Trials (Rijnstate)
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NCTID: NCT00091156
Title: Gefitinib After Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Study Summary: RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether giving gefitinib after initial chemotherapy is effective in delaying the recurrence of non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying gefitinib to see how well it works compared to placebo in delaying tumor recurrence in patients who have undergone initial chemotherapy for stage IIIB or stage IV non-small cell lung cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: gefitinib Start Date: 2004-05 Last Updated: 2012-07-16 Number of Patients: 598 Recruitment Status: TERMINATED Condition: Lung Cancer
NCTID: NCT00036556
Title: Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer Study Summary: This study is being done to evaluate the safety and efficacy of atrasentan in men with non-metastatic hormone-refractory prostate cancer. Sponsor: Abbott Intervention: Atrasentan Start Date: 2001-06 Last Updated: 2007-08-15 Number of Patients: 941 Recruitment Status: COMPLETED Condition: Prostatic Neoplasms
NCTID: NCT02931890
Title: Multicentric Randomised Trial for Resectable Gastric Cancer Study Summary: The CRITICS-II trial aims to identify the optimal preoperative regimen in resectable gastric cancer by comparing three investigational treatment arms: chemotherapy vs. chemotherapy and subsequent chemoradiotherapy vs. chemoradiotherapy. The rationale behind this trial design is based on the following concepts: * Preoperative treatment is associated with better patient compliance than postoperative regimens * Preoperative treatment increases the likelihood of disease downsizing/downstaging and radical R0 resections * Preoperative paclitaxel/carboplatin-based concurrent chemoradiotherapy and DOC chemotherapy are effective, feasible and safe regimens Sponsor: The Netherlands Cancer Institute Intervention: Docetaxel Start Date: 2017-12-21 Last Updated: 2022-10-27 Number of Patients: 207 Recruitment Status: RECRUITING Condition: Gastric Cancer
NCTID: NCT03223597
Title: Registry of Treatment Outcomes of Symptomatic Metastasized Castration Resistant Prostate Cancer Treated With Radium-223 Study Summary: Radium-223 is the 5th treatment for metastasized castration resistant prostate cancer with a proven overall survival benefit. The improved survival of Radium-223 over placebo was demonstrated in the ALSYMPCA trial, which included a miscellaneous patient population both docetaxel pretreated and non-pretreated. This registry aims to describe non-study patients treated with Radium-223 and prospectively evaluate treatment outcomes of patients with and without docetaxel pretreatment. Analgesic use and patient reported pain scores, efficacy of the subsequent therapy and overall survival will be evaluated. Moreover, clinical and explorative serum and blood biomarkers of Radium-223 efficacy will be explored. Sponsor: The Netherlands Cancer Institute Intervention: Radium-223 dichloride Start Date: 2015-01-17 Last Updated: 2022-04-15 Number of Patients: 300 Recruitment Status: COMPLETED Condition: Prostate Cancer Metastatic
NCTID: NCT05181059
Title: DLSCT for Breast Cancer Detection in Women With Dense Breasts Study Summary: The main objective of this project is to demonstrate the feasibility of DLSCT to detect breast cancer in women with dense breasts. Patients with locoregional advanced primary breast cancer and heterogeneously (n = 7) or extremely dense breasts (n = 7) as determined by mammography will be included in this study. These patients have an indication for a positron emission tomography computed tomography (PET-CT) scan to search for distant metastases. In this study the participants will undergo an additional contrast enhanced DLSCT scan to determine the feasibility of spectral CT to detect breast cancer in women with dense breasts. Sponsor: Rijnstate Hospital Intervention: Dual-layer spectral computerized tomography (DLSCT) Start Date: 2022-01-01 Last Updated: 2022-01-06 Number of Patients: 14 Recruitment Status: RECRUITING Condition: Breast Neoplasms
NCTID: NCT01523587
Title: LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy Study Summary: This randomised, open-label phase III trial will be performed in patients with advanced squamous cell carcinoma of the lung requiring second-line treatment after receiving first-line platinum-based chemotherapy. The primary objective of this trial is to compare the efficacy of BIBW 2992 to erlotinib as second-line treatment in this group of patients. Sponsor: Boehringer Ingelheim Intervention: afatinib Start Date: 2012-03-05 Last Updated: 2019-02-15 Number of Patients: 795 Recruitment Status: COMPLETED Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT04392037
Title: Iberdomide Combined With Low-dose Cyclophosphamide and Dexamethasone Study Summary: Evaluation of the effect iberdomide combined with low-dose cyclophosphamide and dexamethasone in patients with relapsed/refractory multiple myeloma. Sponsor: Amsterdam UMC, location VUmc Intervention: Iberdomide plus low-dose cyclophosphamide and dexamethasone Start Date: 2021-02-17 Last Updated: 2023-08-16 Number of Patients: 60 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Multiple Myeloma
NCTID: NCT05975437
Title: Effectiveness of Personalized Surveillance and Aftercare for Breast Cancer Study Summary: Surveillance and aftercare for curatively treated primary breast cancer patients is currently mostly ‘one-size-fits-all’, but can be personalized based on patients’ risk of recurrence (depending on patient-, tumor- and treatment-related characteristics) and their personal needs and preferences. The use of personalized surveillance (PSP) and personalized aftercare plans (PAP) based on individual risks and needs might reduce unnecessary burden to the patient, increase quality of life and lower the costs of follow-up. The NABOR study will examine the effectiveness of personalized follow-up care, consisting of personalized surveillance (PSP) and personalized aftercare plans (PAP) incorporating individual recurrence risks and personal needs of breast cancer patients. The main question it aims to answer is: ‘what is the effectiveness of personalized surveillance (PSP) and aftercare plans (PAP), compared to current follow-up care, on cancer worry and self-rated overall quality of life (EQ-VAS)’. Also the effect of PSP and PAP on health-related quality of life (EQ-5D), societal participation, risk perception, patient satisfaction, patients’ need for support, shared decision-making, health care costs and resource use, cost-effectiveness, and number and severity of the detected recurrences will be investigated. Next, the uptake and appreciation of the personalized plans and related factors (patient, caregiver, hospital and societal/financial) will be evaluated. Patients participating in the study will have to fill in several questionnaires and give consent for requesting data from the Netherlands Cancer Registry and from their electronic health records (EHR). The use of personalized surveillance (PSP) and personalized aftercare plans (PAP) will be implemented stepwise over a period of nine months in ten participating hospitals. To collect observations of both pre- and post-transition to PSP and PAP, each hospital will include patients during the nine months before and after its transition to personalized care. In the future, the results of this project, i.e. the developed tools, can also be used for personalization of survivorship care for other cancer survivors. More broadly, all findings will be actively shared with interested healthcare professionals and other interested parties in the Netherlands. Sponsor: Comprehensive Cancer Centre The Netherlands Intervention: personalized surveillance plans (PSP) and personalized aftercare plans (PAP) Start Date: 2023-03-06 Last Updated: 2023-08-03 Number of Patients: 1040 Recruitment Status: ENROLLING_BY_INVITATION Condition: Breast Cancer
NCTID: NCT04646187
Title: De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease Study Summary: BACKGROUND/RATIONALE: Treatment outcomes of patients with inflammatory bowel disease (IBD) have improved enormously during the past decade due to the use of anti-tumour necrosis factor (anti-TNF) therapy. As a result, 67 to 91% of paediatric patients and 66% of adult patients is still in sustained remission two years after the initiation of anti-TNF therapy. Prolonged use of anti-TNFs comes with disadvantages such as dose dependent susceptibility to infections and dermatological adverse effects. Preliminary, mostly uncontrolled studies suggest that dose reduction by dosing interval lengthening is a realistic option in a relevant proportion of patients with IBD, provided that intensive follow-up is applied. OBJECTIVE: To evaluate whether a faecal calprotectin (FC) guided strategy of anti-TNF dosing interval lengthening is non-inferior in maintaining remission in patients with IBD, compared with an unchanged dosing interval. Sponsor: University Medical Center Groningen Intervention: Infliximab Start Date: 2021-03-11 Last Updated: 2022-05-18 Number of Patients: 148 Recruitment Status: RECRUITING Condition: Inflammatory Bowel Diseases
NCTID: NCT00444639
