Gorinchem

Patients in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) with non-metastatic colon cancer that gave consent for additional blood withdrawals are enrolled in the observational PLCRC-MEDOCC substudy. In this study, blood is collected before surgery, after surgery and during follow-up. Within PLCRC-MEDOCC, patients with stage II colon cancer that are not considered to have an indication for adjuvant chemotherapy, can be included in the MEDOCC-CrEATE subcohort under the condition that they gave informed consent in PLCRC for biobanking of tissue and for future studies (Trial within Cohorts design). Patients included in MEDOCC-CrEATE will be randomized 1:1 to the (A) ctDNA-based treatment group versus (B) the standard of care group. A total of 1320 patients will be randomized. Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. All patients with detectable ctDNA will be offered adjuvant chemotherapy (3 months CAPOX). Patients with undetectable ctDNA will receive routine follow-up at the surgical department. The aim of this Trial within Cohorts study is to investigate how many patients with detectable ctDNA after surgery start with adjuvant chemotherapy.

Researchers are evaluating chemotherapy dosing strategies for older patients aged 70 years and above who have metastatic colorectal cancer and are candidates for palliative chemotherapy. This phase III, open-label, randomized controlled trial aims to compare upfront dose-reduced chemotherapy with standard full-dose chemotherapy to see if the reduced dose is not worse in terms of progression-free survival (PFS). The study also examines secondary outcomes including severe toxicity, quality of life, physical function, overall survival, treatment cycles, dose reductions, hospital admissions, cumulative dosage, and cost-effectiveness. Participants are classified based on their risk of chemotherapy toxicity using the Geriatric 8 (G8) questionnaire. Those at low risk are randomized to receive either full-dose or 25% dose-reduced doublet chemotherapy (a fluoropyrimidine combined with oxaliplatin). Patients at high risk receive either full-dose or dose-reduced monotherapy with a fluoropyrimidine. Targeted treatments like bevacizumab or EGFR inhibitors may be added. Dose adjustments are made for moderate kidney impairment. Treatments are given on schedules involving oral and intravenous chemotherapy drugs administered every 2 to 3 weeks. During the study, participants undergo assessments including clinical evaluations, laboratory tests to monitor blood counts and organ function, and questionnaires for quality of life and physical functioning. Progression-free survival is tracked for at least one year after randomization. Researchers closely monitor treatment toxicity, hospitalizations, dose modifications, and survival. The total planned enrollment is 587 patients, with follow-up for safety and effectiveness throughout the treatment period.

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.

Researchers are studying patients diagnosed with colorectal cancer, small bowel cancer, and anal cancer to better understand factors that affect treatment outcomes and survival. This study looks beyond tumor stage to explore how biochemical, genetic, environmental, and clinical factors may influence tumor recurrence and patient survival. It aims to address the gap in knowledge caused by most cancer patients not participating in clinical trials, and to validate trial results in a broader patient population. This is a prospective observational cohort study where data is collected from patients starting at their primary diagnosis and continuing until death. After informed consent, researchers gather detailed information on medical history, clinical status, imaging, pathology, tumor characteristics, treatments, hospital stays, side effects, and adverse events. Additional consent allows collection of patient-reported outcomes on quality of life and work ability, as well as biological materials like blood and tumor tissue for research and biobanking. Participants will be closely followed over time with ongoing data collection on treatment effects, clinical outcomes, and patient experiences. The study aims to provide accurate real-world data on various treatments and outcomes and to serve as a resource for future research into prognostic markers, new therapies, molecular studies, and health care policy. The main outcome measured is progression-free survival, tracked for up to 10 years, to better understand long-term treatment impact.

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.

Researchers are investigating how a combined exercise and nutritional program affects quality of life in patients with incurable cancer of the esophagus or stomach. These patients often face declining quality of life due to reduced muscle mass, physical ability, and nutritional health. The study aims to see if improving physical fitness and nutrition can help maintain or enhance their quality of life after first-line treatment has failed. This trial includes 196 patients with metastatic gastroesophageal cancer, who will be randomly assigned to receive either standard care or standard care plus the combined intervention. The intervention group participates in supervised exercise sessions twice a week for 12 weeks with a trained physiotherapist, focusing on aerobic and resistance training tailored to their fitness level. They also get guidance on increasing daily activity and receive an activity tracker to monitor movement. Every two weeks, a dietician assesses their nutritional status and provides personalized dietary advice based on cancer nutrition guidelines. Participants are encouraged to consume 15-25 grams of protein within 1-2 hours after exercise to support muscle health. The control group receives standard care without these additional interventions. Participants will be involved in the study for up to one year, with quality of life evaluated at the start, after 6 weeks, and then every 12 weeks. Assessments include questionnaires related to their physical and nutritional status, tracking of daily activity, and ongoing monitoring of their well-being. Safety and adherence are carefully observed, with the study designed to understand both the benefits and any risks of this combined approach in this vulnerable patient group.