Terneuzen

Researchers are evaluating the safety and effectiveness of atogepant, a medication approved for adults with migraine, in children and teens aged 6 to 17 who have a history of episodic migraine. This Phase 3 study addresses the limited approved treatments available for pediatric migraine sufferers and aims to better understand atogepants impact on this younger population. Participants will be randomly assigned to one of six groups based on age and dosage. Children aged 6 to 11 will participate in a pharmacokinetic substudy to determine the appropriate dose before receiving either placebo, low-dose, or high-dose atogepant tablets once daily for 12 weeks. Teens aged 12 to 17 will be randomized to receive placebo, low-dose, or high-dose atogepant tablets daily for 12 weeks. After this period, participants may have a follow-up visit 4 weeks after their last dose or join an extension study to continue atogepant treatment for an additional 52 weeks. During the study, participants will attend regular hospital or clinic visits for medical evaluations, blood tests, side effect monitoring, and questionnaires. Researchers will measure changes in the number of migraine and headache days, medication use, quality of life, and migraine-related disability. Safety will be monitored through adverse event reporting up to 16 weeks. The total study duration includes the 12-week treatment period with possible extension and follow-up assessments.

Researchers are studying whether adjuvant chemotherapy can prevent disease recurrence in adults with high-risk rectal cancer who have detectable circulating tumor DNA ctDNA after surgery. The study aims to determine if this chemotherapy improves disease-free survival compared to standard care. Rectal cancer remains a significant cause of mortality, and while current treatments reduce local recurrence, distant recurrence rates stay high. Identifying patients with residual disease through ctDNA may help target those who might benefit from additional chemotherapy. Participants with detectable ctDNA after surgery will be randomly assigned to receive either standard care or adjuvant chemotherapy consisting of 6 cycles of FOLFOX 5FUfolinic acid and oxaliplatin every 2 weeks or 4 cycles of CAPOX capecitabine and oxaliplatin within 8 to 12 weeks after surgery. The chemotherapy treatment lasts about 3 months. The study is conducted within a prospective colorectal cancer cohort using a randomized controlled design. During the study, participants will have blood samples taken and visits with their physicians before each chemotherapy cycle if assigned to treatment. Researchers will monitor disease-free survival, overall survival, and quality of life using questionnaires over several years. They will also assess the clearance of ctDNA after chemotherapy and study its presence at recurrence. The total follow-up includes up to 2 years for disease recurrence and up to 5 years for survival 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 evaluating the benefits and costs of routine follow-up appointments after total hip or knee replacement surgery, particularly focusing on the 1-year follow-up visit. Current guidelines recommend follow-ups with X-rays at 3 months, 1 year, and then every 5 years for knee or hip replacements. However, these frequent visits may require significant time and resources from patients, caregivers, and healthcare providers, and it is unclear if all scheduled visits are necessary. The HAKA trial aims to safely reduce these routine follow-ups and update clinical guidelines accordingly. The trial compares two approaches one group receives standard care with X-rays and clinical visits at 3 months and 1 year after surgery, while the other group has the same 3-month visit but only a 1-year visit if requested by the patient or healthcare provider. This randomized study is part of a larger research program including long-term follow-up and qualitative studies about patient and provider experiences. Participants receive care following these schedules and are monitored over time. Participants will complete questionnaires assessing physical function, pain, and quality of life before surgery and at several intervals up to 24 months after surgery. Researchers will track the number of clinical visits, X-rays, complications, additional surgeries, and related costs during this period. The study monitors outcomes to evaluate whether reducing routine follow-ups is safe and cost-effective. Overall participation lasts about two years, with regular assessments to guide care decisions.

Researchers are studying women with node-positive breast cancer who receive neoadjuvant systemic therapy NST, which includes chemotherapy with or without immunotherapy. The study aims to understand the safety and quality of life effects of using less invasive methods compared to more invasive axillary staging and treatment after NST. This is important because patients whose lymph nodes show no remaining cancer after NST may not benefit from extensive lymph node removal, but more evidence is needed about the safety and impact of less invasive approaches. This multicenter observational study collects detailed information on patients treated with NST for node-positive breast cancer. It gathers data about the cancer, staging methods before and after NST, and treatment details from medical records. Patients complete questionnaires about their quality of life at diagnosis, and then 1 and 5 years later. The study database is maintained by the Netherlands Cancer Registry and aims to inform future treatment guidelines. Participants provide information through patient-reported outcome measures and undergo regular clinical follow-up to monitor disease-free survival, breast cancer-specific survival, overall survival, and rates of cancer recurrence in the lymph nodes over five years. Quality of life is assessed using several validated tools at baseline and during follow-up. The study results will help balance treatment decisions between less and more invasive options and support shared decision making for women with this breast cancer type.

This research aims to improve prediction of surgery success for patients with borderline resectable BR and locally advanced pancreatic ductal adenocarcinoma LAPDA undergoing neoadjuvant chemotherapy with FOLFIRINOX. The study focuses on combining diffusion-weighted magnetic resonance imaging DW-MRI, radiomics, and multi-omics profiling of blood samples to better identify which tumors can be surgically removed. This approach seeks to reduce unnecessary surgeries and improve treatment decisions due to challenges in current imaging and tumor marker accuracy. Participants will receive standard care including CT scans, CA 19-9 blood tests, and FOLFIRINOX chemotherapy. Additional DW-MRI scans and blood samples for genetic and molecular analysis will be collected before and after chemotherapy. If imaging shows no tumor progression and CA 19-9 levels decrease, surgical exploration may be pursued. Blood samples will also be taken during surgery and at the first follow-up visit to further evaluate tumor characteristics and treatment response. Throughout the study, participants will undergo imaging tests, blood draws, and questionnaires about health status and quality of life. Researchers will analyze data to predict surgical resectability, assess complications, and evaluate disease-free and overall survival over several years. This comprehensive monitoring aims to enhance personalized treatment plans while minimizing risks from unnecessary procedures.

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 safety and effectiveness of the Supraflex Family sirolimus-eluting coronary stent system in patients needing stent implantation for coronary artery disease. This observational registry study focuses on a real-world patient population to understand how this stent performs outside of tightly controlled clinical trials. The study is sponsored by Sahajanand Medical Technologies Limited and aims to gather important safety and efficacy data with the new stent design. The Supraflex stent features a biodegradable polymer coating on a cobalt-chromium platform, designed to improve long-term safety and flexibility compared to earlier stainless steel stents. Patients receive at least one Supraflex Family sirolimus-eluting stent as part of their usual clinical care. The study observes patients after their stent implantation without altering their treatment, focusing on real-world use. Follow-up is planned to track outcomes over time. Participants will be monitored for outcomes including target lesion failure, major cardiac events, stent thrombosis, deaths, heart attacks, and repeat procedures over a 12-month period. Researchers will collect medical information and assess patients through scheduled follow-up visits to gather this data. The study does not involve extra treatments but tracks patient progress to better understand the stents performance in everyday clinical use.