG with or without maintenance/re-treatment at 3 months. Recurrent disease is defined as reappearance of disease after achieving a tumor-free status by 6 months following a full induction course of BCG with or without maintenance/re-treatment at 3 months. Subjects with recurrent disease must have recurred within 18 months following the last dose of BCG. Approximately 450 subjects will be randomized. The primary objective of this study is to evaluate the efficacy of intravesical EN3348 as compared with mitomycin C in the treatment of subjects with recurrent or refractory NMIBC. The secondary objective is to evaluate the safety of EN3348 as compared with mitomycin C in the treatment of subjects with BCG recurrent or refractory NMIBC. This study will consist of 4 phases: Screening, Induction, Maintenance and Follow-Up and will be conducted over 3 years. Sponsor: Bioniche Life Sciences Inc. Intervention: EN3348 Start Date: 2010-11 Last Updated: 2017-08-24 Number of Patients: 84 Recruitment Status: TERMINATED Condition: Bladder Neoplasm
NCTID: NCT05052255
Title: RVU120 (SEL120) in Patients With Relapse/Refractory Metastatic or Advanced Solid Tumors Study Summary: This is a phase 1/2, dose-escalation and expansion study investigating the safety, pharmacokinetics, and efficacy of RVU120 (SEL120) in patients with metastatic or advanced solid tumors progressing from previous lines of therapy. Sponsor: Ryvu Therapeutics SA Intervention: RVU120 Start Date: 2021-08-13 Last Updated: 2022-12-09 Number of Patients: 120 Recruitment Status: RECRUITING Condition: Advanced Solid Tumor
NCTID: NCT00003212
Title: Ifosfamide or Doxorubicin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma 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 whether ifosfamide or doxorubicin is more effective for advanced or metastatic soft tissue sarcoma. PURPOSE: Randomized phase III trial to compare the effectiveness of ifosfamide with that of doxorubicin in treating patients who have advanced or metastatic soft tissue sarcoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: doxorubicin hydrochloride Start Date: 1998-01 Last Updated: 2012-01-20 Number of Patients: 780 Recruitment Status: COMPLETED Condition: Sarcoma
NCTID: NCT01633333
Title: Water Exchange Versus Carbon Dioxide for Colonoscopy Study Summary: Colonoscopy is commonly used in screening for colorectal cancer. A refined technique of colonoscopy involving the use of water as the sole modality to aid colonoscope insertion, water exchange, has been described in recent research papers to decrease patient discomfort and pain, and to reduce the need for sedation during colonoscopy when compared with standard air insufflation. Carbon dioxide insufflation has been described to decrease patient discomfort after colonoscopy. No randomized trial has so far compared the use of water exchange to carbon dioxide insufflation. Our hypothesis is that water exchange inflicts less discomfort to patients undergoing colonoscopy than carbon dioxide insufflation. Patients undergoing screening colonoscopy in two centers in Norway, one center in Poland and one center in The Netherlands will be enrolled and randomized to examination of either of the two methods. Sponsor: Sorlandet Hospital HF Intervention: Water exchange colonoscopy Start Date: 2012-06 Last Updated: 2014-02-12 Number of Patients: 473 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT02722733
Title: Randomized Trial of G-CSF Alone Versus Intermediate-dose Ara-C Plus G-CSF Mobilization in Hodgkin’s Lymphoma or Non-Hodgkin’s Lymphoma Study Summary: The purpose of the study is to compare safety and efficacy of stem cell mobilization using G-CSF (filgrastim) alone vs. intermediate-dose cytosine arabinoside plus G-CSF in Hodgkin’s lymphoma and non-Hodgkin’s lymphoma patients. Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: G-CSF (filgrastim) Start Date: 2016-03 Last Updated: 2016-03-30 Number of Patients: 90 Recruitment Status: UNKNOWN Condition: Hodgkin’s Lymphoma
NCTID: NCT04656652
Title: Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01) Study Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) with or without actionable genomic alterations. Sponsor: Daiichi Sankyo, Inc. Intervention: DS-1062a Start Date: 2020-12-21 Last Updated: 2023-11-18 Number of Patients: 590 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer
NCTID: NCT03235245
Title: Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib Study Summary: This is a multicenter, 2-arm open-label, randomized comparative phase II study. The objective of this trial is to prospectively evaluate whether a sequential approach with an induction period of 12 weeks with encorafenib + binimetinib followed by combination immunotherapy with nivolumab + ipilimumab improves progression free survival compared to combination immunotherapy nivolumab + ipilimumab alone in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Nivolumab + Ipilimumab Start Date: 2018-10-30 Last Updated: 2023-11-03 Number of Patients: 271 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Unresectable Stage III Melanoma
NCTID: NCT04871282
Title: A Study of AL102 in Patients With Progressing Desmoid Tumors Study Summary: The current study is designed to evaluate the efficacy and safety of AL102 in patients with progressive desmoid tumors. Sponsor: Ayala Pharmaceuticals, Inc, Intervention: AL102 Start Date: 2021-03-30 Last Updated: 2023-11-24 Number of Patients: 192 Recruitment Status: RECRUITING Condition: Desmoid
NCTID: NCT00397345
Title: TroVax Renal Immunotherapy Survival Trial Study Summary: The purpose of this study is to investigate whether TroVax, when added to first line standard of care therapy, improves survival for patients with locally advanced or metastatic clear cell renal adenocarcinoma. Sponsor: Oxford BioMedica Intervention: Trovax Start Date: 2006-09 Last Updated: 2020-10-19 Number of Patients: 733 Recruitment Status: COMPLETED Condition: Clear Cell Renal Carcinoma
NCTID: NCT00548704
Title: A Clinical Trial on Topotect® (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracyclines Study Summary: The purpose of this study is * To prevent progression of a lesion caused by anthracycline extravasation into necrosis, which would require surgical intervention * To prevent development of deep tissue necrosis and destruction leading to impaired limb function and neurological deficit * To prevent postponement of the scheduled cancer treatment due to the treatment of the extravasation Sponsor: Onxeo Intervention: Dexrazoxane Start Date: 2002-04 Last Updated: 2015-10-21 Number of Patients: 57 Recruitment Status: COMPLETED Condition: Extravasation
NCTID: NCT02188927
Title: Effect of an Advanced Notification Letter on Screening Colonoscopy Participation Study Summary: Participation in a primary screening colonoscopy programs remains low. Advanced notification letter has been shown to increase participation in colorectal cancer screening with fecal occult blood testing and to be cost effective compared to standard invitation. It is unknown whether advanced notification letter increases participation rate in primary colonoscopy screening program. We hypothesize that an Advance Notification Letter will have significant influence on participation in screening colonoscopy, comparing to standard invitation procedure and will thus result in higher efficiency of the program. This randomized controlled study aims to compare the participation rate in screening colonoscopy in response to advanced notification plus standard invitation letter and standard invitation letter alone. Material and methods: 6800 individuals aged 55-64 years will be drawn from the Population Registry and randomly assigned in a 1:1 ratio to the group invited for screening colonoscopy with advanced notification letter (send two weeks before standard invitation) plus standard invitation (send six weeks before planned screening colonoscopy) or to standard invitation only (send six weeks before planned screening colonoscopy). The sample size was calculated to detect 3% difference in participation rate between the groups (25% vs 28%) with 80% power. Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: Implementation of ANL Start Date: 2014-08 Last Updated: 2014-07-14 Number of Patients: 6800 Recruitment Status: UNKNOWN Condition: Colorectal Cancer
NCTID: NCT00006249
Title: Interferon Alfa Following Surgery in Treating Patients With Stage III Melanoma Study Summary: RATIONALE: Interferon alfa may interfere with the growth of the cancer cells. It is not yet known if this treatment is more effective than observation following surgery for stage III melanoma. PURPOSE: Randomized phase III trial to determine the effectiveness of interferon alfa in treating patients who have undergone surgery for stage III melanoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: pegylated interferon alfa Start Date: 2000-06 Last Updated: 2015-02-10 Number of Patients: 1258 Recruitment Status: UNKNOWN Condition: Melanoma (Skin)
NCTID: NCT01818752
Title: Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma Study Summary: The primary objective was to compare the progression-free survival of transplant ineligible patients newly diagnosed with multiple myeloma who were treated with carfilzomib, melphalan and prednisone (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP). Sponsor: Amgen Intervention: Carfilzomib Start Date: 2013-07-08 Last Updated: 2019-08-26 Number of Patients: 955 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT01524926
Title: CREATE: Cross-tumoral Phase 2 With Crizotinib Study Summary: The study will primarily assess the antitumor activity of crizotinib in a variety of tumors with alterations in ALK and/or MET pathways. The targeted patient population will include patients with tumors harboring specific alterations leading to ALK and/or MET activation, where tyrosine kinase inhibitors against these targets have not yet been adequately explored. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Crizotinib (PF-02341066) Start Date: 2012-09 Last Updated: 2023-02-15 Number of Patients: 582 Recruitment Status: COMPLETED Condition: Locally Advanced and/or Metastatic Anaplastic Large Cell Lymphoma
NCTID: NCT04994093