Title: Study to Assess the Non-inferiority of Pamorelin® 11,25mg SC Injected Versus Pamorelin® 11,25mg IM Injected in Patients Suffering From Advanced Prostate Cancer (PAMOJECT) Study Summary: The active ingredient of Pamorelin® 11,25 mg is Triptorelin. Triptorelin is a substitute for a natural hormone produced in the body called Gonadotrophin-releasing hormone (GnRH). GnRH is a hormone secreted by hypothalamus (a gland located in brain) and controls the production of sex hormones (eg testosterone in men) in other organs in the body. The growth of prostate cancer cells, one of the most common cancers in men, is induced by the hormone testosterone. Hormonotherapy is one of treatments available to treat this type of disease by controlling the testosterone serum level. Pamorelin® 11,25 mg is normally injected in the muscle but this type of injection is not suitable for every patient. Therefore the primary purpose of this study is to assess the non-inferiority of the 12-week triptorelin formulation Pamorelin® 11,25 mg administered via subcutaneous (SC) injection as compared to Pamorelin® 11,25 mg administered via standard intramuscular (IM) injection based on the percentage of patients presenting a testosterone level ≤ 50 ng/dl at week 24. Sponsor: Ipsen Intervention: Triptorelin (Decapeptyl®) Start Date: 2007-02 Last Updated: 2019-11-22 Number of Patients: 25 Recruitment Status: TERMINATED Condition: Prostate Cancer
NCTID: NCT05392608
Title: SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast) Study Summary: The study is a nationwide, multicenter single-arm phase 2 study. The current phase 2 study investigates the efficacy of the combination of fulvestrant and alpelisib directly after progression on fulvestrant (either in first or second line, with or without previous use of CDK4/6-inhibitor) in patients with HR+ HER2- advanced breast cancer with PIK3CA mutated tumors. All eligible patients must have progressive disease on fulvestrant as latest treatment line. Previous treatment with a CDK4/6 inhibitor in first or second line is obligatory. After progressive disease is confirmed, it is important to continue fulvestrant (without CDK4/6 inhibition) during the screening period awaiting study enrollment. After study enrollment all participants will be treated with alpelisib and fulvestrant beyond progression. Follow-up time will be until progression or death or until a different oncolytic treatment has started (in case no progressive disease during previous fulvestrant and alpelisib treatment has been documented). Should participants discontinue due to reasons other than progression or death (e.g. toxicity), then they should still be evaluated for disease progression every 8 weeks as per protocol until progression, unless they do not wish to proceed with these screenings, or receive a different oncolytic treatment. Sponsor: Borstkanker Onderzoek Groep Intervention: Alpelisib 150 MG Oral Tablet [Piqray] Start Date: 2022-06-02 Last Updated: 2023-10-06 Number of Patients: 130 Recruitment Status: RECRUITING Condition: Neoplasm, Breast
NCTID: NCT05050942
Title: A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET Study Summary: The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029. Sponsor: Camurus AB Intervention: CAM2029 Start Date: 2021-10-22 Last Updated: 2023-10-06 Number of Patients: 300 Recruitment Status: RECRUITING Condition: Gastro-enteropancreatic Neuroendocrine Tumor
NCTID: NCT03756272
Title: Stellate Ganglion Block to Reduce Hot Flushes Study Summary: To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure Sponsor: Rijnstate Hospital Intervention: Bupivacaine block Start Date: 2017-09-01 Last Updated: 2020-03-11 Number of Patients: 76 Recruitment Status: COMPLETED Condition: Hot Flash
NCTID: NCT02364388
Title: IMAging With Opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO Other Diagnostic Methodologies (MAESTRO) Study Summary: Imagio breast imaging system, is an opto-acoustic (OA) imaging system designed to concurrently collect images in conjunction with diagnostic ultrasound ( co-registered OA and B-mode imaging). This medical device has CE-marking and is approved for use in Europe and other nations. This is a post-market, non-randomized multi-center surveillance study. Sponsor: Seno Medical Instruments Inc. Intervention: Imagio IUS Start Date: 2015-03-27 Last Updated: 2020-04-06 Number of Patients: 217 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT03285763
Title: A Study of Atezolizumab (Tecentriq) to Investigate Long-term Safety and Efficacy in Previously-treated Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Study Summary: This is a Phase III/IV, single-arm, multicenter study of the long-term safety and efficacy of atezolizumab treatment in participants with Stage IIIb or Stage IV NSCLC who have progressed after standard systemic chemotherapy (including if given in combination with anti-programmed cell death protein 1 <math display="block">anti-PD-1</math> therapy, after anti-PD-1 as monotherapy, or after tyrosine kinase inhibitor <math display="block">TKI</math> therapy). The study will consist of a Screening Period, a Treatment Period, a Treatment Discontinuation Visit, and a Follow-Up Period. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2017-10-25 Last Updated: 2022-05-26 Number of Patients: 619 Recruitment Status: COMPLETED Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT02295163
Title: Stellate Ganglion Block for Hot Flushes in Men Treated With ADT Study Summary: Androgen deprivation therapy (ADT) is widely used as standard therapy in the treatment of locally advanced and metastatic prostate cancer. Hot flushes and night sweats are one of the main side-effects of ADT. There are no successful and well-tolerable treatment options available. A possible treatment for hot flushes is stellate-ganglion block (SGB), used as a means of interrupting parts of the sympathetic nervous system involved in temperature regulation. Objective of this study: To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure Sponsor: Rijnstate Hospital Intervention: Stellate ganglion block Start Date: 2014-07 Last Updated: 2021-03-10 Number of Patients: 0 Recruitment Status: WITHDRAWN Condition: Prostate Cancer
NCTID: NCT02112682
Title: Omitting Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy Study Summary: STUDY AIM To decrease the number of breast cancer patients receiving overtreatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life. PRIMARY OBJECTIVE To determine whether omitting completion axillary treatment is not inferior to the current axillary treatment regimen in sentinel node positive breast cancer patients undergoing a mastectomy, in terms of regional recurrence rate. HYPOTHESIS Completion axillary treatment can be safely omitted in sentinel node positive breast cancer patients undergoing a mastectomy. This will lead to a decreased axillary morbidity rate and to an increased quality of life, with non-inferior regional control, distant-disease free- and overall survival rates. Sponsor: Maastricht University Medical Center Intervention: Completion axillary treatment Start Date: 2014-06 Last Updated: 2018-05-09 Number of Patients: 52 Recruitment Status: TERMINATED Condition: Breast Neoplasms
NCTID: NCT03540420
Title: Atezolizumab After Concurrent Chemo-radiotherapy Versus Chemo-radiotherapy Alone in Limited Disease Small-cell Lung Cancer Study Summary: Some patients with limited disease small-cell lung cancer (LD SCLC) are cured after chemo-radiotherapy, but the majority relapse and die from their cancer. Better therapy is needed. Immunotherapy represents the largest advance in cancer therapy in recent years and has demonstrated promising activity in SCLC. In this study we will investigate whether atezolizumab prolongs survival in LD SCLC patients who have undergone chemo-radiotherapy. Sponsor: Norwegian University of Science and Technology Intervention: Atezolizumab Start Date: 2018-07-31 Last Updated: 2023-05-06 Number of Patients: 212 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Small-cell Lung Cancer
NCTID: NCT03820063
Title: Image-guided De-escalation of Neo-adjuvant Chemotherapy in HER2-positive Breast Cancer: the TRAIN-3 Study Study Summary: This is a multicenter, single arm, phase II study evaluating the efficacy of image-guided de-escalating neoadjuvant treatment with paclitaxel, Herceptin® (trastuzumab), carboplatin, and pertuzumab (PTC-Ptz) in stage II-Ill HER2-positive breast cancer. Sponsor: Borstkanker Onderzoek Groep Intervention: PTC-Pz Start Date: 2019-02-27 Last Updated: 2023-02-22 Number of Patients: 462 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT00085163
Title: Celecoxib Combined With Fluorouracil and Leucovorin in Treating Patients With Resected Stage III Adenocarcinoma (Cancer) of the Colon Study Summary: RATIONALE: Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether fluorouracil and leucovorin are more effective with or without celecoxib in treating resected stage III adenocarcinoma (cancer) of the colon. PURPOSE: This randomized phase III trial is studying celecoxib, fluorouracil, and leucovorin to see how well they work compared to fluorouracil and leucovorin in treating patients who have undergone surgery for stage III colon cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: celecoxib Start Date: 2004-03 Last Updated: 2015-10-20 Number of Patients: NA Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT02162563
