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Outcome measures in multimodal rectal cancer trials

Tijdschriftbijdrage - Review Artikel

There is a large variability regarding the definition and choice of primary endpoints in phase 2 and phase 3 multimodal rectal cancer trials, resulting in inconsistency and difficulty of data interpretation. Also, surrogate properties of early and intermediate endpoints have not been systematically assessed. We provide a comprehensive review of clinical and surrogate endpoints used in trials for non-metastatic rectal cancer. The applicability, advantages, and disadvantages of these endpoints are summarised, with recommendations on clinical endpoints for the different phase trials, including limited surgery or non-operative management for organ preservation. We discuss how early and intermediate endpoints, including patient-reported outcomes and involvement of patients in decision making, can be used to guide trial design and facilitate consistency in reporting trial results in rectal cancer.
Tijdschrift: Lancet Oncology
ISSN: 1470-2045
Issue: 5
Volume: 21
Pagina's: E252 - E264
Jaar van publicatie:2020
Trefwoorden:Total Mesorectal Excision, Surrogate End-Points, Randomized Phase-Iii, Short-Course Radiotherapy, Disease-Free Survival, Quality-Of-Life, Preoperative Radiotherapy, Follow-Up, Postoperative Chemoradiotherapy, Local Recurrence, Hematologie en oncologie