Title: Creating an Innovative AI-based Technology TCRact for Designing and Optimizing T-cell Receptors (TCR) for Use in Cancer Immunotherapies Study Summary: The PROJECT OBJECTIVE is to create an innovative AI-based (Artificial Intelligence) IN SILICO TECHNOLOGY for the design and optimization of T-cell receptors (TCRs) capable of recognizing specific tumor antigens presented on Human Leukocyte Antigen (HLA). The technology will be based on bioinformatics (including molecular modelling) and artificial intelligence (including predictive, generative and optimization models). PROJECT TASKS are dedicated to the implementation of individual technological components (including the database necessary for their preparation) and to performing IN VITRO evaluation rounds to optimize the technology. Integration, within an IN SILICO TECHNOLOGY, of processes which currently require huge amounts of in vitro laboratory experiments that are necessary for bringing new TCR-based cancer immunotherapies into clinical trials: * finding appropriate TCRs targeting cancer neoantigen presented on a HLA molecule (pHLA) * testing for potential TCR toxicity (targeting self antigens presented on healthy tissues) * optimization of pHLA:TCR binding affinity and toxicity. Sponsor: Ardigen Intervention: Collection of blood (PBMC), biopsy (FFPE) and stool samples. Start Date: 2021-10-06 Last Updated: 2022-01-14 Number of Patients: 100 Recruitment Status: RECRUITING Condition: Colon Cancer
NCTID: NCT06128863
Title: Pembrolizumab in Combination With Eftilagimod Alpha and Radiotherapy in Neoadjuvant Treatment of Patients With Soft Tissue Sarcoma - EFTISARC-NEO Trial Study Summary: This is a phase II single-arm single-stage study evaluating efficacy and safety of pembrolizumab in combination with a soluble LAG-3 protein, eftilagimod alpha (Efti) and radiotherapy in neoadjuvant treatment of patients with soft tissue sarcomas. This study will determine the pathologic response rate (defined as percentage of tumor hyalinization/fibrosis) to the combination treatment. Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: Pembrolizumab, Eftilagimod alpha Start Date: 2023-07-17 Last Updated: 2023-11-13 Number of Patients: 40 Recruitment Status: RECRUITING Condition: Neoadjuvant
NCTID: NCT00002763
Title: High-Dose or Low-Dose Interferon Alfa Compared With No Further Therapy Following Surgery in Treating Patients With Stage III Melanoma Study Summary: RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not known whether giving high-dose or low-dose interferon alfa is more effective than no further therapy in treating patients with stage III melanoma. PURPOSE: Randomized phase III trial to compare the effectiveness of high- or low-dose interferon alfa with that of no further therapy following surgery in treating patients who have stage III melanoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: recombinant interferon alfa Start Date: 1996-04 Last Updated: 2011-11-16 Number of Patients: 1000 Recruitment Status: UNKNOWN Condition: Melanoma (Skin)
NCTID: NCT05132582
Title: A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer Study Summary: This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in. All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer. Sponsor: Seagen Inc. Intervention: Tucatinib Start Date: 2022-03-07 Last Updated: 2023-11-21 Number of Patients: 650 Recruitment Status: RECRUITING Condition: HER2 Positive Breast Cancer
NCTID: NCT03673306
Title: Safety of Pregnancy in BRCA Mutated Breast Cancer Patients Study Summary: The present study aims at refining the understanding of the effect of pregnancy on breast cancer outcomes in the specific population of BRCA mutated patients with known history of breast cancer. Sponsor: Jules Bordet Institute Intervention: Clinical outcomes Start Date: 2017-01-16 Last Updated: 2018-09-17 Number of Patients: 2200 Recruitment Status: UNKNOWN Condition: Breast Cancer
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: NCT00005052
Title: Vaccine Therapy in Treating Patients With Primary Stage II Melanoma Study Summary: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether vaccine therapy is more effective than observation alone for melanoma. PURPOSE: This randomized phase III trial is studying vaccine therapy to see how well it works compared to observation alone in treating patients with primary stage II melanoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: GM2-KLH vaccine Start Date: 1999-12 Last Updated: 2009-02-09 Number of Patients: NA Recruitment Status: UNKNOWN Condition: Melanoma (Skin)
NCTID: NCT05518526
Title: Phase 1b/2 Study of Liposomal Annamycin (L-Annamycin) in Subjects With Previously Treated Soft-Tissue Sarcomas (STS) With Pulmonary Metastases Study Summary: This study is a multi-centre, open-label, single-arm, 3+3 Phase 1b/ and Phase II. Phase 1b is aimed to determine the maximum-tolerated dose (MTD)/Recommended Phase 2 Dose (RP2D) based on safety reporting. The RP2D is a multifactorial endpoint that considers toxicity as well as additional determinants (e.g. efficacy, pharmacodynamics) to define the optimal Phase 2 dose. Phase 2 will explore the efficacy of L-Annamycin at RP2D for treating soft tissue sarcomas (STS) subjects with lung metastases, for which chemotherapy is considered appropriate. Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: Liposomal Annamycin (L-Annamycin) Start Date: 2022-08-23 Last Updated: 2022-08-26 Number of Patients: 64 Recruitment Status: RECRUITING Condition: Soft Tissue Sarcoma
NCTID: NCT01788982
Title: Nintedanib(BIBF1120) in Thyroid Cancer Study Summary: For the treatment of thyroid cancer with the so called targeted therapy the angiogenesis pathway has several potential targets. The Receptors for Vascular endothelial growth factor (VEGF) and especially VEGFR-2 is considered to be crucial for the initiation of the formation as well as the maintenance of tumor vasculature. In thyroid cancer these VEGF receptors (VEGFR-1, VEGFR-2), VEGF itself and receptors of the fibroblast growth factor (FGF) and for the platelet-derived growth factor (PDGF) are often overexpressed. Other cells as pericytes and smooth muscle cells that are also involved in tumor angiogenesis express these receptors as well. Inhibitors of the VEGFR or PDGFR pathway have been tested in thyroid cancer with positive results. However there is no treatment that is generally considered as standard of care for patients with differentiated thyroid cancer (DTC) or medullar thyroid cancer (MTC) who have progressed on one line of therapy. The classical cytotoxic chemotherapy has not shown a clinically meaningful benefit yet. Nintedanib is a triple angiogenesis inhibitor which inhibits receptors of VEGF, FGF and PDGF. Therefore it might act not only on endothelial cells but also on pericytes and smooth muscle cells. Nintedanib also interacts with other kinases such as RET. Because of this multi-kinase activity rationale exists to investigate the effect in MTC and DTC. Because it targets these three major angiogenesis signaling pathways it might prevent further tumor growth and related tumor escape mechanisms. Therefore nintedanib may be active in patients who have progressed on agents that target only one pathway. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Nintedanib Start Date: 2014-05 Last Updated: 2020-07-31 Number of Patients: 100 Recruitment Status: COMPLETED Condition: Medullary Thyroid Cancer (MTC)
NCTID: NCT01080391
Title: Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma Study Summary: The primary objective was to compare progression-free survival in adults with relapsed multiple myeloma who are receiving CRd vs participants receiving Rd in a randomized multicenter setting. Sponsor: Amgen Intervention: Dexamethasone Start Date: 2010-07-14 Last Updated: 2022-09-21 Number of Patients: 792 Recruitment Status: COMPLETED Condition: Relapsed Multiple Myeloma
NCTID: NCT02340208
Title: A Phase I/II Open-Label, Non-Randomized Dose Escalation Study of Immunoconjugate L-DOS47 Study Summary: The primary purpose of this research study is to evaluate how safe, how well tolerated and how effective a range of doses of L-DOS47 in patients with non-squamous non-small cell lung cancer when given as a monotherapy. Sponsor: Helix BioPharma Corporation Intervention: L-DOS47 Start Date: 2012-05 Last Updated: 2019-03-14 Number of Patients: 76 Recruitment Status: COMPLETED Condition: Non-Small Cell Lung Cancer
NCTID: NCT04729608
Title: Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer Study Summary: This is a randomized, double-blind Phase 3 study to compare the efficacy and safety of batiraxcept (AVB-S6-500) in combination with paclitaxel (PAC) versus placebo in combination with PAC in patients with platinum resistant recurrent ovarian cancer. Sponsor: Aravive, Inc. Intervention: Batiraxcept Start Date: 2021-04-22 Last Updated: 2023-10-30 Number of Patients: 366 Recruitment Status: TERMINATED Condition: Platinum-resistant Ovarian Cancer
NCTID: NCT00004179
Title: Combination Chemotherapy With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin’s Lymphoma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether chemotherapy is more effective with or without rituximab for relapsed non-Hodgkin’s lymphoma. PURPOSE: This randomized phase III trial is studying combination chemotherapy and rituximab to see how well they work compared to combination chemotherapy alone in treating patients with relapsed non-Hodgkin’s lymphoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: rituximab Start Date: 1999-05 Last Updated: 2021-02-15 Number of Patients: 475 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT00022191
Title: Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract 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 combination chemotherapy regimen is more effective for urinary tract cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus gemcitabine with or without paclitaxel in treating patients who have stage IV urinary tract cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: cisplatin Start Date: 2001-05 Last Updated: 2013-06-12 Number of Patients: 608 Recruitment Status: COMPLETED Condition: Bladder Cancer
NCTID: NCT02332408
Title: CyberKnife Based Hypofractionated Radiotherapy for Vertebral Hemangiomas Study Summary: Clinical objective of the study is to compare the analgesic effect, toxicity and pathologic effect in the tumors of two radiotherapy schedules used for patients suffering from painful vertebral haemangiomas Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: Cybernetic microradiosurgery Start Date: 2014-09 Last Updated: 2015-01-06 Number of Patients: 80 Recruitment Status: UNKNOWN Condition: Hemangioma of Vertebral Column