Title: Treatment Strategies in Colorectal Cancer Patients With Initially Unresectable Liver-only Metastases Study Summary: Colorectal cancer patients with initially unresectable liver-only metastases may be cured after downsizing of metastases by neoadjuvant systemic therapy. However, the optimal neoadjuvant induction regimen has not been defined, and no consensus exist on criteria for resectability. In this study colorectal cancer patients with initially unresectable liver-only metastases, as prospectively confirmed by an expert panel according to predefined criteria, will be tested for RAS and BRAF tumor mutation status and selected by location of primary tumor. Patients with RAS or BRAF mutant and/or right sided tumors will be randomised between doublet chemotherapy (FOLFOX or FOLFIRI) plus bevacizumab (schedule 1), and triple chemotherapy (FOLFOXIRI) plus bevacizumab (schedule 2). Patients with RAS AND BRAF wildtype AND left-sided primary tumors will be randomized between doublet chemotherapy (FOLFOX or FOLFIRI) plus either bevacizumab (schedule 1) or panitumumab (schedule 3). Patient imaging will be reviewed for resectability by a central panel, consisting of at least one radiologist and three surgeons every assessment. Central panel review will be performed prior to randomization as well as during treatment, as described in the protocol. Sponsor: Dutch Colorectal Cancer Group Intervention: FOLFOX/ FOLFIRI with bevacizumab Start Date: 2014-07 Last Updated: 2022-03-25 Number of Patients: 564 Recruitment Status: RECRUITING Condition: Colorectal 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: NCT00988208
Title: Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer Study Summary: The purpose of the study is to determine whether lenalidomide is safe and effective for use in combination with docetaxel and prednisone for the treatment of subjects with metastatic Castrate-Resistant Prostate Cancer. The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life expectancy of these subjects. Sponsor: Celgene Intervention: Lenalidomide Start Date: 2009-11-11 Last Updated: 2018-04-04 Number of Patients: 1059 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT05142904
Title: Radiofrequency Ablation Versus I-131 for Solitary Autonomous Thyroid Nodules Study Summary: The purpose of this study is to compare treatment of hyperthyroidism with radiofrequency ablation or I-131 for solitary autonomous thyroid nodules. Sponsor: Rijnstate Hospital Intervention: Radiofrequency ablation Start Date: 2021-11-17 Last Updated: 2023-04-04 Number of Patients: 232 Recruitment Status: RECRUITING Condition: Thyroid Nodule, Toxic or With Hyperthyroidism
NCTID: NCT01898117
Title: Triple-B Study;Carboplatin-cyclophosphamide Versus Paclitaxel With or Without Atezolizumab as First-line Treatment in Advanced Triple Negative Breast Cancer Study Summary: Triple negative breast cancer (TNBC) is a difficult to treat molecular subtype with a poor survival. TNBC can be divided into at least two molecular entities; BRCA-like and non-BRCA-like. In this trial we would like to investigate whether a molecular subgroup exists within TNBCs that derives a benefit from atezolizumab added to first line chemotherapy. Sponsor: The Netherlands Cancer Institute Intervention: Carbo/cyclo Start Date: 2013-07 Last Updated: 2023-03-23 Number of Patients: 304 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT03228108
Title: Culture-guided Antimicrobial Prophylaxis in Men Undergoing Prostate Biopsy. Study Summary: This study aims to assess the effectiveness and cost-effectiveness of rectal swab culture-guided antimicrobial prophylaxis to reduce infectious complications after transrectal prostate biopsy. Half of participants will receive routine empirical prophylaxis with oral ciprofloxacin (control group), while the other half will receive rectal culture-guided oral antibiotic prophylaxis (intervention group). In the intervention group, men whose rectal swabs do not show ciprofloxacin-resistant bacteria will receive ciprofloxacin prophylaxis, comparable to the control group. In case of ciprofloxacin-resistant bacteria an alternative oral antibiotic based on the culture results will be prescribed (trimethoprim/sulfamethoxazole, fosfomycin or pivmecillinam/augmentin). The investigators hypothesise that the targeted prophylaxis group (intervention group) will have a lower rate of post-biopsy infectious complications compared to the control group. Sponsor: Radboud University Medical Center Intervention: Ciprofloxacin Start Date: 2018-04-03 Last Updated: 2022-05-10 Number of Patients: 1538 Recruitment Status: COMPLETED Condition: Complication
NCTID: NCT03045406
Title: Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer Study Summary: Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study Sponsor: Fadoi Foundation, Italy Intervention: Apixaban Start Date: 2017-04-13 Last Updated: 2019-11-14 Number of Patients: 1168 Recruitment Status: UNKNOWN Condition: Venous Thromboembolism
NCTID: NCT04597671
Title: Durvalumab and Low-dose PCI vs Durvalumab and Observation in Radically Treated Patients With Stage III NSCLC (NVALT28) Study Summary: This trial studies the combination of low-dose PCI with or without durvalumab in patients with radically treated stage III NSCLC. The hypothesis is that the incidence of brain metastases will be reduced from 30% to 15 % with durvalumab and to a maximum of 5% with the addition of low-dose PCI. This strategy would make brain metastases in stage III NSCLC history and this would improve QoL. Sponsor: Association NVALT Studies Intervention: Durvalumab Start Date: 2021-12-06 Last Updated: 2023-06-05 Number of Patients: 170 Recruitment Status: RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT00036543
Title: A Study of Atrasentan in Men With Metastatic, Hormone-Refractory Prostate Cancer Study Summary: This study is being done to evaluate the safety and efficacy of atrasentan in men with metastatic hormone-refractory prostate cancer. Sponsor: Abbott Intervention: Atrasentan Start Date: 2001-05 Last Updated: 2006-08-15 Number of Patients: 1000 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT04995614
Title: Health-related Quality of Life, Psychological Distress and Fatigue in Metastatic CRPC Patients Treated With Radium-223 Study Summary: The aim of the current prospective multicenter study is to evaluate cancer-specific and bone metastases related HR-QoL, psychological distress and fatigue in mCRPC patients before, during and after treatment with radium-223 in daily practice. Furthermore, the investigators aim to determine patient groups with identical health-related quality of life patterns over time, in order to identify variables related to health-related quality of life deterioration during the course of treatment, as patients with health-related quality of life deterioration may need specific attention to preserve health-related quality of life. Sponsor: Radboud University Medical Center Intervention: Radium-223 Start Date: 2017-04-01 Last Updated: 2021-08-09 Number of Patients: 122 Recruitment Status: COMPLETED Condition: Castrate Resistant Prostate Cancer
NCTID: NCT02541383
Title: A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma Study Summary: The purpose of this study is to evaluate if the addition of daratumumab to Bortezomib, Thalidomide and Dexamethasone will increase the stringent complete response rate after consolidation therapy and increase the progression free survival after daratumumab maintenance therapy in transplant eligible participants with previously untreated Multiple Myeloma. Sponsor: Intergroupe Francophone du Myelome Intervention: Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) Start Date: 2015-09 Last Updated: 2020-12-07 Number of Patients: 1085 Recruitment Status: UNKNOWN Condition: Multiple Myeloma
NCTID: NCT03869892
Title: Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy. Study Summary: The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab. Sponsor: Institut de Recherches Internationales Servier Intervention: Trifluridine/tipiracil hydrochloride (S95005) Start Date: 2019-03-21 Last Updated: 2023-11-18 Number of Patients: 856 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Colorectal Cancer
NCTID: NCT02340221
Title: A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy Study Summary: This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm versus the placebo arm. Enrollment will be enriched for participants with PIK3CA mutant tumors via central testing. The anticipated duration of the study is approximately 3.5 years. Sponsor: Hoffmann-La Roche Intervention: Taselisib Start Date: 2015-04-09 Last Updated: 2022-07-12 Number of Patients: 631 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT01566721
Title: A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Study Summary: This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B). Sponsor: Hoffmann-La Roche Intervention: Herceptin Start Date: 2012-05-17 Last Updated: 2021-04-27 Number of Patients: 2577 Recruitment Status: COMPLETED Condition: Breast Neoplasms
NCTID: NCT02950051
Title: Standard Chemoimmunotherapy (FCR/BR) Versus Rituximab + Venetoclax (RVe) Versus Obinutuzumab (GA101) + Venetoclax (GVe) Versus Obinutuzumab + Ibrutinib + Venetoclax (GIVe) in Fit Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without Del(17p) or TP53 Mutation Study Summary: The aim of this study is to evaluate if standard chemoimmunotherapy (FCR, BR) in frontline treatment of physically fit CLL patients without del17p or TP 53 mutation can be replaced by combinations of targeted drugs (Venetoclax, Ibrutinib) with anti-CD20-antibodies (Rituximab, Obinutuzumab), which may induce extremely long lasting remissions. Sponsor: German CLL Study Group Intervention: Fludarabine Start Date: 2016-12-13 Last Updated: 2023-07-06 Number of Patients: 926 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT04470921
