Winterswijk

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 evaluating the use of a Bayesian network model called ENDORISK to improve preoperative risk assessment of lymph node metastasis in patients with early stage endometrial cancer. The study aims to see if using ENDORISK in daily clinical practice enhances risk stratification compared to standard care. This includes assessing patient decisions about lymph node evaluation and shared decision-making between patients and doctors. Participants receive personalized risk assessments for lymph node metastases using the ENDORISK model. Treatment plans, including hysterectomy with bilateral salpingo-oophorectomy and possible lymph node surgery, are tailored based on this risk. The study is conducted in two oncology regions using a stepped wedge design with one-year intervals between implementation phases. During the study, patients complete digital or paper questionnaires to evaluate preoperative information and shared decision-making outcomes. Researchers track the proportion of patients undergoing lymph node staging, positive predictive value for lymph node metastases, survival rates, quality of life, experiences with the ENDORISK model, and regional care costs. Follow-up continues up to 12 weeks post-operation to assess these outcomes.

Researchers are conducting a nationwide prospective study in the Netherlands focusing on patients with bladder cancer who are at high risk, including those with non-muscle-invasive, muscle-invasive, and metastatic stages of the disease. The study aims to build a research infrastructure to support both observational and interventional bladder cancer studies. It seeks to collect valuable information to better understand bladder cancer and improve future treatments. The study does not involve specific treatment interventions but serves as a platform for ongoing and future bladder cancer research. Participants include adults aged 18 years and older with any stage of bladder cancer except stage Ta. Patients provide written informed consent to join the study, which allows for their inclusion in other studies simultaneously. Participants will be followed over time, and the main outcome measured is overall survival at 10 years. This long-term follow-up helps researchers understand survival patterns and outcomes associated with bladder cancer. The study includes regular assessments and data collection to support various research projects aimed at improving care for bladder cancer patients.

Researchers are evaluating whether adding 18F-Fluorodeoxyglucose Positron Emission Tomography/Computerized Tomography (18F FDG PET/CT) scans during follow-up improves the 3-year overall survival of patients with stage III non-small cell lung cancer (NSCLC) compared to conventional CT scan surveillance. This study focuses on early detection of tumor recurrence to potentially allow curative treatments and improve survival and quality of life. It also examines secondary outcomes such as recurrence detection rates, event-free survival, cost-effectiveness, and patient experiences with additional PET/CT scans. Participants are divided into two groups: the control group receives usual care with conventional CT scans of the thoracic region at 6, 12, 18, 24, and 36 months after treatment. The intervention group receives these same CT scans plus additional whole-body 18F FDG PET/CT scans at the same follow-up visits. All participants may also receive adjuvant treatments during follow-up. Optional activities include completing quality of life questionnaires at each time point, participating in interviews about the PET/CT scans, and giving blood samples for research purposes. During the study, participants will be monitored with scheduled imaging visits at 6-month intervals up to 3 years post-treatment. Researchers will assess overall survival, detect both symptomatic and asymptomatic recurrences, evaluate quality of life, and analyze cost-effectiveness. The study includes intention-to-treat and per-protocol analyses, with survival compared using Kaplan-Meier curves. Optional interviews and blood collections provide additional data on patient experience and recurrence detection. Participants provide informed consent and their progress is carefully followed to understand the impact of additional PET/CT surveillance.