Outcome measures in multimodal rectal cancer trials
| Autor: | Karin Haustermans, Geerard L. Beets, David Sebag-Montefiore, Vincenzo Valentini, Marc Buyse, Bruce D. Minsky, Regina G. H. Beets-Tan, Julio Garcia-Aguilar, Phil Quirke, Ane L Appelt, Emmanouil Fokas, Rob Glynne-Jones, Ethan B. Ludmir, Claus Rödel, Maria Antonietta Gambacorta, Corrie A.M. Marijnen |
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| Rok vydání: | 2020 |
| Předmět: |
Research design
medicine.medical_specialty Time Factors Endpoint Determination Colorectal cancer MEDLINE LOCAL RECURRENCE 03 medical and health sciences 0302 clinical medicine QUALITY-OF-LIFE Clinical endpoint DISEASE-FREE SURVIVAL Humans Combined Modality Therapy Medicine SHORT-COURSE RADIOTHERAPY Patient Reported Outcome Measures Intensive care medicine PREOPERATIVE RADIOTHERAPY Settore MED/36 - DIAGNOSTICA PER IMMAGINI E RADIOTERAPIA 030304 developmental biology Clinical Trials as Topic 0303 health sciences Rectal Neoplasms Surrogate endpoint business.industry TOTAL MESORECTAL EXCISION Outcome measures RANDOMIZED PHASE-III medicine.disease Treatment Outcome Oncology Research Design 030220 oncology & carcinogenesis FOLLOW-UP business SURROGATE END-POINTS POSTOPERATIVE CHEMORADIOTHERAPY |
| Zdroj: | The Lancet Oncology. 21:e252-e264 |
| ISSN: | 1470-2045 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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