Title: STOP OVarian CAncer; Implementation of the Opportunistic Salpingectomy in the Netherlands Study Summary: The aim of this study is to optimize implementation of the opportunistic salpingectomy throughout the Netherlands. Sponsor: Radboud University Medical Center Intervention: Opportunistic Salpingectomy Start Date: 2019-01-01 Last Updated: 2022-11-14 Number of Patients: 10000 Recruitment Status: ENROLLING_BY_INVITATION Condition: Risk Reduction
NCTID: NCT00141466
Title: Implementation of a New Strategy to Identify HNPCC Patients Study Summary: The purpose of this study is to compare two different strategies to implement a new method to identify patients with HNPCC, which appeared cost-effective and feasible. The effectiveness, costs and feasibility of both of the implementation strategies will be assessed. Sponsor: Radboud University Medical Center Intervention: Education for professionals Start Date: 2005-09 Last Updated: 2008-04-23 Number of Patients: 360 Recruitment Status: UNKNOWN Condition: Colorectal Neoplasms
NCTID: NCT03764553
Title: Liposomal iRInotecan, Carboplatin or oXaliplatin for Esophagogastric Cancer Study Summary: This is a multi-center, open label, randomized phase II trial for patients with previously untreated metastatic or locally advanced esophagogastric cancer, using a pick the winner design to identify the best combination therapy in terms of progression free survival and neurotoxicity. Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Intervention: Liposomal Irinotecan Start Date: 2019-05-01 Last Updated: 2022-12-16 Number of Patients: 310 Recruitment Status: RECRUITING Condition: Esophageal Cancer
NCTID: NCT05084729
Title: CONFIDENCE Registry Study Summary: This registry has been designed to obtain real-life, post-market data on the use of the Imagio breast imaging system. This registry is sponsored by Seno Medical Instruments, Inc., the manufacturer of the device. Sponsor: Seno Medical Instruments Inc. Intervention: Imagio OA/US Start Date: 2020-09-11 Last Updated: 2023-10-10 Number of Patients: 165 Recruitment Status: COMPLETED Condition: Breast Abnormality Diagnosis
NCTID: NCT00864253
Title: A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma Study Summary: The main purpose of this research study is to compare the safety, tolerability, and anti tumor activity of an investigational drug, ABI-007 versus Dacarbazine in patients with metastatic melanoma who have not previously received chemotherapy. ABI-007 is a new preparation of the active drug paclitaxel. It contains the same medication as the prescription chemotherapy drug Abraxane®. Abraxane® is approved by the FDA for the treatment of metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Dacarbazine is approved by the FDA for the treatment of melanoma. In this study, ABI-007 and Dacarbazine will be tested as therapy for people who have not yet had any cancer treatment for the diagnosis of metastatic melanoma. Sponsor: Celgene Intervention: ABI-007 Start Date: 2009-04-23 Last Updated: 2019-10-30 Number of Patients: 529 Recruitment Status: COMPLETED Condition: Malignant Melanoma
NCTID: NCT04261829
Title: AFT: Introduction of a Full Breast Reconstructive Method Study Summary: A multicentre prospective cohort study will monitor the efficacy and safety of Autologous Fat Transfer (AFT) with pre-expansion. AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness. It follows the BREAST trial, the randomised controlled trial comparing AFT with implant-based reconstruction. In this study, patients all receive AFT. Sponsor: Maastricht University Medical Center Intervention: Autologous Fat Transfer Start Date: 2020-12-09 Last Updated: 2021-07-29 Number of Patients: 350 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT05180864
Title: Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer Study Summary: Curative therapy for gastric cancer usually consists of perioperative chemotherapy and a radical (R0) gastrectomy. A radical resection includes a modified D2 lymphadenectomy, and, generally, a complete omentectomy, to ensure the removal of omental metastatic lymph nodes and tumor deposits. The omentum has some essential functions within the peritoneal cavity. The omentum functions as regulator of regional immune responses to prevent infections and, additionally, it prevents adhesions that can lead to small bowel obstruction. Omentectomy is associated with increased incidence of early and late postoperative complications such as abdominal abscess, ileus, and wound infections in various types of surgery. There is little evidence regarding survival benefit of routine complete omentectomy during gastrectomy. The investigators hypothesize that omitting a complete omentectomy (and instead preserve the greater omentum distal of the gastroepiploic arcade) during gastrectomy for cancer does not negatively impact survival. OMEGA is a randomized controlled, open, parallel, non-inferiority, multicenter trial. Adult patients (>18 years) with primary resectable gastric cancer, clinical stage T2-4a N0-3 M0 or cT1N+ scheduled for open or minimally invasive (sub)total gastrectomy are included. The primary study objective is to investigate whether omentum preservation in gastrectomy for cancer is non-inferior to complete omentectomy in terms of three-year overall survival. Sponsor: VU University of Amsterdam Intervention: Gastrectomy Start Date: 2024-01-01 Last Updated: 2023-10-30 Number of Patients: 654 Recruitment Status: NOT_YET_RECRUITING Condition: Stomach Neoplasm
NCTID: NCT03184194
Title: Nivolumab Combined With Daratumumab With or Without Low-dose Cyclophosphamide Study Summary: Evaluation of the effect of nivolumab and daratumumab with or without low-dose cyclophosphamide in patients with relapsed/refractory multiple myeloma. Sponsor: Amsterdam UMC, location VUmc Intervention: nivolumab-daratumumab Start Date: 2018-02-21 Last Updated: 2023-05-15 Number of Patients: 62 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Myeloma
NCTID: NCT04232735
Title: Evidence Based Information Provision to Improve Decision Making After Oesophagogastric Cancer Diagnosis (SOURCE) Study Summary: The overarching aim of the programme ‘Stimulating evidence based, personalized and tailored information provision to improve decision making after oesophagogastric cancer diagnosis’ (SOURCE) is to provide oesophagogastric cancer patients at all disease stages with evidence based and personalized information about survival, treatment-related side-effects and/or complications and health related quality of life, tailored to patients’ specific information needs, to facilitate informed decision making about treatment and thereby optimize personal care and outcomes. For this purpose the Source tool and training were designed. The Source tool is a prediction model based website to be used by care givers for informing patients about the outcomes of treatment. The Source training for care givers is designed to learn care givers how to inform patients effectively, especially about the outcomes of treatment. Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Intervention: Tool and training Start Date: 2020-10-13 Last Updated: 2022-12-16 Number of Patients: 126 Recruitment Status: RECRUITING Condition: Oesophageal Cancer
NCTID: NCT04628494
Title: A Phase 3 Trial of Epcoritamab vs Investigator’s Choice Chemotherapy in R/R DLBCL Study Summary: The drug that will be investigated in the study is an antibody, epcoritamab, also known as EPKINLY™ and GEN3013. Since the safety and tolerability of epcoritamab has already been studied in previous studies in humans, the main purpose of this study is to evaluate efficacy. To evaluate this, half of the participants who are eligible will receive epcoritamab and the other half will receive a pre-specified investigator’s choice of chemotherapy. Epcoritamab will be studied in R/R DLBCL participants who did not respond to a previous autologous stem cell transplant (ASCT) or do not meet the criteria for ASCT Sponsor: Genmab Intervention: Epcoritamab Start Date: 2021-01-13 Last Updated: 2023-08-07 Number of Patients: 552 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT02135510
Title: MEtoclopramide, DExamethasone or Axoli to Prevent or Delay Chemotherapy-induced Nausea and Vomiting in Moderately Emetogenic Non-AC-based Chemotherapy Study Summary: In this phase III non-inferiority trial, the aim is to evaluate whether metoclopramide and palonosetron prophylactic antemetic treatment are non-inferior to dexamethasone with regard to its efficacy to prevent delayed chemotherapy-induced nausea and vomiting (CINV) induced by non- anthracyclines plus cyclophosphamide (AC) based moderately emetogenic chemotherapy (MEC). Sponsor: Amsterdam UMC, location VUmc Intervention: metoclopramide Start Date: 2013-06 Last Updated: 2020-03-31 Number of Patients: 249 Recruitment Status: COMPLETED Condition: Solid Tumors
NCTID: NCT02916992