NCTID: NCT00066391
Title: Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer Study Summary: RATIONALE: Drugs used in chemotherapy such as irinotecan and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Combining irinotecan with cisplatin may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining irinotecan with cisplatin in treating patients who have locally advanced or metastatic penile cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: cisplatin Start Date: 2003-06 Last Updated: 2012-09-24 Number of Patients: NA Recruitment Status: COMPLETED Condition: Penile Cancer
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: NCT03651375
Title: Hypofractionated Radiotherapy With Sequential Chemotherapy in Marginally Resectable Soft Tissue Sarcomas of Extremities or Trunk Wall Study Summary: After a screening, which consists of biopsy, physical examination, initial diffusion-weighted magnetic resonance imaging (DWI-MRI), body computed tomography (CT) scan, blood tests and case analysis on Multidisciplinary Team (MDT) meeting, a patient will receive the first course of chemotherapy - doxorubicin 75 mg/sqm and ifosfamide 10 g/sqm (AI regimen) with prophylactic mesna. Then a patient will be irradiated 5x5 Gy and after radiotherapy he or she will receive two courses of AI within 4-6 weeks, depending on the tolerance. Then the response analysis in DWI-MRI and toxicity assessment and will be performed. On the second MDT meeting, a final decision about resectability of the tumor will be made. In case of resectability, a patient will be referred to surgery. Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: Sequential chemotherapy - 3 courses of AI Start Date: 2017-02-11 Last Updated: 2021-01-22 Number of Patients: 46 Recruitment Status: UNKNOWN Condition: Sarcoma
NCTID: NCT00209209
Title: Induction Chemotherapy (R-CHOP Vs. R-FC) Followed by Interferon Maintenance Versus Rituximab Maintenance in MCL Study Summary: The aim of this study is to answer the following independent questions in the treatment of mantle cell lymphomas: * Can rituximab-fludarabine, cyclophosphamide (R-FC) improve the reduction of lymphoma mass compared to rituximab-cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) and so become a new standard for initial cytoreductive therapy? * Can maintenance with rituximab substitute the interferon maintenance and even improve the progression free survival in patients after successful initial cytoreductive therapy? Sponsor: European Mantle Cell Lymphoma Network Intervention: Rituximab Start Date: 2004-01-14 Last Updated: 2017-03-07 Number of Patients: 570 Recruitment Status: UNKNOWN Condition: Lymphoma, Mantle-Cell
NCTID: NCT00028704
Title: Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy Study Summary: RATIONALE: Breast-conserving treatments such as radiation therapy or limited surgery are less invasive than mastectomy and may improve the quality of life. It is not yet known if breast-conserving treatments are as effective as mastectomy followed by radiation therapy in treating locally advanced breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of breast-conserving therapy with mastectomy followed by radiation therapy in treating women who have locally advanced breast cancer that has been previously treated with chemotherapy. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: conventional surgery Start Date: 2001-10 Last Updated: 2012-07-18 Number of Patients: 26 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT05563467
Title: Pembrolizumab in the Treatment of Advanced, Progressive Adrenocortical Carcinoma. Study Summary: This study is a national, multicenter, interventional, phase II clinical trial on the use of pembrolizumab in advanced adrenocortical carcinoma, with confirmed progression within 6 months, following EDP or EDP-M ( etoposide, doxorubicin, cisplatin- mitotan) chemotherapy. Adrenocortical carcinoma is a very rare entity with poor prognosis and limited therapeutic options. Only radical surgical treatment of the early stages gives a chance for complete cure, however the risk of recurrence still remains high. The results of clinical trials conducted outside Poland indicate a possible potential role of immunotherapy as a rescue treatment for adrenocortical carcinoma after standard therapeutic methods have been exhausted. This study will evaluate the efficacy and tolerability of treatment with the immune checkpoint inhibitor pembrolizumab in locally advanced, non-operable or metastatic adrenocortical carcinoma after first line chemotherapy failure. The study population will include adult patients (>18 years of age) with histopathologically confirmed adrenocortical carcinoma and confirmed progression according to RECIST 1.1 within 6 months, after first line chemotherapy with the EDP and EDP-M scheme. Patients must meet the inclusion criteria and must not meet the exclusion criteria described in the PEMBR-01 study protocol. The planned number of patients in the study is 24. The treatment regimen will be based on Pembrolizumab administered intravenously in 3 weeks cycles at a dose of 200mg. For hormonally active tumors producing cortisol, it is hypothesized that the use of pembrolizumab in combination with effective steroidogenesis inhibition may enhance the effect of immunotherapy. In the study, metyrapone or ketoconazole will be used for this purpose. The primary endpoint of the study will be the objective response rate to the treatment. The secondary endpoints will be progression-free survival, duration of response, overall survival, and treatment safety as well as the effect of therapy on patients’ quality of life. Concurrently, the analysis of biomarkers in tumor tissue will be carried out, including tumour infiltrating lymphocytes, expression of programmed death ligand, microsatellite instability and tumour mutation burden. Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: Pembrolizumab 25 MG/ML [Keytruda] Start Date: 2023-01-31 Last Updated: 2023-03-07 Number of Patients: 24 Recruitment Status: RECRUITING Condition: Adrenocortical Carcinoma
NCTID: NCT01183156
Title: Re-invitation to Screening Colonoscopy: a Randomized Study Study Summary: The aim of this study is to compare the effect of reminding letter and educational intervention on attendance to screening colonoscopy in nonresponders to initial invitation to screening colonoscopy. Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: Re-invitation letter Start Date: 2010-08 Last Updated: 2011-02-16 Number of Patients: 1000 Recruitment Status: UNKNOWN Condition: Colorectal Cancer
NCTID: NCT03353753
Title: Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies Study Summary: This is a 2-arm, randomized, placebo-controlled, double-blind, international, multicenter study comparing the efficacy of ripretinib (DCC-2618) to placebo in patients who have received treatment with prior anticancer therapies. Prior anticancer therapies must include imatinib, sunitinib, and regorafenib (3 prior therapies). Approximately 120 patients were randomized in a 2:1 ratio to ripretinib 150 mg QD or placebo Sponsor: Deciphera Pharmaceuticals LLC Intervention: DCC-2618 Start Date: 2018-02-27 Last Updated: 2022-11-21 Number of Patients: 129 Recruitment Status: COMPLETED Condition: Gastrointestinal Stromal Tumors
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: NCT03583710
Title: Mitotane With or Without Cisplatin and Etoposide After Surgery in Treating Patients With Stage I-III Adrenocortical Cancer With High Risk of Recurrence Study Summary: This phase III trial studies how well mitotane alone works compared to mitotane with cisplatin and etoposide when given after surgery in treating patients with adrenocortical cancer that has a high risk of coming back (recurrence). Cortisol can cause the growth of adrenocortical tumor cells. Antihormone therapy, such as mitotane, may lessen the amount of cortisol made by the body. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether mitotane alone or mitotane with cisplatin and etoposide after surgery works better in treating patients with adrenocortical carcinoma. Sponsor: M.D. Anderson Cancer Center Intervention: Cisplatin Start Date: 2018-08-20 Last Updated: 2023-09-26 Number of Patients: 240 Recruitment Status: RECRUITING Condition: ENSAT Stage I Adrenal Cortex Carcinoma
NCTID: NCT02361346
Title: Safety, PD & Efficacy of MT-3724 for the Treatment of Patients With Relapsed or Refractory DLBCL Study Summary: The purpose of this study is to evaluate the safety and tolerability of MT-3724 in subjects with relapsed or refractory B-Cell NHL or relapsed and refractory CLL (Part 1 only) and relapsed and refractory DLBCL (Part 2 and Part 3). Part 3 evaluates the efficacy of MT-3724. Sponsor: Molecular Templates, Inc. Intervention: MT-3724 Phase 1 Start Date: 2015-02 Last Updated: 2022-08-18 Number of Patients: 38 Recruitment Status: TERMINATED Condition: Non-Hodgkin’s B-cell Lymphoma
NCTID: NCT01665014
Title: Total Marrow Irradiation and High-dose Melphalan for Double Autologous Hematopoietic Stem Cell Transplantation in Multiple Myeloma Study Summary: The purpose of this study is to evaluate if the use total marrow irradiation (TMI) as a sole preparation for the first autologous hematopoietic stem cell transplantation (autoHSCT) followed by high-dose melphalan used prior to second autoHSCT is safe and effective in patients with multiple myeloma (MM). Sponsor: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Intervention: Total marrow irradiation Start Date: 2012-08 Last Updated: 2012-08-17 Number of Patients: 50 Recruitment Status: UNKNOWN Condition: Multiple Myeloma
NCTID: NCT04442022
Title: A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma Study Summary: The purpose of this Phase 2/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor (40 milligram <math display="block">mg</math> or 60 mg) in combination with R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response. Phase 3 portion of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response. Sponsor: Karyopharm Therapeutics Inc Intervention: Selinexor (combination therapy) Start Date: 2020-09-03 Last Updated: 2023-10-03 Number of Patients: 501 Recruitment Status: RECRUITING Condition: Relapsed/Refractory Diffuse Large B-cell Lymphoma
