Bmc Cancer
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Upfront cytoreductive surgery with HIPEC (CRS-HIPEC) is the standard treatment for isolated resectable colorectal peritoneal metastases (PM) in the Netherlands. This study investigates whether addition of perioperative systemic therapy to CRS-HIPEC improves oncological outcomes. ⋯ This is the first randomised study that prospectively compares oncological outcomes of perioperative systemic therapy and CRS-HIPEC with upfront CRS-HIPEC alone for isolated resectable colorectal PM.
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Randomized Controlled Trial Multicenter Study
Enzalutamide versus flutamide for castration-resistant prostate cancer after combined androgen blockade therapy with bicalutamide: study protocol for a multicenter randomized phase II trial (the OCUU-CRPC study).
Enzalutamide is an oral androgen receptor targeted agent that has been shown to improve survival in PREVAIL trials and has been approved for patients with chemo-naïve metastatic castration-resistant prostate cancer (CRPC). Meanwhile, flutamide is a non-steroidal oral anti-androgen that was commonly used before the approval of bicalutamide. The objective of the OCUU-CRPC study is to compare the efficacy and safety between second-line hormonal therapy of enzalutamide and flutamide as alternative anti-androgen therapy (AAT) after combined androgen blockade (CAB) therapy that included bicalutamide in patients with CRPC. ⋯ In the OCUU-CRPC study, we compare the efficacy and safety of enzalutamide or alternative AAT with flutamide in participants with CRPC who were previously treated with a CAB therapy with bicalutamide. The expected results of this study will be that enzalutamide is superior to flutamide in terms of PSA response. A longer time to disease progression with enzalutamide over flutamide may translate to better overall survival. However, flutamide may be more accessible for patients owing to its lower cost than enzalutamide.
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Randomized Controlled Trial
Rationale and design of extended cancer education for longer term survivors (EXCELS): a randomized control trial of 'high touch' vs. 'high tech' cancer survivorship self-management tools in primary care.
Breast, colorectal, and prostate cancer survivors are at increased risk for late and long-term effects post-treatment. The post-treatment phase of care is often poorly coordinated and survivors navigate follow-up care with minimal information or guidance from their healthcare team. This manuscript describes the Extended Cancer Education for Longer-term Survivors (EXCELS) in Primary Care protocol. EXCELS is a randomized controlled trial to test the efficacy of patient-level self-management educational strategies on adherence to preventative health service use and cancer survivorship follow-up guidelines. ⋯ The EXCELS trial is the first to test cancer survivorship educational self-management interventions for cancer survivors in a primary care context. Findings from this trial will inform successful implementation and engagement strategies for longer-term, post-treatment cancer survivors managed in primary care settings.