Title: Prevalence of Spontaneous Pneumothorax in BHD Study Summary: To assess the prevalence of BHD (Birt-Hogg-Dubé syndrome) among patients with spontaneous pneumothorax. Patients who were treated for primary spontaneous pneumothorax in Rijnstate hospital are to be included. Patients will receive a questionnaire. When given consent, the investigators will invite them for a one-time visit to the out-patient clinic. Patients will be asked for a blood sample to determine pathogenic FLCN (folliculin) mutations and a pulmonary CT scan for evaluation of presence of lung cysts. Sponsor: Hans Smit Intervention: CT scan of the thorax Start Date: 2016-09 Last Updated: 2016-10-26 Number of Patients: 200 Recruitment Status: UNKNOWN Condition: Spontaneous Pneumothorax
NCTID: NCT00014612
Title: Comparison of Complete Axillary Lymph Node Dissection With Axillary Radiation Therapy in Treating Women With Invasive Breast Cancer Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be a less invasive treatment and cause fewer side effects than complete axillary lymph node dissection. It is not yet known which treatment is more effective for invasive breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of complete axillary lymph node dissection with that of axillary radiation therapy in treating women who have invasive breast cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: axillary lymph node dissection Start Date: 2001-02 Last Updated: 2013-10-29 Number of Patients: 4813 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT04489173
Title: TAS102 in Patients With ER-positive, HER2-negative Advanced Breast Cancer Study Summary: This is a multicenter phase 2 study evaluating the efficacy and safety of trifluridine/tipiracil in women with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy. Sponsor: Borstkanker Onderzoek Groep Intervention: trifluridine/tipiracil Start Date: 2020-09-25 Last Updated: 2023-02-22 Number of Patients: 50 Recruitment Status: RECRUITING Condition: Breast Neoplasm
NCTID: NCT03191110
Title: The COLON Study: Colorectal Cancer Cohort Study Summary: The main aim of this observational, prospective cohort study is to assess associations of diet and other lifestyle factors with colorectal cancer recurrence, survival and quality of life. Sponsor: Wageningen University Intervention: No intervention: observational study Start Date: 2010-08-03 Last Updated: 2018-10-09 Number of Patients: 2000 Recruitment Status: RECRUITING Condition: Colorectal Neoplasms Malignant
NCTID: NCT05671510
Title: ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors Study Summary: The goal of this Phase 3 clinical trial is study the safety and efficacy of the nextgen anti-CTLA-4 antibody, gotistobart (ONC-392/BNT316), in patients with metastatic non-small cell lung cancer who have disease progressed on anti-PD-1/PD-L1 antibody based therapy. The study will test whether gotistobart, in comparison with chemotherapy agent docetaxel, could prolong the life for NSCLC patients. Patients will be randomized to be treated with either gotistobart or docetaxel, IV infusion, once every 21 days, for up to 17 cycles in approximately one year. Sponsor: OncoC4, Inc. Intervention: Gotistobart Start Date: 2023-06-28 Last Updated: 2023-10-12 Number of Patients: 600 Recruitment Status: RECRUITING Condition: Non Small Cell Lung Cancer
NCTID: NCT00135980
Title: Integrated Care for Cancer Patients; Developing, Implementing and Testing a Programme to Improve Integrated Care Study Summary: The purpose of this study is to compose, implement and evaluate a programme to improve the quality of integrated care for patients with cancer. Literature will be searched for components of integrated care programmes. On the basis of evidence based multi-disciplinary guidelines and literature on integrated care programmes, a set of indicators will be composed. This set will be measured in 6 hospitals on patients with non-small-cell-lung cancer. In two hospitals, an integrated care programme will be implemented and effects on processes and outcomes of care will be measured. Sponsor: Radboud University Medical Center Intervention: professional audit and feedback Start Date: 2004-08 Last Updated: 2007-03-01 Number of Patients: 300 Recruitment Status: UNKNOWN Condition: Neoplasms
NCTID: NCT02100696
Title: A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors Study Summary: This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with moderately to severely active ulcerative colitis (UC) who have been previously exposed to TNF inhibitors. Sponsor: Hoffmann-La Roche Intervention: Etrozulimab Start Date: 2014-05-21 Last Updated: 2021-08-13 Number of Patients: 609 Recruitment Status: COMPLETED Condition: Ulcerative Colitis
NCTID: NCT03425838
Title: Endocrine Therapy Plus CDK4/6 in First or Second Line for Hormone (SONIA) Receptor Positive Advanced Breast Cancer Study Summary: Given the uncertain benefit in efficacy of adding CDK 4/6 to first rather than second line endocrine treatment, the aim of this project is to evaluate whether the sequence of an aromatase inhibitor plus CDK 4/6 in first line followed by fulvestrant in second line is superior to the sequence of an aromatase inhibitor in first line followed by fulvestrant plus CDK4/6 in second line. Sponsor: Borstkanker Onderzoek Groep Intervention: CDK 4/6 inhibitor Start Date: 2017-11-09 Last Updated: 2023-08-18 Number of Patients: 1050 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Neoplasm Female
NCTID: NCT04754672
Title: Aerobic Fitness or Muscle Mass Training to Improve Colorectal Cancer Outcome Study Summary: Evidence from randomized controlled trials shows that exercise during cancer treatment benefits physical fitness, fatigue and quality of life. Since the effect of exercise on clinical outcome is currently unknown, exercise is not included as integral part of standard cancer care. Moreover, evidence regarding the optimal exercise prescription in terms of type and dose is lacking. To maintain quality of life in patients receiving palliative treatment with chemotherapy, toxicity-induced modifications in the prescribed chemotherapy dose are common. Such modifications - occurring in 40% of patients with metastatic colorectal cancer - may reduce benefit of treatment. The investigators hypothesize that exercise prevents chemotherapy dose modifications by reducing toxicity and enhancing psychological strength. Additionally, based on studies in rodents and preliminary data in patients with cancer, the researchers hypothesize that exercise has beneficial effects on the functionality of the natural killer cells, which play an important role in the innate immune defense against cancer. Both, fewer dose modifications and improved immune function may improve progression-free survival. This study is a three-armed trial comparing resistance exercise, aerobic interval exercise and usual care in patients with metastatic colorectal cancer to select the optimal exercise prescription for preventing chemotherapy dose modifications. The trial will use a Bayesian adaptive multi-arm multi-stage design with several interim analyses after which an ineffective study arm can be dropped early. This novel design makes the trial more efficient and reduces patients’ exposure to suboptimal study arms. Evidence regarding the exercise effects on i) clinical outcome, ii) the optimal exercise prescription, and iii) the underlying mechanisms, elucidates the potential of exercise to boost benefit from chemotherapy treatment. This evidence provides leads to improve progression-free survival and quality of life of patients suffering from one of the leading causes of cancer death worldwide. Sponsor: Radboud University Medical Center Intervention: Continuous aerobic and resistance exercise intervention Start Date: 2021-03-02 Last Updated: 2023-11-18 Number of Patients: 228 Recruitment Status: RECRUITING Condition: Colorectal Cancer
NCTID: NCT02172872
Title: “InDACtion” vs “3+7” Induction in AML Study Summary: Older patients with acute myeloid leukemia (AML) have a small (< 10%) chance of long-term survival. Despite the treatment of elderly AML patients with intensive chemotherapy, the survival has not been improved during the last decades. The purpose of this study is to determine whether frontline therapy with a 10-day decitabine schedule provides a better survival than standard intensive combination chemotherapy in elderly AML patients (>= 60 years). Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: standard combination chemotherapy Start Date: 2014-11-28 Last Updated: 2023-02-15 Number of Patients: 606 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Acute Myeloid Leukemia (AML)
NCTID: NCT05239728
Title: A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022) Study Summary: The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy. The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS). Sponsor: Merck Sharp & Dohme LLC Intervention: Belzutifan Start Date: 2022-03-15 Last Updated: 2023-11-28 Number of Patients: 1800 Recruitment Status: RECRUITING Condition: Carcinoma, Renal Cell
NCTID: NCT04608318
Title: Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (CLL) Study Summary: The aim of this study is to compare the efficacy of continuous ibrutinib monotherapy with fixed-duration venetoclax plus obinutuzumab and fixed-duration ibrutinib plus venetoclax by measuring progression-free survival (PFS) in patients with previously untreated CLL. Sponsor: German CLL Study Group Intervention: Ibrutinib Start Date: 2021-03-01 Last Updated: 2023-02-23 Number of Patients: 897 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Chronic Lymphoid Leukemia
NCTID: NCT00314977