NCTID: NCT00209222
Title: Efficacy of R-CHOP vs R-CHOP/R-DHAP in Untreated MCL Study Summary: The aim of this study is to determine whether alternating courses of cyclophosphamide, doxorubicin, vincristine, prednisone/dexamethasone, cytarabine, cisplatin (CHOP/DHAP) plus rituximab followed by total body irradiation <math display="block">TBI</math>/high dose cytarabine <math display="block">ARA-C</math>/melphalan-peripheral blood stem cell transplantation (TAM-PBSCT) can improve the time to treatment failure compared to CHOP plus rituximab followed by standard PBSCT (dexamethasone, carmustine, cytarabine, etoposide, and melphalan <math display="block">Dexa-BEAM</math>/TBI/high dose cyclophosphamide) in patients with untreated mantle cell lymphoma. Sponsor: European Mantle Cell Lymphoma Network Intervention: Rituximab Start Date: 2004-07 Last Updated: 2012-09-10 Number of Patients: 360 Recruitment Status: UNKNOWN Condition: Lymphoma, Mantle-Cell
NCTID: NCT02808247
Title: Ph II Nintedanib vs. Ifosfamide in Soft Tissue Sarcoma Study Summary: This is a prospective, multicentric, randomized, open label Phase II trial investigating whether the oral angiogenesis inhibitor nintedanib, as compared to the intravenous cytotoxic compound ifosfamide, given for patients with advanced, inoperable and/or metastatic STS after failure of first line chemotherapy prolongs progression-free survival. The primary objective of the trial is to evaluate whether nintedanib given as second-line therapy for advanced, inoperable and/or metastatic STS prolongs progression-free survival when compared with ifosfamide. Secondary objectives are to evaluate the efficacy of nintedanib as compared to ifosfamide in terms of progression-free survival rate at 12 weeks, overall survival, objective response rate, patient benefit rate, response duration, total duration of treatment with nintedanib safety, Health related Quality of Life and Health Economics. Exploratory objectives include an analysis of putative predictive biomarkers for the anti-tumor effects of the investigational agent nintedanib.treatment. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Nintedanib Start Date: 2017-07-07 Last Updated: 2021-09-20 Number of Patients: 80 Recruitment Status: TERMINATED Condition: Sarcoma, Soft Tissue
NCTID: NCT02631447
Title: Sequential Combo Immuno and Target Therapy (SECOMBIT) Study Study Summary: To evaluate the best sequencing approach with the combination of target agents (LGX818 plus MEK162) and the combination of immunomodulatory antibodies (ipilimumab plus nivolumab) in patients with metastatic melanoma and BRAF V600 mutation. Sponsor: Fondazione Melanoma Onlus Intervention: LGX818 Start Date: 2016-11-14 Last Updated: 2023-09-13 Number of Patients: 251 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Melanoma
NCTID: NCT01189253
Title: Doxorubicin Hydrochloride or Trabectedin in Treating Patients With Previously Untreated Advanced or Metastatic Soft Tissue Sarcoma Study Summary: RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride and trabectedin, 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 trabectedin is more effective than doxorubicin hydrochloride in treating patients with advanced or metastatic soft tissue sarcoma. PURPOSE: This randomized phase II/III trial is studying the safety of trabectedin compared with doxorubicin hydrochloride and to see how well they work in treating patients with advanced or metastatic soft tissue sarcoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: doxorubicin hydrochloride Start Date: 2011-05 Last Updated: 2014-08-08 Number of Patients: 133 Recruitment Status: TERMINATED Condition: Sarcoma
NCTID: NCT01839994
Title: Conformal Radiotherapy (CRT) Alone Versus CRT Combined With HDR BT or Stereotactic Body Radiotherapy for Prostate Cancer Study Summary: The purpose of this study is to compare the outcomes of conventionally fractionated conformal radiotherapy with CF-CRT combined with either high-dose-rate brachytherapy or stereotactic body radiotherapy for intermediate or high-risk prostate cancer patients. Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: CF-CRT combined with BT or SBRT boost. Start Date: 2013-06 Last Updated: 2013-04-25 Number of Patients: 350 Recruitment Status: UNKNOWN Condition: Prostate Cancer
NCTID: NCT04031677
Title: Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma Study Summary: This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival. After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Surgery Start Date: 2021-01-20 Last Updated: 2023-10-27 Number of Patients: 250 Recruitment Status: RECRUITING Condition: Retroperitoneal Sarcoma
NCTID: NCT04921553
Title: Real Word European Registry of NTRK Fusions and Other Rare Actionable Fusions (TRacKING) Study Summary: This registry will make it possible to describe real life management of patients with rare actionable fusions and to better understand these cancers. In addition of clinical data from the medical files, a quality of life questionnaire (QLQ-C30) will be complete at inclusion, at each new treatment and then every 6 months. The patients will be followed for a period of at least 2 years after the inclusion. This TRacKING registry is a European collaborative tool to improve the management of patients with actionable fusions, by sharing of data from rare tumor indications. Sponsor: Centre Leon Berard Intervention: Data collection and quality of life questionnaire Start Date: 2021-06-22 Last Updated: 2021-08-02 Number of Patients: 500 Recruitment Status: RECRUITING Condition: Cancer
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: NCT01502696
Title: Adjuvant PEG Intron in Ulcerated Melanoma Study Summary: Patients with an ulcerated melanoma with Breslow >1 mm, N0M0 have a significantly higher risk for relapse than patients with a non-ulcerated primary and about a 40-50% chance of developing stage IV disease to which they will almost invariably succumb. In stage I and II patients with an ulcerated primary who have been sentinel node (SN-staged) and found to be SN-negative there is still a 25-30% relapse risk. The purpose of this study is to evaluate the effectiveness and safety when treated with PEG IFN alfa-2b for 2 years as compared to observation (no treatment), administered after adequate surgery has been performed for ulcerated primary cutaneous melanomas. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: PEG IFN alfa-2b Start Date: 2012-10 Last Updated: 2019-03-04 Number of Patients: 1200 Recruitment Status: UNKNOWN Condition: Ulcerated Melanomas
NCTID: NCT04337931
Title: A Study to Evaluate Sotigalimab (APX005M) in Subjects With Unresectable or Metastatic Melanoma Study Summary: This is a multicenter, open label, Phase 2 study, with 3 parallel cohorts. The aim of the study is to evaluate the efficacy of APX005M administered at 2 different schedules to adult subjects with unresectable or metastatic melanoma. Subjects who have not received prior immunotherapy will be alternately assigned to 1 of 2 cohorts (2 different APX005M administration schedules) as long as both are open. Subjects who have failed approved immunotherapy regimens will be assigned to a 3rd cohort of APX005M in combination with radiation therapy. Sponsor: Apexigen America, Inc. Intervention: APX005M Start Date: 2019-12-16 Last Updated: 2023-09-01 Number of Patients: 44 Recruitment Status: COMPLETED Condition: Unresectable Melanoma
NCTID: NCT05465031
Title: Sacubitril/Valsartan in PriMAry preventIoN of the Cardiotoxicity of Systematic breaST canceR trEAtMent (MAINSTREAM) Study Summary: Breast cancer is the most commonly cancer in women in the overall global population. According to the World Cancer Research Fund International, there were more than 2.25 million new cases of breast cancer in women in 2020. Although the modern treatment strategies, based on the complex care, which consists of surgery, radiotherapy, hormone therapy, and targeted chemotherapy directed at specific cancer molecules have substantially reduced the risk of death due to breast cancer, their wide adoption results in the wider prevalence of cardiotoxicity, defined as either symptomatic heart failure, or asymptomatic contractile dysfunction. The occurrence of cardiotoxicity induced by anti-cancer therapies is estimated at 5-15%, and its development is the primary cause of therapy termination, which significantly reduces the probability of the efficacy of treatment. Several attempts have been made to determine the efficacious preventive strategy, which could diminish the risk of cancer-therapy induced cardiotoxicity. The results of the prior studies indicated a trend towards lower risk of troponin elevation, or left ventricular contractile dysfunction with the introduction of drugs interfering with the renin-angiotensin-aldosterone (RAA) axis, which constitute the primary treatment modality in heart failure with reduced ejection fraction (HFrEF). Sacubitril/valsartan, the novel therapeutic agent, has been demonstrated to significantly improve prognosis in patients with HFrEF. Prior retrospective, small, single-center studies have shown that treatment with sacubitril/valsartan may reduce the risk of cancer-therapy induced cardiotoxicity, or reverse contractile dysfunction caused by anti-cancer therapy. However, no large randomized data confirmed these findings. Therefore, the Sacubitril/Valsartan in PriMAry preventIoN of the cardiotoxicity of systematic breaST canceR trEAtMent) study, has been designed to verify, whether the preventive use of sacubitril/valsartan administered in the doses recommended in patients with HFrEF in breast cancer patients undergoing adjuvant chemotherapy with anthracyclines or anthracyclines and HER-2 monoclonal antibodies, will reduce the incidence of cardiotoxicity defined as impaired left ventricular systolic function on cardiac magnetic resonance imaging (MRI). In the trial, a total of 480 patients with histologically confirmed breast cancer, who are eligible for chemotherapy with anthracyclines or anthracyclines and HER-2 monoclonal antibodies, will undergo 1:1 randomization to either preventive treatment with sacubitril/valsartan or placebo. The patients will be followed for 24 months, and will have repetitive efficacy and safety examinations, including echocardiography, MRI, electrocardiography including 24-h Holter monitoring, blood tests, functional capacity tests and quality of life assessment. Sponsor: Silesian Centre for Heart Diseases Intervention: Sacubitril-valsartan Start Date: 2023-02 Last Updated: 2022-07-19 Number of Patients: 600 Recruitment Status: NOT_YET_RECRUITING Condition: Breast Cancer
