Gorinchem

Researchers are studying patients with non-metastatic stage II colon cancer who are part of the Dutch ColoRectal Cancer cohort PLCRC and who consented to additional blood samples. The study aims to evaluate how many patients with detectable circulating tumor DNA ctDNA after surgery begin adjuvant chemotherapy. This observational and interventional trial includes patients who do not have a standard indication for chemotherapy and involves a randomized design to compare ctDNA-guided treatment with standard care. Patients are randomly assigned to one of two groups the ctDNA-based treatment group or the standard care group. In the ctDNA group, blood samples taken after surgery are analyzed for ctDNA. Those with detectable ctDNA are offered 3 months of adjuvant chemotherapy using CAPOX a combination of fluoropyrimidine and oxaliplatin. Patients without detectable ctDNA receive routine follow-up care. The standard care group receives routine follow-up without knowledge of their ctDNA results. Participants will have blood collected before surgery, after surgery, and during follow-up. Researchers will monitor who starts chemotherapy within 8 to 12 weeks after surgery and will track recurrence rates, disease-free survival, overall survival, time to recurrence, quality of life, and cost-effectiveness over several years. Follow-up assessments occur up to 10 years, allowing detailed long-term evaluation of treatment impact and patient outcomes.

Researchers are evaluating chemotherapy dosing strategies in older patients aged 70 years and above who have metastatic colorectal cancer and are eligible for first-line palliative chemotherapy. This phase III randomized controlled trial aims to compare upfront dose-reduced chemotherapy with standard full-dose chemotherapy, focusing on progression-free survival PFS. Patients are assessed using the Geriatric 8 G8 questionnaire to determine their risk of chemotherapy toxicity, which guides treatment assignment. The study seeks to balance treatment effectiveness with minimizing toxicity, hospital admissions, and maintaining quality of life QoL and physical functioning. Participants classified as low risk for toxicity G8 score 15 or higher are randomized to receive either doublet chemotherapy a fluoropyrimidine combined with oxaliplatin at full dose or with a 25% dose reduction upfront. Those at high risk G8 score 14 or lower or judged high risk by their oncologist receive fluoropyrimidine monotherapy either at full dose or with a 25% dose reduction. The study also allows the addition of targeted treatments like bevacizumab or EGFR inhibitors. Dose adjustments are made for patients with moderate kidney impairment. Chemotherapy is given orally or intravenously on schedules varying between every two and three weeks, depending on the regimen. Participants will be closely monitored throughout treatment, with assessments including radiological or clinical evaluations for disease progression, quality of life and physical functioning questionnaires at 1, 3, 6, and 12 months, and tracking of chemotherapy toxicity, overall survival, treatment cycles, dose changes, hospital admissions, and cumulative drug dosage. Safety and cost-effectiveness will also be evaluated over an average study duration of eight months and up to one year for some outcomes. The study plans to include 587 patients and will continue until December 2028.

Researchers are investigating whether taking breaks from the standard combination therapy of daratumumab, lenalidomide, and dexamethasone Dara-Rd for newly diagnosed multiple myeloma patients affects survival and quality of life. This study aims to compare continuous treatment versus planned treatment-free intervals to see if stopping therapy temporarily may reduce side effects, allow recovery from toxicity, and improve overall well-being while controlling the disease. Participants who have completed 12 cycles of Dara-Rd with at least a partial response and no signs of disease progression will be randomly assigned to one of two groups. One group will continue Dara-Rd therapy without interruption until disease progression, while the other group will stop treatment temporarily and restart it at biochemical progression, continuing until disease progression. The trial is open-label and will follow patients for several years to assess outcomes. Throughout the study, researchers will monitor participants event-free survival and progression-free survival for up to about 57 and 69 months, respectively. Additional assessments include side effect burden, patient-reported quality of life, treatment costs, treatment-free interval length, response times, and survival after second-line therapy. Regular evaluations will help determine how treatment interruption affects toxicity, dose intensity, and overall treatment outcomes over the long term.

Researchers are investigating how various factors beyond tumor stage, such as biochemical, histopathological, genomic, environmental, and clinical characteristics, affect the outcomes of patients diagnosed with colorectal cancer CRC, small bowel cancer, and anal cancer. This observational study aims to collect detailed information from diagnosis through long-term follow-up to better understand prognosis and treatment effects in both early and late-stage cancers. The study addresses the gap between clinical trial populations and real-world patients by including a broader patient group treated in general practice. Participants will be followed prospectively from their initial diagnosis until death. Data collection includes medical history, clinical parameters, imaging, pathology, tumor details, treatments, hospital stays, interventions, and adverse events. With separate consent, patient-reported quality of life and work ability information will also be gathered. Additionally, biological samples obtained during routine care may be collected for further observational and molecular research. This cohort serves as a platform for evaluating new interventions through a Trials within Cohorts TwiCs design. Throughout up to ten years of follow-up, participants will undergo assessments of progression-free survival, disease-free survival, overall survival, and serious adverse events. Quality of life and work ability are assessed at intervals of 3, 6, 12, 24, 36, and 48 months. This extensive data collection supports a wide range of research aims including prognostic studies, molecular analyses, comparisons of new treatments, and health policy evaluations. The study provides a comprehensive view of treatment outcomes and patient experiences in everyday clinical settings.

Researchers are studying the use of targeted anticancer drugs in patients with advanced cancer who have specific molecular changes in their tumors. This study aims to describe how well these targeted drugs work and their side effects when prescribed based on a tumors genetic or protein profile. It focuses on patients with advanced solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma who have no standard treatment options left and have acceptable health status and organ function. Participants receive targeted cancer drugs selected from a list of approved therapies matched to their tumors molecular profile. A molecular tumor board and study coordinators help determine the best drug choice. Before treatment, patients provide a fresh tumor biopsy for genetic analysis. The study includes many drugs, including Panitumumab, Olaparib, Dabrafenib, and several others, some given alone or in combination, according to the tumor profile. Treatment eligibility and drug-specific criteria are confirmed before starting therapy. Throughout the study, participants are monitored for tumor response, disease stability, survival, and treatment side effects. Researchers collect data on tumor changes, progression-free survival, overall survival, and how long patients remain on treatment. Next generation sequencing on tumor samples provides additional biomarker information. The study continues to follow patients for up to one year after treatment to assess outcomes and safety.

Researchers are evaluating the impact of a combined exercise and nutrition program on quality of life in patients with incurable gastroesophageal adenocarcinoma, particularly after their first-line cancer treatment has failed. This study focuses on patients with metastatic or recurrent disease, aiming to address declines in muscle mass, physical ability, and nutritional health, which can worsen quality of life. The trial seeks to understand whether improving physical capacity and nutrition can benefit patients in this challenging condition. Participants will be randomly assigned to one of two groups one receiving standard medical care, including nutritional support and general advice on physical activity the other receiving this usual care plus a 12-week intervention involving supervised exercise sessions twice weekly with an oncology physiotherapist and biweekly nutritional assessments by a dietician. The exercise includes aerobic and resistance training tailored to individual fitness, alongside education to increase daily activity, supported by activity trackers. Nutritional guidance follows established cancer-related nutrition guidelines, emphasizing protein intake post-exercise. Throughout the study, participants will complete questionnaires on quality of life at baseline, 6 weeks, and every 12 weeks up to one year. Measures such as aerobic capacity, muscle strength, body composition, nutritional status, physical activity levels, and treatment effects will be regularly assessed. The trial also monitors treatment toxicity, progression-free and overall survival, and performance status. The full observation period extends up to one year after the intervention, ensuring comprehensive evaluation of outcomes and safety.