Title: Sequential vs Upfront Intensified Neoadjuvant Chemotherapy in Patients With Large Resectable or Locally Advanced Breast Cancer. Study Summary: 2 different treatment schedules may be used for neoadjuvant chemotherapy in breast cancer using adriamycin, cyclophosphamide and taxotere. The most optimal sequence- concurrent or sequential- is however unclear. The aim of the study is to compare the efficacy and tolerability of neoadjuvant chemotherapy with AC followed by T(adriamycin, cyclophosphamide, taxotere) versus TAC ( with upfront T) in patient with large resectable or locally advanced breast cancer. Sponsor: Radboud University Medical Center Intervention: Doxorubicin Start Date: 2006-02 Last Updated: 2010-03-18 Number of Patients: 200 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02603432
Title: A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100) Study Summary: The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy. Sponsor: Pfizer Intervention: Avelumab Start Date: 2016-04-25 Last Updated: 2023-06-06 Number of Patients: 700 Recruitment Status: COMPLETED Condition: Urothelial Cancer
NCTID: NCT05216328
Title: Prevention of Opioid-induced Constipation in Patients With Advanced Cancer Study Summary: More than 70% of patients with cancer in the palliative phase have pain that often requires treatment with opioids (morphine-like agents). Constipation occurs in 59% of patients treated with opioids. Opioid-induced constipation (OIC) has consequences that range from daily discomfort with social insecurity and disability to intestinal obstruction. It leads to limitations in self-management, a reduced quality of life and a risk of the need for more care. In the guideline “Diagnosis and treatment of pain in patients with cancer” it is recommended to start preventively with an osmotic laxative such as macrogol/electrolytes or magnesium hydroxide when starting opioids. Macrogol/electrolytes has been proven to be effective for OIC, but is sometimes perceived by patients as unpleasant due to its taste. Magnesium hydroxide, which is less commonly prescribed for OIC, has a neutral taste. Although it is mentioned in the guideline, it is not studied for the treatment of OIC and also not officially registered for this. To support the advice of the guideline and to prove that a choice is possible, it is important to investigate whether there are differences in effectiveness and/or side effects between macrogol/electrolytes and magnesium hydroxide in the prevention of OIC. The aim of this study is to compare macrogol/electrolytes with magnesium hydroxide in the prevention of opioid-induced constipation in patients with cancer in the palliative (incurable) phase, who start opioids because of pain. The choice of laxative is determined by drawing lots (randomisation). After two weeks, its effect will be assessed and will be presented as the percentage of patients who have not developed constipation after starting opioids. If the laxative, as assigned by lot, is described as satisfactory by the patient, the patient can continue with the drug that the patient used, after the study through regular prescription. The investigators will ask the patients in the study about their satisfaction with the laxative used, any side effects and the degree of pain. Furthermore, the appeal to care for possible constipation will be examined. Because the best attainable quality of life in the palliative phase is the objective of all care, the investigators will also measure this perceived quality with a questionnaire in this study. The results of this study will lead to the best achievable prevention of opioid constipation in patients with cancer in the palliative phase. Sponsor: Amsterdam UMC, location VUmc Intervention: Macrogol Only Product in Oral Dose Form Start Date: 2022-12-02 Last Updated: 2023-10-31 Number of Patients: 330 Recruitment Status: RECRUITING Condition: Constipation, Opioid-Induced
NCTID: NCT01598402
Title: Efficacy of Prophylactic Treatment With Antibiotics During Concomitant Chemoradiotherapy in Patients With Head and Neck Cancer to Prevent Aspiration Pneumonia Study Summary: Patients with locally advanced head and neck cancer treated with chemo-radiotherapy have (during and shortly after this treatment) a high risk of developing pneumonia by aspiration. This pneumonia is often associated with a hospital admission and affects the quality of life. The purpose of the study, is to determine whether prophylactic antibiotics may decrease the development of pneumonia. Prophylactic antibiotics means that there are no signs of pneumonia are already Sponsor: Radboud University Medical Center Intervention: amoxicillin/clavulanic acid suspension Start Date: 2011-12 Last Updated: 2013-07-15 Number of Patients: 106 Recruitment Status: UNKNOWN Condition: Head and Neck Cancer
NCTID: NCT02271828
Title: Omitting Sentinel Node Procedure in Breast Cancer Patients Undergoing Breast Conserving Therapy Study Summary: STUDY AIM To decrease the number of breast cancer patients receiving over treatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life. PRIMARY OBJECTIVE To determine whether omitting the sentinel lymph node procedure is not inferior to the current axillary staging regimen in clinically node negative breast cancer patients undergoing breast conserving therapy, in terms of regional recurrence rate. HYPOTHESIS The sentinel lymph node procedure can be safely omitted in clinically node negative breast cancer patients undergoing breast conserving therapy. This will lead to a decreased axillary morbidity rate, with a non-inferior regional recurrence-, distant-disease free- and overall survival rates. Sponsor: Maastricht University Medical Center Intervention: Sentinel lymph node procedure Start Date: 2015-04 Last Updated: 2018-05-04 Number of Patients: 1644 Recruitment Status: RECRUITING Condition: Breast Neoplasms
NCTID: NCT02103244
Title: Validation of an Adjusted Dosing Algorithm of Carboplatin Study Summary: An adjusted dosing algorithm for the dosing of the anticancer drug carboplatin has been developed, that accounts for high BMI, low serum creatinine values and maximal calculated renal function. The hypothesis is that this new dosing algorithm provides a more accurate and safe dose than dosing according to the old standard of care. Sponsor: Rijnstate Hospital Intervention: Carboplatin Start Date: 2014-09 Last Updated: 2014-04-03 Number of Patients: 24 Recruitment Status: UNKNOWN Condition: Cancer
NCTID: NCT03638440
Title: Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With OIC. Study Summary: This is a single-arm, open label, multinational, multicentre, prospective, real world observational study of Naloxegol in adult subjects with Opioid Induced Constipation (OIC) in patients receiving Naloxegol in routine clinical practice. Subjects who are receiving Naloxegol (prescribed by their physician according to the SmPC, which recommends that all currently used maintenance laxative therapy should be halted) during the enrolment period may be eligible for enrolment into the study. Sponsor: Kyowa Kirin Pharmaceutical Development Ltd Intervention: Naloxegol Start Date: 2018-08-16 Last Updated: 2022-05-16 Number of Patients: 183 Recruitment Status: COMPLETED Condition: Opioid Induced Constipation
NCTID: NCT00637624
Title: N-AcetylCysteine vs. Placebo to Prevent Neurotoxicity Induced by Platinum Containing Chemotherapy Study Summary: In this study we want to investigate the efficacy of N-acetylcysteine (NAC), which is an anti-oxidant, in the prevention of cisplatin-induced neural toxicity, in patients treated for lung cancer with chemotherapy containing cisplatin. Sponsor: Rijnstate Hospital Intervention: N-Acetylcysteine Start Date: 2008-03 Last Updated: 2022-08-25 Number of Patients: 69 Recruitment Status: TERMINATED Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT02109913
Title: Analysis of Tumor Tissue and Circulating Genetic Material in the Blood to Obtain Further Insight in the Effectiveness of Everolimus When Combined With Exemestane Study Summary: The purpose of this study is to determine whether biomarkers could be found to gain more insight in tumor characteristics in order to predict which patients will have a high chance of a long progression-free survival. Postmenopausal patients with advanced metastatic breast cancer who have progressed on anastrozole or letrozole will be eligible for this study. Sponsor: Amsterdam UMC, location VUmc Intervention: Everolimus plus Exemestane Start Date: 2014-03 Last Updated: 2019-10-14 Number of Patients: 175 Recruitment Status: UNKNOWN Condition: Hormone Receptor Positive Malignant Neoplasm of Breast
NCTID: NCT05480735
Title: EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy Study Summary: Currently, the potential value of a multimodal prehabilitation program in bladder cancer has not been extensively studied. The investigators designed the ENHANCE study to assess the effect of a structured multimodal prehabilitation program in 154 patients with bladder cancer on the number (primary endpoint) and severity of complications within 90 days, length of hospital stay, readmissions, physical fitness, muscle strength, physical functioning, nutritional status, smoking behaviour, anxiety and depression, fatigue, quality of life, physical activity, tumor tissue characteristics, and healthcare costs. Sponsor: The Netherlands Cancer Institute Intervention: Prehabilitation Start Date: 2022-08-11 Last Updated: 2022-10-31 Number of Patients: 154 Recruitment Status: RECRUITING Condition: Bladder Carcinoma