NCTID: NCT05117242
Title: Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer Study Summary: The purpose of this trial is to investigate the safety and efficacy of acasunlimab (also known as GEN1046) as monotherapy and in combination with pembrolizumab in patients with non-small cell lung cancer who have progressed during or after treatment of previous standard of care Sponsor: Genmab Intervention: Acasunlimab Start Date: 2021-10-27 Last Updated: 2023-11-18 Number of Patients: 160 Recruitment Status: RECRUITING Condition: Non Small Cell Lung Cancer Metastatic
NCTID: NCT00003888
Title: Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective for advanced head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy plus radiation therapy in treating patients who have advanced head and neck cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: cisplatin Start Date: 1999-04 Last Updated: 2018-07-09 Number of Patients: 359 Recruitment Status: COMPLETED Condition: Head and Neck Cancer
NCTID: NCT00005589
Title: Combination Chemotherapy Plus Peripheral Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin’s Lymphoma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combination chemotherapy plus peripheral stem cell transplantation is more effective with or without rituximab for non-Hodgkin’s lymphoma. PURPOSE: This randomized phase III trial is studying giving combination chemotherapy and peripheral stem cell transplantation together with rituximab to see how well it works compared to combination chemotherapy and peripheral stem cell transplantation alone in treating patients with relapsed non-Hodgkin’s lymphoma. Sponsor: EBMT Solid Tumors Working Party Intervention: filgrastim Start Date: 1999-10 Last Updated: 2013-09-17 Number of Patients: 460 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT01505972
Title: Time Schedules for Sending Invitations to Colonoscopy Screening Study Summary: The attendance rate to population based primary screening colonoscopy within NordICC trial (The Nordic-European Initiative on Colorectal Cancer, NCT00883792) in Poland is roughly 33%. The aim of this study is to compare the effect of two different time schedules for sending invitations and reminding letters to a pre-specified colonoscopy appointment. 1,600 screening naive men and women 55 to 64 years of age are randomly assigned in a 1:1 ratio to receive invitation and reminder 6 and 3 weeks (SIX and THREE group) or 4 and 2 weeks (FOUR and TWO group) prior to pre-specified screening colonoscopy appointment date. Outcome measures are participation in screening colonoscopy within 6 months from the date of invitation, response and acceptance rate before sending a reminder. The study is powered to detect 7% difference in participation in screening colonoscopy. Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: Six and three time schedule Start Date: 2011-03 Last Updated: 2012-01-10 Number of Patients: 1600 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT05352672
Title: Clinical Study of Fianlimab in Combination With Cemiplimab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma Study Summary: The primary objective of the study is to demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by progression-free survival (PFS) The secondary objectives of the study are: * To demonstrate superiority of fianlimab (REGN3767) + cemiplimab compared to pembrolizumab, as measured by overall survival (OS) * To demonstrate superiority in objective response rate (ORR) with fianlimab + cemiplimab compared to pembrolizumab * To characterize ORR, PFS, and OS with fianlimab + cemiplimab compared to cemiplimab to inform the contribution of each component * To assess immunogenicity of fianlimab and cemiplimab * To assess impact of fianlimab + cemiplimab on physical functioning and role functioning and global health status/quality of life, as compared to pembrolizumab in adults * To characterize safety and tolerability of treatment in patients 12 to <18 years of age * To characterize ORR, PFS, and OS with treatment in patients 12 to <18 years of age * To assess the safety and tolerability of fianlimab + cemiplimab compared to pembrolizumab and to cemiplimab * To characterize pharmacokinetics (PK) of fianlimab and cemiplimab using sparse PK sampling in patients aged ≥12 years Sponsor: Regeneron Pharmaceuticals Intervention: Fianlimab Start Date: 2022-07-14 Last Updated: 2023-11-24 Number of Patients: 1590 Recruitment Status: RECRUITING Condition: Melanoma
NCTID: NCT02093962
Title: Study of TH-302 or Placebo in Combination With Pemetrexed in Patients With Non-squamous Non-small Cell Lung Cancer Study Summary: The purpose of this study is to determine whether TH-302 in combination with pemetrexed is safe and effective in the treatment of non-squamous non-small cell lung cancer. Sponsor: Threshold Pharmaceuticals Intervention: TH-302 combination with pemetrexed Start Date: 2014-06 Last Updated: 2021-03-25 Number of Patients: 265 Recruitment Status: TERMINATED Condition: Non-small Cell Lung Cancer
NCTID: NCT02194842
Title: Phase III Radium 223 mCRPC-PEACE III Study Summary: The primary objective of the trial is to assess if upfront combination of enzalutamide and Ra223 improves radiological progression-free survival (rPFS1) compared to enzalutamide single agent in CRPC patients metastatic to bone Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Ra223 Start Date: 2015-10 Last Updated: 2023-03-30 Number of Patients: 446 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostate Cancer
NCTID: NCT00005062
Title: Radiation Therapy in Patients With Limited-Stage Small Cell Lung Cancer in Complete Remission Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and prevent the spread of cancer to the brain. It is not yet known if standard-dose radiation therapy is more effective than high-dose radiation therapy in preventing the spread of limited-stage small cell lung cancer cells to the brain. PURPOSE: This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with limited-stage small cell lung cancer in complete remission. Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Intervention: radiation therapy Start Date: 1999-09 Last Updated: 2014-03-13 Number of Patients: NA Recruitment Status: COMPLETED Condition: Lung Cancer
NCTID: NCT05992610
Title: Induction Treatment in SCC of the Head and Neck Region - Concomitant Chemotherapy and Low-dose Radiotherapy Study Summary: Non-commercial clinical study to assess: # efficacy of iCHRTL in patients with advanced squamous cell carcinoma of oral cavity, pharynx carcinoma, larynx carcinoma or paranasal sinus carcinoma. # tolerability of iCHRTL in patients with advanced squamous cell carcinoma of oral cavity, pharynx carcinoma, larynx carcinoma or paranasal sinus carcinoma. # molecular and biochemical effect of low doses of ionizing radiation. Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: Chemotherapy (carboplatin+paclitaxel) with concomitant low dose ionizing radiotherapy Start Date: 2022-02-17 Last Updated: 2023-08-15 Number of Patients: 40 Recruitment Status: RECRUITING Condition: Squamous Cell Carcinoma of Oral Cavity
NCTID: NCT03639610
Title: PK of Melphalan During Treatment With Melflufen and Dexamethasone in Patients With RRMM and Impaired Renal Function Study Summary: This was a multicenter study of the pharmacokinetics (PK) of melphalan during treatment with melflufen and dexamethasone in patients with relapsed refractory multiple myeloma (RRMM) and impaired renal function. Sponsor: Oncopeptides AB Intervention: Melflufen Start Date: 2018-08-28 Last Updated: 2023-03-10 Number of Patients: 35 Recruitment Status: TERMINATED Condition: Renal Impairment
NCTID: NCT04681131
Title: CAB-AXL-ADC Safety and Efficacy Study in Adults With NSCLC Study Summary: The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in NSCLC Sponsor: BioAtla, Inc. Intervention: CAB-AXL-ADC Start Date: 2021-03-17 Last Updated: 2023-09-25 Number of Patients: 240 Recruitment Status: RECRUITING Condition: Non-Small-Cell Lung Cancer
NCTID: NCT03238066
Title: Salvage Brachytherapy and Interstitial Hyperthermia for Locally Recurrent Prostate Carcinoma Following Radiation Therapy Study Summary: Salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent prostate carcinoma following external beam radiation therapy. Sponsor: University of Erlangen-Nürnberg Medical School Intervention: Brachytherapy Start Date: 2015-04 Last Updated: 2018-06-07 Number of Patients: 77 Recruitment Status: UNKNOWN Condition: Prostate Cancer
NCTID: NCT01098266
Title: NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed Study Summary: The main objective of the trial is to document the efficacy of NGR-hTNF administered at low dose weekly in advanced Malignant Pleural Mesothelioma patients previously treated with a pemetrexed-based chemotherapy regimen. Sponsor: AGC Biologics S.p.A. Intervention: NGR-hTNF plus Best Investigator’s Choice (BIC) Start Date: 2010-04-12 Last Updated: 2019-09-17 Number of Patients: 400 Recruitment Status: COMPLETED Condition: Malignant Pleural Mesothelioma
NCTID: NCT01908621
Title: Randomized Trial of G-CSF Alone Versus Intermediate-dose Ara-C Plus G-CSF Mobilization in Multiple Myeloma Patients. Study Summary: The purpose of the study is to compare safety and efficacy of stem cell mobilization using G-CSF (filgrastim) alone vs. intermediate-dose cytosine arabinoside plus G-CSF in multiple myeloma patients. Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: G-CSF (filgrastim) Start Date: 2013-03-20 Last Updated: 2018-08-28 Number of Patients: 90 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT01125566
Title: LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment Study Summary: To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment Sponsor: Boehringer Ingelheim Intervention: BIBW 2992 Start Date: 2010-06-22 Last Updated: 2019-07-18 Number of Patients: 508 Recruitment Status: COMPLETED Condition: Breast Neoplasms
