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http://hdl.handle.net/1942/31835
Title: | Outcome measures in multimodal rectal cancer trials | Authors: | Fokas, Emmanouil Glynne-Jones, Robert Appelt, Ane Beets-Tan, Regina Beets, Geerard Haustermans, Karin Marijnen, Corrie Minsky, Bruce D. Ludmir, Ethan Quirke, Phil Sebag-Montefiore, David Garcia-Aguilar, Julio Gambacorta, Maria Antonietta Valentini, Vincenzo BUYSE, Marc Rodel, Claus |
Issue Date: | 2020 | Publisher: | ELSEVIER SCIENCE INC | Source: | LANCET ONCOLOGY, 21 (5) , p. E252 -E264 | Abstract: | 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. | Notes: | Fokas, E (corresponding author), Goethe Univ Frankfurt, Dept Radiotherapy & Oncol, D-60590 Frankfurt, Germany. emmanouil.fokas@kgu.de |
Other: | Fokas, E (corresponding author), Goethe Univ Frankfurt, Dept Radiotherapy & Oncol, D-60590 Frankfurt, Germany. emmanouil.fokas@kgu.de | Keywords: | 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 | Document URI: | http://hdl.handle.net/1942/31835 | Link to publication/dataset: | https://www.thelancet.com/pdfs/journals/lanonc/PIIS1470-2045(20)30024-3.pdf | ISSN: | 1470-2045 | e-ISSN: | 1474-5488 | DOI: | 10.1016/S1470-2045(20)30024-3 | ISI #: | WOS:000540084200017 | Rights: | Elsevier Inc. except certain content provided by third parties. | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2021 |
Appears in Collections: | Research publications |
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