NCTID: NCT00536081
Title: Various G-CSF Regimens to Prevent Infection During Chemotherapy Study Summary: The purpose of this study is to prevent chemotherapy-related febrile neutropenia, prophylaxis with antibiotics and granulocyte colony-stimulating factor (G-CSF) have proven efficacious <math display="block">1-3</math>. G-CSF has only few side effects, but is expensive. In 2006, updated G-CSF guidelines conclude that primary G-CSF prophylaxis has clinical benefits for and should be offered to patients at a more than 20% risk of febrile neutropenia. Based on many positive and few negative trials, one can consider the use of taxanes as standard of care in the adjuvant setting in node-positive breast cancer. Taxanes (with or without anthracyclines) have an increased risk for febrile neutropenia. The updated guidelines and changes in daily clinical practice will have a significant impact on the investigators health care resources. There is a higher risk of febrile neutropenia for the first chemotherapy cycle compared to subsequent cycles in small cell lung cancer patients. Also in advanced breast cancer the majority of first observed episodes of febrile neutropenia occur in the initial chemotherapy cycles Irrespective of tumour type or chemotherapy regimen, the risk of febrile neutropenia is highest during the first two cycles of chemotherapy. Thereafter, the risk rapidly declines, and the benefit of G-CSF largely seems to disappear. So, in order to improve the cost-effective administration of primary G-CSF prophylaxis, it is justified to assess whether G-CSF prophylaxis can be limited to the first two chemotherapy cycles as compared to the current practice of continuous G-CSF prophylaxis. Sponsor: Academisch Ziekenhuis Maastricht Intervention: pegfilgrastim Start Date: 2008-01 Last Updated: 2019-11-06 Number of Patients: 172 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT03905369
Title: Focus on Values to Stimulate Shared Decisions Study Summary: Most patients with non-medullary thyroid carcinoma (TC) achieve remission after primary treatment. Nonetheless, 30% develop recurrent disease and/or distant metastases resulting in worse survival. Patients with low- and intermediate-risk, whilst having a good prognosis, generally undergo similar primary treatment as those with a high-risk disease and face the risk of complications and burden of treatment, without a proven benefit in long-term outcome. For these patients, current guidelines state that less aggressive treatment (e.g. hemi-thyroidectomy vs. total thyroidectomy, and selective use of radioiodine (RAI) therapy), and tailored follow-up can be equally acceptable leaving room for patients’ preferences. For high- risk patients, important unanswered question regard the optimal timing of starting tyrosine kinase inhibitors (TKI). For those who are asymptomatic or only mildly symptomatic, starting the treatment too early may expose them to side effects and impair quality of life, without evidence of a survival benefit. Different patients have different views on these decisions, and so do physicians. Therefore, care should honour preferences and values of individual patients, and care should involve patients through shared decision making (SDM). The principle of SDM is twofold: 1. physicians provide patients with information on the existing options, and 2. help patients identify their preferences considering their individual values and needs. This involves important life values, for instance the desire to do everything possible, or to minimise complaints. Addressing patients’ treatment-related values is arguably the most difficult part of SDM so patient values are less likely to be discussed and honoured in a consultation. Current tools improve values deliberation but their effects are clearly insufficient. Tools should be integrated and applied in consultations to increase effectiveness. To strengthen values deliberation with TC as an example, a multifaceted intervention, COMBO, is proposed including 1) a patient values clarification exercise, named SDM-booster, 2) a physician values deliberation training using the SDM-booster, and 3) a patient decision aid. The SDM-booster strengthens values deliberation by 1) strengthening and clarifying patients’ values and preferences, 2) communicating patients’ values in the consultation, 3) serving as a focus in the values deliberation training. Sponsor: Radboud University Medical Center Intervention: Decision aid and SDM booster Start Date: 2020-03-01 Last Updated: 2023-04-03 Number of Patients: 128 Recruitment Status: RECRUITING Condition: Thyroid Cancer
NCTID: NCT03924869
Title: Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867) Study Summary: The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with unresected stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC). The primary study hypotheses are: # SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution), and # SBRT plus pembrolizumab prolongs Overall Survival (OS) compared to SBRT plus placebo. Sponsor: Merck Sharp & Dohme LLC Intervention: Stereotactic Body Radiotherapy (SBRT) Start Date: 2019-06-25 Last Updated: 2023-11-27 Number of Patients: 530 Recruitment Status: RECRUITING Condition: Non-Small Cell Lung Cancer
NCTID: NCT02623101
Title: Reflectance Confocal Microscopy in Basal Cell Carcinoma Study Summary: Skin cancer is the most common cancer and its incidence is increasing rapidly. The rising number of skin cancer may result in long waiting lists for consultation at departments for dermatological care and in increasing health care costs. In case of suspicion on skin cancer it is of utmost importance to diagnose and treat in an early phase, preferable in a patient friendly manner. Skin cancer comprises melanoma and non-melanoma skin cancer (NMSC: basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and its precursors actinic keratosis (AK) and Bowen disease). As BCC is the most common skin cancer type with an estimated incidence of 51,000 new tumors in 2015 (The Netherlands), this study will focus on this skin cancer type. In case of suspicion on BCC, at present, the pathological examination of a biopsy is the gold standard for diagnosing a BCC. With the implementation of non invasive diagnosis by reflectance confocal microscopy (RCM) in routine patient care settings the diagnosis can be assessed at the first consultation in a non-invasive way and the patient can be treated instantly. Overall, the aim of this study is to investigate whether reflectance confocal microscopy can correctly identify the subtype of basal cell carcinoma. Study design: Randomized controlled trail. Comparison with usual care: punch biopsy and excision. Sponsor: Radboud University Medical Center Intervention: Reflectance confocal microscopy Start Date: 2015-12-01 Last Updated: 2019-09-20 Number of Patients: 288 Recruitment Status: COMPLETED Condition: Carcinoma, Basal Cell
NCTID: NCT03898180
Title: Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011) Study Summary: The purpose of this study is to evaluate the efficacy and safety of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in the treatment of cisplatin-ineligible participants with a Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10, or in participants ineligible for any platinum-containing chemotherapy regardless of CPS, with advanced/unresectable or metastatic urothelial carcinoma (UC). The primary hypotheses for this study are that: # Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR), and # Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Overall Survival (OS). With Amendment 3 (effective: September <math display="block">Sep</math>-24-2021) participants discontinued lenvatinib and placebo; participants who remained on treatment in the study arms received open-label pembrolizumab. With Amendment 3 the external Data Monitoring Committee was discontinued. With Amendment 4 (effective: December-5-2022) Second Course will no longer be offered. Any participant receiving Second Course treatment prior to initiation of Amendment 4 will be able to complete treatment as planned. With Amendment 4 study participation will end after the final administration of pembrolizumab. Participants who either complete 35 administrations of pembrolizumab or discontinue pembrolizumab will discontinue from the study following the safety follow-up visit. AEs and spontaneously reported pregnancies will be reported and followed per protocol. All participants in efficacy follow-up prior to initiation of Amendment 4 will stop efficacy assessments and be discontinued from the study. All participants in survival follow-up prior to initiation of Amendment 4 are considered to have completed the study and should have a final survival contact. The overall study ends when the last participant completes the last study-related contact or visit, withdraws from the study, or is lost to follow-up. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-05-06 Last Updated: 2023-10-31 Number of Patients: 487 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Urothelial Carcinoma
NCTID: NCT00377780
Title: Liposomal Doxorubicin, Trastuzumab, and Docetaxel in HER2 Positive Metastatic Breast Cancer Study Summary: This is an open phase II study evaluating the efficacy and safety of the non pegylated liposomal doxorubicin (Myocet®), trastuzumab (Herceptin®), and docetaxel (Taxotere®) combination as first-line treatment of patients with metastatic HER2
eu positive breast cancer.
