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Found 6 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the safety and effectiveness of ifinatamab deruxtecan (I-DXd) alone or combined with other treatments in people with metastatic castration-resistant prostate cancer (mCRPC). This study aims to understand how well patients tolerate the treatment, find a safe dose for combining I-DXd with other drugs, and measure prostate-specific antigen (PSA) levels during treatment. The study is part of a larger master screening protocol and includes patients with confirmed prostate adenocarcinoma who have progressive disease despite prior therapies. Participants receive treatments including I-DXd given through intravenous infusion, sometimes combined with other drugs such as docetaxel (IV), MK-5684, abiraterone, or enzalutamide (all oral). Before each I-DXd dose, patients take premedication to prevent nausea and vomiting. The study includes both a safety lead-in phase and an efficacy phase, with ongoing monitoring for side effects and tolerability. The combination therapies are carefully dosed and scheduled according to the study protocol. During the study, participants undergo regular assessments to monitor side effects, measure PSA response, and track any dose-limiting toxicities. Safety is closely followed, particularly during the first 21 days for combination treatments, and throughout up to 54 months for long-term outcomes. Researchers also observe if participants discontinue treatment due to adverse events. The study requires ongoing visits and evaluations to ensure participant health and collect data on treatment effects over time.
Actively Recruiting
Anastomotic leakage (AL) is a serious complication after colon surgery, linked to higher mortality, lower quality of life, and increased healthcare costs. This research evaluates whether preventive endovascular stenting of a narrowed superior mesenteric artery (SMA) can reduce the risk of AL in patients aged 40 and older undergoing elective colon resection with primary anastomosis. The study is a nationwide multicenter randomized controlled trial involving patients with over 50% SMA stenosis, aiming to improve surgical outcomes and survival. Participants are randomly assigned to either receive preventive percutaneous transluminal angioplasty with a covered stent placed in the SMA before colon surgery or to undergo colon surgery without this stenting. Both groups receive mono antiplatelet therapy with daily Ascal (carbasalate calcium) to reduce atherosclerotic risks and maintain stent patency. The stenting procedure is ideally done within two weeks before surgery. Colon surgery follows standard protocols, and some centers use intraoperative fluorescence angiography to assess blood flow. During the 12-month follow-up, researchers monitor the occurrence of clinically relevant AL within 90 days after surgery as the primary outcome. They also assess AL severity, delayed leakage, surgical complications, hospital stays, readmissions, mortality, quality of life, and health economic impacts. Patient-reported outcomes are collected at multiple points post-surgery through questionnaires. Safety and stent performance are closely observed, with comprehensive data collected to evaluate the intervention's effectiveness and cost implications.
Actively Recruiting
Researchers are investigating how to best measure changes in different swelling characteristics, such as water volume and skin hardness, in the lower limbs of people with lymphedema. The goal is to find reliable tools to evaluate the effects of treatments accurately and determine when these changes are clinically meaningful. This study addresses the lack of information on which edema features should be tracked and what defines a significant improvement after treatment. Participants will undergo two clinical evaluations spaced one month apart using various measurement methods chosen by an expert group for their reliability and practicality. The study focuses on both an intensive treatment group starting decongestive lymphatic therapy and a maintenance treatment group who have completed intensive therapy at least three months prior. These evaluations aim to identify which tools detect meaningful changes in lymphedema characteristics after treatment. During the study, participants will be assessed with all selected evaluation methods to monitor edema features in the lower limbs. Researchers will measure the sensitivity, specificity, and overall accuracy of these tools to understand their ability to detect real treatment effects. The study will help establish clear criteria for clinical changes in lymphedema, benefiting future patient care and treatment assessments.
Actively Recruiting
Researchers are investigating the treatment of multiple myeloma using a combination of medicines called daratumumab-lenalidomide-dexamethasone (Dara-Rd). This standard treatment in the Netherlands often suppresses the disease for a long time and continues until it stops being effective. The study aims to find out if stopping treatment temporarily, compared to continuing it without breaks, can improve quality of life by reducing side effects and allowing recovery from toxicity, without reducing survival time. The study involves patients who have completed 12 cycles of Dara-Rd treatment and have responded with at least a partial response without biochemical progression. These patients will be randomly assigned to either continue Dara-Rd treatment continuously or take a treatment-free interval. The medications involved include daratumumab injections, lenalidomide capsules, and dexamethasone. Reduced dosing of lenalidomide is allowed but not below 5 mg, and prior dexamethasone dose changes are permitted. The trial is a nationwide, open-label, randomized Phase III study. Participants will be followed for up to approximately 57 months to compare event-free survival and up to 69 months to compare progression-free survival after randomization. Researchers will monitor disease status, side effects, and overall health during this time. Patients must provide informed consent and will undergo regular assessments to evaluate the impact of continuous versus interrupted therapy on their disease and quality of life.
Actively Recruiting
Researchers are studying the changes and characteristics of the gut microbiome during chemotherapy in patients with metastatic or irresectable colorectal cancer (CRC). The study aims to explore how the gut microbiome relates to the effects of chemotherapy, as current treatments have limited overall survival and significant side effects. Understanding the microbiome could help improve treatment selection and effectiveness for CRC patients undergoing systemic anti-tumor therapy. Participants will collect fecal samples at home before starting treatment and three months after treatment begins, coinciding with response evaluations. They will also fill out questionnaires about factors that might affect the microbiome, such as antibiotic or proton pump inhibitor use. Additionally, blood samples will be collected before treatment and three months later for storage and analysis. Treatments include any combination of chemotherapy with or without anti-VEGF or anti-EGFR therapy. During the study, researchers will monitor changes in the gut microbiome and evaluate the patients' response to chemotherapy over two years. Outcome measures include prediction of response to conventional systemic anti-tumor therapy. Participants must provide informed consent and comply with study procedures, including sample collection and questionnaires. The study focuses on improving understanding of the microbiome's role in treatment outcomes and safety in metastatic or irresectable CRC.
Actively Recruiting
Researchers are evaluating the use of commercially available targeted anticancer drugs for patients with advanced cancer who have specific molecular changes in their tumors. This phase 2, non-randomized study aims to describe how effective and safe these targeted treatments are for patients whose standard treatment options have been exhausted. It also seeks to improve patient access to these drugs by collaborating with pharmaceutical companies and performing next generation sequencing on fresh tumor biopsies to identify biomarkers. Participants receive targeted therapies matched to the molecular profile of their tumors, as determined by approved genomic or protein expression tests. The choice of drug is guided by a molecular tumor board, a knowledge library, and study coordinators. The protocol requires a fresh frozen tumor biopsy before treatment, with some exceptions for brain tumor patients or those with prior tissue testing. Various targeted drugs, including single agents and combinations, are administered according to molecular findings and drug-specific criteria. During the study, patients are monitored for tumor response, disease stability, and treatment-related serious side effects over six months following treatment start. Tumor assessments follow standard criteria, and treatment outcomes such as progression-free and overall survival are tracked. Safety and toxicity are carefully evaluated, and all patients receiving protocol drugs are followed to gather data on the benefits and risks of these personalized treatments.