Beverwijk

This trial studies men with low-volume, hormone-sensitive metastatic prostate cancer to evaluate if a shorter treatment duration with androgen receptor pathway inhibitors (ARPIs) like Apalutamide or Enzalutamide is as effective as continuous therapy. The purpose is to see if stopping ARPI treatment after 12 months, with the option to restart if the cancer progresses, can reduce side effects and costs without worsening outcomes. This is a Phase 3 randomized nationwide study focusing on patients with low-volume metastatic disease confirmed by imaging and clinical assessment. Participants will receive androgen deprivation therapy (ADT) combined with either continuous ARPI treatment or ARPI treatment stopped at 12 months. Those who stop ARPI after 12 months may restart treatment if their PSA levels rise, confirmed by a second test at least 4 weeks later. The study compares these two approaches to understand if shorter ARPI use is non-inferior to continuous use, aiming to reduce treatment toxicity while maintaining disease control. Participants will be followed for up to 6 years, with clinical progression-free survival as the main outcome. Researchers will monitor time from study inclusion to disease progression or treatment end. Patients will undergo regular assessments including PSA testing and clinical evaluations to track disease status. Safety and treatment effects will be closely observed throughout the study period, which includes up to 5 years of active follow-up after randomization.

Researchers are investigating how psychological factors, specifically neuroticism, affect recovery after surgery for proximal humerus fractures. This study aims to determine if adding psychological guidance through focused cognitive behavioral therapy can improve functional outcomes for patients who have high levels of neuroticism. The trial also examines secondary effects such as range of motion, pain levels, medication use, return to work, anxiety, depression, and overall health following surgery. Participants will be randomly assigned to two groups. The control group receives standard postoperative care including multiple outpatient visits and physical therapy. The intervention group receives the same care plus eight sessions of psychological coaching over six months, beginning two to three weeks after surgery. These sessions, led by licensed psychologists, include education and exercises on relaxation, pain coping, changing unhelpful beliefs, and improving treatment adherence. The initial sessions are in person, with later ones optionally via videocall. Throughout the study, participants will have follow-up visits at 3, 6, and 12 months post-surgery to assess their shoulder function using the Constant Shoulder Score. Additional evaluations include questionnaires on pain, psychological status, and daily activities. Safety is monitored continuously, and serious adverse events will be reported promptly. Data will be analyzed to compare outcomes between groups, aiming to understand the benefit of psychological coaching in this patient population.

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 whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

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 evaluating treatments for men with high-risk non-metastatic prostate cancer to compare robot-assisted radical prostatectomy (RARP) and external beam radiotherapy (EBRT), which may be combined with androgen deprivation therapy (ADT). This study aims to understand which treatment better supports health-related quality of life, functional outcomes, cost-effectiveness, progression-free survival, and distant metastasis-free survival. Currently, there is no clear consensus on the optimal treatment, leading to varied use of these options across hospitals. The study examines these two common treatment methods for high-risk prostate cancer. Both RARP and EBRT (with or without ADT) have side effects that can affect patients' quality of life. By collecting detailed data on outcomes and costs, the study seeks to provide evidence to guide treatment choices and improve shared decision-making between patients and healthcare providers. Participants will be followed for at least three years after starting treatment. During this time, researchers will assess functional outcomes and health-related quality of life. These long-term measures will help determine how each treatment impacts patients over time, supporting better personalized care and informing national guidelines.

Researchers are studying breast cancer patients who have cancer that has spread to lymph nodes and are treated with neoadjuvant systemic therapy (NST), which includes chemotherapy and sometimes immunotherapy. The study focuses on how to best check and treat the lymph nodes after NST, comparing less invasive methods to the traditional axillary lymph node dissection (ALND). The goal is to see if less invasive techniques can offer similar cancer control and quality of life benefits. This multicenter observational study includes patients with positive lymph nodes who receive NST followed by breast and axillary treatment. Data on patient characteristics, tumor details, staging before and after NST, and treatments will be collected into a national database. Patients will complete quality of life questionnaires at diagnosis, and then 1 and 5 years later to understand the impact of different axillary treatment strategies. Participants will be followed for 5 years to evaluate disease-free survival, breast cancer-specific survival, overall survival, and rates of cancer returning in the lymph nodes. Quality of life will be measured using multiple questionnaires over time. The study aims to provide evidence to improve national guidelines and support shared decision-making about axillary treatment options for node positive breast cancer patients.

Researchers are evaluating the safety and effectiveness of denovoSkin14, an engineered skin graft made from a patient's own cells, in treating severe burns involving deep partial and full-thickness wounds. This phase III clinical trial includes adults and adolescents aged 12 years and older who have suffered burns covering at least 20% of their total body surface area. The study compares denovoSkin14 to the standard treatment of split-thickness skin grafts to see if it can improve wound closure and reduce scarring. Participants will receive two types of treatments on different areas of their burn wounds: the experimental denovoSkin14 graft and the control split-thickness skin graft. The denovoSkin14 is a biological skin substitute composed of autologous fibroblasts and keratinocytes arranged in a bilayer collagen matrix. The study involves transplanting both graft types to the respective burn areas, allowing direct comparison within the same patient. This randomized controlled design aims to confirm the graft's functional benefits over standard care. During the study, participants will be monitored for wound healing and scar quality over a period of six months after grafting. Researchers will assess whether wounds close successfully and evaluate scar appearance using a validated scar assessment scale (POSAS v2.0). Safety and adverse events will also be tracked throughout the trial. The total participation time includes screening, treatment, and follow-up evaluations to thoroughly evaluate the outcomes of both graft types.

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.