Sponsor: Laurence J.C. van Warmerdam Intervention: Non pegylated liposomal doxorubicin, trastuzumab, docetaxel Start Date: 2006-08 Last Updated: 2015-09-23 Number of Patients: 60 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT02925234
Title: The Drug Rediscovery Protocol (DRUP Trial) Study Summary: This is a prospective, non-randomized clinical trial that aims to describe the efficacy and toxicity of commercially available, targeted anticancer drugs* prescribed for treatment of patients with advanced cancer with a potentially actionable variant as revealed by a genomic or protein expression test. The study also aims to simplify patient access to approved targeted therapies that are contributed to the program by collaborating pharmaceutical companies and to perform next generation sequencing on tumor biopsies for biomarker analyses. Eligible patients have an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma for which standard treatment options are no longer available and acceptable performance status and organ function. A genomic or protein expression test must have been performed on the tumor and the results must identify at least one potentially actionable molecular variant as defined in the protocol. Results from the molecular profiling test will be used to determine an appropriate drug(s) from among those available in the protocol. The choice of drug will be supported by a list of potential profiles, a molecular tumor board, a knowledge library and by study coordinators for review and approval of the match. The protocol-specified treatment will be administered to the patient once any drug-specific eligibility criteria are confirmed and a fresh pre-treatment biopsy is performed for future genetic studies. All patients who receive treatment with a drug available in the protocol will be followed for standard efficacy outcomes including tumor response, progression-free and overall survival as well as duration of treatment. In addition, treatment related toxicity will be evaluated. Sponsor: The Netherlands Cancer Institute Intervention: Panitumumab Start Date: 2016-08 Last Updated: 2023-02-13 Number of Patients: 1550 Recruitment Status: RECRUITING Condition: Cancer
NCTID: NCT00041301
Title: Assessing Quality of Life of Patients With Prostate Cancer Study Summary: RATIONALE: Quality of life assessment in patients undergoing prostate cancer treatment may help determine the intermediate and long-term effects of the treatment on these patients. PURPOSE: Clinical trial to study the effectiveness of two questionnaires in assessing quality of life of patients who have prostate cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: QoL assessment Start Date: 2002-03 Last Updated: 2012-08-27 Number of Patients: 625 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT04487080
Title: A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer Study Summary: The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions <math display="block">Exon 19del</math> or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC). Sponsor: Janssen Research & Development, LLC Intervention: Amivantamab Start Date: 2020-09-30 Last Updated: 2023-11-08 Number of Patients: 1074 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT05907057
Title: An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy. Study Summary: The purpose of this study is to learn more about the safety and efficacy of ivosidenib taken with azacitidine to treat adult patients with acute myeloid leukemia (AML) who are presenting a gene mutation called IDH1 (isocitrate dehydrogenase1 mutation-positive <math display="block">IDH1m</math>) and cannot receive treatment with intensive chemotherapy (IC). Sponsor: Servier Affaires Médicales Intervention: Ivosidenib 500mg Oral Tablet Start Date: 2023-06-14 Last Updated: 2023-11-18 Number of Patients: 245 Recruitment Status: RECRUITING Condition: Acute Myeloid Leukemia (AML)
NCTID: NCT02208544
Title: FDG-PET/CT in Evaluation of Cytological Indeterminate Thyroid Nodules to Prevent Unnecessary Surgery (EfFECTS) Study Summary: The purpose of this study is to determine whether the use of molecular imaging using FDG-PET/CT could prevent unnecessary diagnostic thyroid surgery in case of indeterminate cytology during fine-needle aspiration biopsy. Sponsor: Radboud University Medical Center Intervention: Diagnostic Thyroid Surgery Start Date: 2015-07-16 Last Updated: 2022-05-04 Number of Patients: 132 Recruitment Status: COMPLETED Condition: Thyroid Nodule
NCTID: NCT02928224
Title: Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer Study Summary: This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib + cetuximab plus or minus binimetinib versus Investigator’s choice of either irinotecan/cetuximab or FOLFIRI/cetuximab, as controls, in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting. The study contains a Safety Lead-in Phase in which the safety and tolerability of encorafenib + binimetinib + cetuximab will be assessed prior to the Phase 3 portion of the study. Sponsor: Pfizer Intervention: Encorafenib Start Date: 2016-10-13 Last Updated: 2023-05-06 Number of Patients: 702 Recruitment Status: COMPLETED Condition: BRAF V600E-mutant Metastatic Colorectal Cancer
NCTID: NCT05215340
Title: Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations Study Summary: This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC). Sponsor: Daiichi Sankyo, Inc. Intervention: Datopotamab Deruxtecan Start Date: 2022-03-04 Last Updated: 2023-11-18 Number of Patients: 740 Recruitment Status: RECRUITING Condition: Metastatic Non Small Cell Lung Cancer
NCTID: NCT05224141
Title: Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008, KEYVIBE-008) Study Summary: This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab/Vibostolimab Co-Formulation Start Date: 2022-03-24 Last Updated: 2023-10-10 Number of Patients: 450 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Small Cell Lung Carcinoma
NCTID: NCT02364999
Title: A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLC Study Summary: This is a multinational, double-blind, randomized, parallel-group Phase 3 clinical trial evaluating the efficacy and safety of bevacizumab-Pfizer plus paclitaxel and carboplatin versus bevacizumab-EU plus paclitaxel and carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC. Sponsor: Pfizer Intervention: Bevacizumab-Pfizer Start Date: 2015-04 Last Updated: 2019-02-07 Number of Patients: 719 Recruitment Status: COMPLETED Condition: Non-Small Cell Lung Cancer
NCTID: NCT03033511
Title: A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU) Study Summary: This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy. Sponsor: AbbVie Intervention: Placebo for dexamethasone Start Date: 2017-02-07 Last Updated: 2021-07-29 Number of Patients: 748 Recruitment Status: TERMINATED Condition: Small Cell Lung Cancer
NCTID: NCT05338970
Title: HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy Study Summary: Disease progression is typical for patients with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC). Standard platinum-based chemotherapy offers limited efficacy and an unfavorable safety profile.There is an urgent need for more effective and tolerable therapies for patients with EGFRm NSCLC who have exhausted available targeted therapies. Clinical evidence suggest that patritumab deruxtecan constitutes a promising investigational therapy for patients with EGFRm NSCLC. Sponsor: Daiichi Sankyo, Inc. Intervention: Patritumab Deruxtecan Start Date: 2022-05-10 Last Updated: 2023-11-18 Number of Patients: 560 Recruitment Status: RECRUITING Condition: Nonsquamous Non-small Cell Lung Cancer
