Winterswijk

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 evaluating the use of the ENDORISK Bayesian network model to improve preoperative risk assessment for lymph node metastasis in patients with early stage endometrial cancer. This study aims to see if implementing ENDORISK in everyday clinical practice enhances risk stratification compared to the current standard care. The study also looks at patient information sharing, treatment decisions, survival outcomes, quality of life, clinician experiences, and healthcare costs. Participants are divided into two groups a control group receiving standard care based on prior data, and an intervention group using the ENDORISK model to receive personalized risk assessments and treatment plans including hysterectomy with or without lymph node surgery. The model is applied during preoperative counseling to guide treatment decisions. The study is conducted over several years in two oncology regions, with the intervention introduced sequentially. During the study, participants will undergo lymph node staging if indicated, and complete questionnaires about information provision and shared decision-making up to 12 weeks after surgery. Researchers will monitor the proportion of patients choosing lymph node assessment, positive predictive value of detected metastases, survival rates over 5 years, health-related quality of life at 12 weeks and 12 months, treatment-related morbidity, clinician feedback, and regional care costs. The study starts in October 2025 and continues through October 2032.

Researchers are conducting a prospective nation-wide study in the Netherlands to observe and gather information about patients with high-risk non-muscle-invasive, muscle-invasive, and metastatic bladder cancer. This research aims to build an infrastructure to support both observational and interventional bladder cancer studies. The study is sponsored by the Prospective Bladder Cancer Infrastructure Foundation and focuses on understanding patient outcomes over time. This is an observational study without specific treatment interventions. It includes bladder cancer patients of any stage except Ta, aged 18 years or older, who provide written consent to participate. There are no exclusion criteria listed, and patients may participate in other studies simultaneously. The study period extends long-term, aiming to follow participants for up to 10 years. Participants will be monitored for overall survival as the primary outcome over 10 years. Additional outcomes include progression-free survival, recurrence-free survival over 10 years, and assessments of health-related quality of life, including cancer-specific quality of life, over 2 years. Data collection will involve regular follow-up to evaluate these outcomes and support bladder cancer research. The total participation duration could last up to several years, allowing comprehensive long-term observation.

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 evaluating the follow-up care for patients with stage III non-small cell lung cancer NSCLC. The study compares overall survival over three years between patients who receive follow-up surveillance using 18F-Fluorodeoxyglucose Positron Emission TomographyComputerized Tomography 18F FDG PETCT and those who undergo conventional CT scan surveillance. This is to determine if the addition of 18F FDG PETCT scans improves early detection of cancer recurrence and impacts survival and quality of life. Participants are randomly assigned to two groups the intervention group receives usual care plus additional whole-body 18F FDG PETCT scans at 6, 12, 18, 24, and 36 months during follow-up, while the control group receives regular follow-up with physical exams and CT scans at least every six months for two years, then yearly until three years. After the 36-month period, all patients continue usual care with CT scans. The PETCT scans follow a specific low-dose protocol covering the skull to the mid-femoral region. During the study, participants complete quality of life questionnaires at each visit and may optionally participate in interviews and blood sample collection to assess secondary outcomes. Researchers measure overall survival at three years, recurrence detection, event-free survival, cost-effectiveness, and health-related quality of life. The study involves monitoring medical resource use and patient experiences, with results analyzed using survival curves and statistical tests over the three-year follow-up period.