NCTID: NCT05501886
Title: Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1) Study Summary: This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy. Sponsor: Celcuity, Inc. Intervention: Gedatolisib Start Date: 2022-09-30 Last Updated: 2023-08-01 Number of Patients: 701 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT03562637
Title: Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC Study Summary: The GLORIA study is a Phase III, randomized, open-label study to prospectively evaluate the efficacy and safety of adagloxad simolenin (OBI 822)/OBI-821 in the adjuvant treatment of patients with high risk, early stage Globo-H Positive TNBC. Sponsor: OBI Pharma, Inc Intervention: adagloxad simolenin combined with OBI-821 Start Date: 2018-12-05 Last Updated: 2023-08-16 Number of Patients: 668 Recruitment Status: RECRUITING Condition: Triple Negative Breast Cancer
NCTID: NCT00937183
Title: Dendritic Cell Vaccine in Treating Patients With Indolent B-Cell Lymphoma or Multiple Myeloma Study Summary: RATIONALE: Biological therapies, such as a dendritic cell vaccine made with a patient’s cancer cells, may stimulate the immune system in different ways and stop cancer cells from growing. PURPOSE: This phase I/II trial is studying the side effects of dendritic cell vaccine and to see how well it works in treating patients with indolent B-cell lymphoma or multiple myeloma. Sponsor: Jan Walewski Intervention: autologous lymphoma cell lysate-pulsed autologous dendritic cell vaccine Start Date: 2003-09 Last Updated: 2019-08-19 Number of Patients: 12 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT05730192
Title: EAGLE Trial CADDIE Artificial Intelligence Endoscopy Study Summary: The EAGLE study is a prospective randomized controlled multicenter parallel design trial, for the assessment of clinical performance of the CADDIE device and to confirm that the device performs as expected. Sponsor: Odin Medical Intervention: CADDIE Start Date: 2023-05-10 Last Updated: 2023-09-28 Number of Patients: 950 Recruitment Status: RECRUITING Condition: Colorectal Cancer
NCTID: NCT00883792
Title: The Northern-European Initiative on Colorectal Cancer Study Summary: Colorectal cancer (CRC) is a major burden in western countries. The disease develops from precursor lesions during a long time-interval. Colonoscopy can detect and remove CRC precursor lesions and may thus be effective for CRC prevention. Many national and international health organisations demand evidence from randomised trials to reduce incidence or mortality of the target disease before advocating population-wide cancer screening. However, while colonoscopy screening for the prevention of colorectal cancer is established in the United States and several European countries, no randomised trials exist to quantify the possible benefit of colonoscopy screening. NordICC is a randomised trial investigating the effect of colonoscopy on CRC incidence and mortality. NordICC is a multicentre, randomised trial in Nordic countries, the Netherlands and Poland. A minimum of 66 000 individuals, age 55-64 years, are drawn randomly from the population registries in the participating countries. 22 000 are invited for once-only colonoscopy (2:1 randomisation). Expected work-load with 50% compliance will be 11,000 colonoscopies. At the screening examination, all detected lesions are biopsied and removed whenever possible. The remaining 44 000 individuals (control group) are not offered any screening examination (care as usual).The primary study aims are CRC incidence and CRC mortality after 15 years of follow-up, with an interim analysis after 10 years of follow-up. In an intention-to-treat approach, a risk reduction of CRC mortality of 25% in the colonoscopy screening group compared to the control group is expected after 10 years follow-up, estimating 50% compliance in the screening group. Sponsor: Oslo University Hospital Intervention: Colonoscopy Start Date: 2009-05 Last Updated: 2017-06-19 Number of Patients: 95000 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Colorectal Cancer
NCTID: NCT05109442
Title: Study to Assess AFM24 in Combination With Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers Study Summary: AFM24-102 is a Phase 1/2a open-label, non-randomized, multicenter, dose escalation, and expansion study evaluating AFM24 in combination with atezolizumab in patients with selected EGRF-expressing advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies. Sponsor: Affimed GmbH Intervention: AFM24 Start Date: 2021-11-19 Last Updated: 2023-08-29 Number of Patients: 148 Recruitment Status: RECRUITING Condition: Advanced Solid Tumor
NCTID: NCT02929394
Title: Trabectedin Maintenance Post 1st-line in STS Study Summary: Maintenance therapy with trabectedin versus observation after first line treatment with doxorubicin of patients with advanced or metastatic soft tissue sarcoma. This is a prospective, multicenter, randomized, open label Phase III trial investigating whether a maintenance treatment with trabectedin, as compared to the observational approach, can prolong progression-free survival in patients with advanced, inoperable and/or metastatic STS after response or stabilisation during first line treatment with doxorubicin. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Trabectedin Start Date: 2017-11-07 Last Updated: 2020-09-02 Number of Patients: 13 Recruitment Status: TERMINATED Condition: Sarcoma, Soft Tissue
NCTID: NCT02834884
Title: SPECTA: Screening Cancer Patients for Efficient Clinical Trial Access Study Summary: SPECTA is a quality assured platform for collecting clinicopathologically annotated biological material, imaging data, operative images, environmental assessment, questionnaires as well as patient-reported outcomes from cancer patients to support biospecimen-based translational research and clinical cancer research, including biomarker discovery to improve the understanding of tumor biology and cancer patients care. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: RP-1828 IMMUcan Start Date: 2017-05-03 Last Updated: 2023-11-03 Number of Patients: 4975 Recruitment Status: RECRUITING Condition: All Tumor Types
NCTID: NCT00003941
Title: Combination Chemotherapy With or Without Peripheral Stem Cell Transplant in Treating Men With Previously Untreated Germ Cell Cancer 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. Peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy and kill more cancer cells. It is not yet known whether chemotherapy and peripheral stem cell transplant is more effective than chemotherapy alone. PURPOSE: This randomized phase III trial is studying how well combination chemotherapy works when given with peripheral stem cell transplant and how it compares with combination chemotherapy alone in treating men with previously untreated germ cell cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: bleomycin sulfate Start Date: 1999-04 Last Updated: 2012-09-24 Number of Patients: 222 Recruitment Status: COMPLETED Condition: Mediastinal Cancer
NCTID: NCT01344018
Title: Surgery With or Without Radiation Therapy in Untreated Nonmetastatic Retroperitoneal Sarcoma Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy 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 surgery is more effective with or without radiation therapy in treating nonmetastatic retroperitoneal soft tissue sarcoma. PURPOSE: This randomized phase III trial is studying radiation therapy followed by surgery to see how well it works compared with surgery alone in treating patients with previously untreated nonmetastatic retroperitoneal soft tissue sarcoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: therapeutic conventional surgery Start Date: 2012-01 Last Updated: 2023-04-24 Number of Patients: 266 Recruitment Status: COMPLETED Condition: Sarcoma
NCTID: NCT00002462
Title: RT or No RT Following Chemotherapy in Treating Patients With Stage III/IV Hodgkin’s Disease Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with combination chemotherapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with no radiation therapy following chemotherapy in treating patients with stage III or stage IV Hodgkin’s disease. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: bleomycin sulfate Start Date: 1989-09 Last Updated: 2023-02-15 Number of Patients: 615 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lymphoma
NCTID: NCT03669718
Title: A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC Study Summary: This will be a blinded, placebo-controlled, randomized, phase 2 study in which subjects will be randomly assigned 1:1 to cemiplimab plus placebo or cemiplimab plus ISA101b. Sponsor: ISA Pharmaceuticals Intervention: ISA101b Start Date: 2018-11-30 Last Updated: 2023-04-12 Number of Patients: 194 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Squamous Cell Carcinoma of the Oropharynx
NCTID: NCT00003034
Title: ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen Study Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether Onconase plus doxorubicin is more effective than doxorubicin alone in treating patients with malignant mesothelioma. PURPOSE: This randomized phase III trial is studying doxorubicin alone to see how well it works compared to doxorubicin and Onconase in treating patients with malignant mesothelioma. Sponsor: Alfacell Intervention: doxorubicin hydrochloride Start Date: 1997-05 Last Updated: 2013-11-06 Number of Patients: 300 Recruitment Status: UNKNOWN Condition: Malignant Mesothelioma
NCTID: NCT03677141
Title: A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma Study Summary: This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (M-CHOP) and, subsequently, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) plus polatuzumab vedotin (CHP-pola) in participants with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), and in previously untreated participants with diffuse large B-cell lymphoma (DLBCL). Sponsor: Hoffmann-La Roche Intervention: Mosunetuzumab Start Date: 2019-03-08 Last Updated: 2023-11-09 Number of Patients: 117 Recruitment Status: COMPLETED Condition: B-cell Non-Hodgkin Lymphoma
NCTID: NCT00025636
Title: Combination Chemotherapy and Peripheral Stem Cell Transplant in Treating Patients With Relapsed 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. Peripheral stem cell transplant may allow the doctors to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which combination chemotherapy regimen given before peripheral stem cell transplant is more effective in treating relapsed Hodgkin’s lymphoma. PURPOSE: This randomized phase III trial is comparing different regimens of combination chemotherapy followed by peripheral stem cell transplant to see how well they work in treating patients with relapsed Hodgkin’s lymphoma. Sponsor: German Hodgkin’s Lymphoma Study Group Intervention: filgrastim Start Date: 2001-07 Last Updated: 2013-09-17 Number of Patients: 220 Recruitment Status: UNKNOWN Condition: Lymphoma
NCTID: NCT02435602
Title: The Role of Chromoendoscopy in the Early Detection of Esophageal Cancer in Patients With Prior Head and Neck Cancers Study Summary: This study evaluates the role of narrow band imaging (NBI) endoscopy compared with Lugol chromoendoscopy in the early detection of esophageal cancer in patients with prior head and neck cancers. Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: NBI endoscopy Start Date: 2013-12 Last Updated: 2018-04-13 Number of Patients: 294 Recruitment Status: COMPLETED Condition: Esophageal Squamous Cell Carcinoma
NCTID: NCT02054923
Title: The Effect of Routine Video-recording on Colonoscopy Quality Indicators. Study Summary: Routine video recording of the colonoscopy examination has been proposed as a simple and easy to implement method that could improve the quality of colonoscopy. The purpose of this study is to investigate whether implementation of routine video recording of screening colonoscopy withdrawal is effective as a means of supporting quality performance of colonoscopy. The study will be performed in 8 screening centers within the framework of a national colonoscopy screening program in Poland (the Polish Colonoscopy Screening Platform; PCSP). Individuals aged 55-64 years are eligible to participate in the PCSP. In the run-in period colonoscopy quality measures will be monitored through a dedicated joint database. Then eligible screening centres will be randomly assigned in a 1:1 ratio to the video recording group or the control group. Screening centres assigned to the video recording group will receive videorecorders and DVDs and will be asked to video record all screening colonoscopies (only withdrawal). Control group will be allowed to record colonoscopies on demand only. Then , the colonoscopy quality measures will again be monitored through a dedicated joint database. All the recorded DVDs will be reviewed to verify ceacal intubation and withdrawal time by the PCSP team. Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: Implementation of routine videorecording Start Date: 2014-03 Last Updated: 2015-08-05 Number of Patients: 5200 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT04348058
Title: Telephone Services for Participation in Colorectal Cancer Screening Study Summary: A multicentre randomized health services study within the population-based primary colonoscopy screening program (PCSP) in Poland. Individuals, aged 55-60 years, willl be randomized in a 1:1:1 ratio to arms: (1) Invitation by post, (2) Call Center or (2) Combined invitation methods. The primary outcome measure is rate of participation in screening colonoscopy. The sample size of 6 300 participants will detect 3 to 5 percentage point differences (depending on the arms comparison) in participation rate between groups with 80% power and significance level 0.05, using Ochran-Mantel-Haenszel test. Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: Telephone recruitment to screening colonoscopy Start Date: 2020-08-20 Last Updated: 2020-04-15 Number of Patients: 6300 Recruitment Status: UNKNOWN Condition: Participation Rate, Patient
NCTID: NCT00004884
Title: Docetaxel and Gemcitabine Compared With Docetaxel and Cisplatin in Treating Patients With Metastatic or Locally Advanced Pancreatic 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 may kill more tumor cells. It is not yet known whether docetaxel plus gemcitabine is more effective than docetaxel plus cisplatin in treating advanced pancreatic cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of docetaxel and gemcitabine with that of docetaxel and cisplatin in treating patients who have metastatic or locally advanced pancreatic cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: cisplatin Start Date: 1999-07 Last Updated: 2012-09-24 Number of Patients: 96 Recruitment Status: COMPLETED Condition: Pancreatic Cancer
NCTID: NCT00030680
Title: Radiation Therapy in Treating Patients With Aggressive Fibromatoses Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients who have aggressive fibromatoses. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: radiation therapy Start Date: 2001-11 Last Updated: 2013-08-27 Number of Patients: 44 Recruitment Status: COMPLETED Condition: Desmoid Tumor
NCTID: NCT00110123
Title: Intravenous or Hepatic Arterial Infusion of Fotemustine in Treating Patients With Unresectable Liver Metastases From Eye Melanoma Study Summary: RATIONALE: Drugs used in chemotherapy, such as fotemustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving the drugs in different ways may kill more tumor cells. It is not yet known whether giving fotemustine as an intravenous infusion is more effective than giving it as a hepatic arterial infusion in treating liver metastases. PURPOSE: This randomized phase III trial is studying intravenous infusion of fotemustine to see how well it works compared to hepatic arterial infusion of fotemustine in treating patients with unresectable liver metastases from eye melanoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: fotemustine Start Date: 2005-01 Last Updated: 2012-09-24 Number of Patients: 171 Recruitment Status: TERMINATED Condition: Intraocular Melanoma
NCTID: NCT00005584
Title: Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With 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. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin’s lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy with or without radiation therapy in treating patients who have Hodgkin’s lymphoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: bleomycin sulfate Start Date: 1998-10 Last Updated: 2023-02-15 Number of Patients: 1649 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lymphoma
NCTID: NCT01665001
Title: Personalized Therapy of Precursor Lymphoid Neoplasms Study Summary: The primary goal of this study by The Polish Adult Leukemia Group (PALG) is to verify if individual therapeutic approach taking into account biological and phenotypic differences as well as response at the level of minimal residual disease is associated with improved outcome of adults with precursor lymphoid neoplasms Sponsor: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Intervention: Treatment strategy: induction, consolidation, HSCT, maintenance Start Date: 2012-08 Last Updated: 2012-08-17 Number of Patients: 200 Recruitment Status: UNKNOWN Condition: Precursor Lymphoid Neoplasms
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: NCT03989596
Title: Hypofractionated Radiotherapy With Hyperthermia in Unresectable or Marginally Resectable Soft Tissue Sarcomas Study Summary: After a screening, which consists of biopsy, physical examination, initial diffusion-weighted magnetic resonance imaging (DWI-MRI) or body computed tomography (CT) scan, blood tests and case analysis on Multidisciplinary Team (MDT) meeting, a patient will receive the hypofractionated radiotherapy 10x 3.25 Gy with regional hyperthermia (twice a week) within two weeks. The response analysis in CT or DWI-MRI and toxicity assessment will be performed after at least 6 weeks. At the second MDT meeting, a final decision about resectability of the tumor will be made. In case of resectability or consent for amputation, if required, a patient will be referred to surgery. In case of unresectability or amputation refusal, the patient will receive the second part of the treatment which consists of 4x 4 Gy with hyperthermia (twice a week). Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: Hypofractionated radiotherapy Start Date: 2018-06-01 Last Updated: 2021-02-01 Number of Patients: 30 Recruitment Status: UNKNOWN Condition: Sarcoma
NCTID: NCT01667198
Title: Randomized Study of Train the Colonoscopy Leaders Course Versus Audit and Feedback on Colonoscopy Quality Indicators Study Summary: Professional societies recommend that endoscopists measure their ceacal intubation rate, adenoma detection rate as indicators of the screening colonoscopy quality. However, it is uncertain how to improve adenoma detection rate and reduce inter-endoscopists’ variability in the detection of adenomas. The investigators hypothesize that a hands-on-training intervention tailored to the results of environmental assessment and audit on colonoscopy quality indicators results in higher adenoma detection rate improvement than simple audit and feedback. The investigators further hypothesize that by training the leaders of the screening centres, the effect of the intervention will be further disseminated among other endoscopists from the participating centers, and will thus result in additional increase in individual adenoma detection rate. The primary aim is to compare the impact on adenoma detection rate of two screening colonoscopy improvement programs: # Tailored training intervention. # Audit feedback on colonoscopy quality indicators. Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: Train the leaders course Start Date: 2012-07 Last Updated: 2014-04-16 Number of Patients: 40 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT01082198
Title: Melanoma Vaccine in Treating Patients With Stage III Melanoma After Surgery to Remove Lymph Nodes Study Summary: RATIONALE: Vaccines made from dendritic cells and tumor antigen peptides or a person’s tumor cells may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best way to give melanoma vaccine in treating patients with stage III melanoma after surgery to remove the lymph nodes. Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: HLA-A1-binding MAGE-1/MAGE-3 multipeptide-pulsed autologous dendritic cell vaccine Start Date: 2002-10 Last Updated: 2013-08-26 Number of Patients: 22 Recruitment Status: UNKNOWN Condition: Melanoma (Skin)
NCTID: NCT03917381
Title: GEN1046 Safety Trial in Patients With Malignant Solid Tumors Study Summary: The purpose of the trial is to evaluate the safety of acasunlimab (also known as GEN1046) as monotherapy and in combination therapies in patients with malignant solid tumors Sponsor: Genmab Intervention: Acasunlimab Start Date: 2019-05-14 Last Updated: 2023-11-18 Number of Patients: 752 Recruitment Status: RECRUITING Condition: Solid Tumors
NCTID: NCT03449381
Title: This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors) Study Summary: This study is open to adults with different types of advanced cancer (solid tumors). The purpose of this study is to find out the most suitable dose of BI 907828 (brigimadlin) the participants can tolerate. The most suitable dose is used in the second part to find out whether brigimadlin makes tumors shrink. In this study, brigimadlin is given to humans for the first time. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer. Brigimadlin is taken as a tablet. Participants either take a dose of brigimadlin on one day every 3 weeks or on two days every 4 weeks. The participants are in the study for as long as they benefit from and can tolerate treatment. The doctors regularly check the participants’ general health during the study. Sponsor: Boehringer Ingelheim Intervention: BI 907828 Start Date: 2018-05-21 Last Updated: 2023-11-15 Number of Patients: 269 Recruitment Status: RECRUITING Condition: Neoplasms
NCTID: NCT00014274
Title: Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium 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 may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective for transitional cell cancer of the urothelium. PURPOSE: Randomized phase II/III trial to compare different combination chemotherapy regimens in treating patients who have transitional cell cancer of the urothelium. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: carboplatin Start Date: 2001-01 Last Updated: 2013-06-12 Number of Patients: 238 Recruitment Status: COMPLETED Condition: Bladder Cancer
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: NCT04136470
Title: BioForte Technology for in Silico Identification of Candidates for a New Microbiome-based Therapeutics and Diagnostics Study Summary: The goal of the project is to develop and validate the BioForte technology. Its main functionality should be to in silico determine candidates for novel microbiome-based therapeutics and diagnostics. Key challenge to be solved using the technology is to detect the differences in gut microbiome between oncology patients who respond to immunotherapies and the ones who do not respond to this treatment. This technology employs machine learning methods to replace the laboratory procedure for finding valuable genomic features. Such features can be crucial to identify differences between the two populations (e.g. responders vs non-responders) to target specific strains. The samples and data collected in this clinical study will be used for clinical validation of BioForte technology. For all patients treated with immunotherapy, stool collection will be performed per patient (one stool collection before setting up immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies). Samples will be sequenced by long-read sequencing technology. In parallel, we will also collect samples of peripheral blood samples (PBMC) and biopsy (FFPE). Sponsor: Ardigen Intervention: Collection of stool, blood (PBMC) and biopsy (FFPE) Start Date: 2019-04-01 Last Updated: 2020-08-10 Number of Patients: 130 Recruitment Status: UNKNOWN Condition: Non Small Cell Lung Cancer
NCTID: NCT04398095
Title: Radiotherapy With Hyperthermia in Recurrent and Radiation-Induced Sarcomas Study Summary: After a screening, which consists of biopsy, physical examination, initial diffusion-weighted magnetic resonance imaging (DWI-MRI) or body computed tomography (CT) scan, blood tests and case analysis on Multidisciplinary Team (MDT) meeting, a patient with radiation-induced or in-field recurrent sarcoma will receive the hypofractionated radiotherapy with deep hyperthermia (twice a week) within three weeks. The response analysis in CT or DWI-MRI and toxicity assessment will be performed after 6 weeks. In resectable tumors, a patient will be referred to surgery. In the case of unresectability, the patient will followed-up. Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: Hypofractionated radiotherapy Start Date: 2019-10-23 Last Updated: 2021-04-28 Number of Patients: 20 Recruitment Status: UNKNOWN Condition: Radiation Induced Neoplasms
NCTID: NCT05840211
Title: Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy Study Summary: The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to current available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician’s choice (TPC) on progression-free survival (PFS). Sponsor: Gilead Sciences Intervention: Sacituzumab Govitecan-hziy Start Date: 2023-05-08 Last Updated: 2023-11-18 Number of Patients: 654 Recruitment Status: RECRUITING Condition: Locally Advanced or Unresectable Metastatic Breast Cancer
NCTID: NCT04104776
Title: A Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas Study Summary: First-in-human, open-label, sequential dose escalation and expansion study of CPI-0209 in patients with advanced solid tumors and lymphomas. CPI-0209 is a small molecule inhibitor of EZH2. Sponsor: Constellation Pharmaceuticals Intervention: CPI-0209 Start Date: 2019-09-18 Last Updated: 2023-11-02 Number of Patients: 286 Recruitment Status: RECRUITING Condition: Advanced Solid Tumor
NCTID: NCT02129699
Title: Survival imProvement in Lung cancEr iNduced by DenOsUmab theRapy Study Summary: The purpose of this study is to investigate how well the standard treatment (platinum-based doublet chemotherapy) in combination with denosumab works compared with the standard treatment alone in patients with a type of lung cancer called “non small cell lung cancer” (NSCLC) that has spread to other parts of the body. Sponsor: ETOP IBCSG Partners Foundation Intervention: Denosumab Start Date: 2015-01-06 Last Updated: 2020-08-11 Number of Patients: 514 Recruitment Status: COMPLETED Condition: Lung Cancer Non-small Cell Stage IV
NCTID: NCT00085228
Title: Docetaxel With or Without Oblimersen in Treating Patients With Hormone-Refractory Adenocarcinoma (Cancer) of the Prostate Study Summary: RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of docetaxel by making tumor cells more sensitive to the drug. PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with oblimersen works compared to docetaxel alone in treating patients with hormone-refractory adenocarcinoma (cancer) of the prostate. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: oblimersen sodium Start Date: 2004-04 Last Updated: 2012-09-24 Number of Patients: 116 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT01723969
Title: Screening Platform for Clinical Trials in Advanced Colorectal Cancer Study Summary: The EORTC GastroIntestinal Tract Cancer Group and the EORTC HeadQuarters wish to set up a European screening platform for advanced colo-rectal cancer (CRC) patients. The goal of this screening platform is to provide quick access to new drugs to patients by offering a new structure for clinical trials. Currently some of the most challenging clinical questions arise from the molecular sub-division of CRC that would theoretically allow to inhibit the specific, altered pathways in the patients. A major problem for trials in this “personalized medicine” is that the low frequency of the different mutations requires a high effort for screening and identifying the patients. The EORTC CRC screening platform will hopefully offer a feasible and efficient way to characterize the patients on the molecular basis of their tumors and allow to offer them rapid and preferential participation in clinical studies with new drugs targeted to their specific pathway alterations. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Tumour markers testing Start Date: 2013-09 Last Updated: 2022-07-07 Number of Patients: 668 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT00003013
Title: Chemotherapy Plus Surgery in Treating Women With Breast 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 which treatment regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy plus surgery in treating women who have breast cancer. Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Intervention: CMF regimen Start Date: 1996-10 Last Updated: 2013-09-17 Number of Patients: 450 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT01814969
Title: Preoperative Hyperfractionated Radiotherapy or Radiochemotherapy in Locally Advanced Rectal Cancer. Study Summary: Clinical objective of the study is to compare the rates of pathologic response, acute toxicity and sphincter preservation with two schedules of preoperative regiment in patients with locally advanced rectal cancer. Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: Hyperfractionated Radiochemotherapy Start Date: 2014-03 Last Updated: 2015-05-05 Number of Patients: 260 Recruitment Status: UNKNOWN Condition: Rectal Cancer
NCTID: NCT04711135
Title: Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs Study Summary: This is a multicenter, open-label, single-arm study to evaluate the safety and dosimetry of Lutathera in adolescent patients 12 to <18 years old with somatostatin receptor positive GEP-NETs and PPGLs. The study will enroll at least 8 patients in the GEP-NET cohort and as many adolescents with PPGL as possible in the exploratory PPGL cohort. Sponsor: Advanced Accelerator Applications Intervention: Lutetium [177Lu] oxodotreotide/dotatate Start Date: 2022-08-31 Last Updated: 2023-06-08 Number of Patients: 8 Recruitment Status: RECRUITING Condition: Gastroenteropancreatic Neuroendocrine Tumors
NCTID: NCT04111835
Title: HPV Testing In Polish POpulation-based Cervical Cancer Screening Program. Study Summary: The HIPPO PROJECT is a randomized healthcare study nested in the OCCSP in Poland. This project will assess the performance of the new screening test (HR HPV test) before its implementation in Poland. Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology Intervention: Offering an alternative cervical cancer screening method - hrHPV molecular testing. Start Date: 2019-10-28 Last Updated: 2023-11-18 Number of Patients: 33000 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Cervical Cancer
