A rectal cancer feasibility study with an embedded phase III trial design assessing magnetic resonance tumour regression grade (mrTRG) as a novel biomarker to stratify management by good and poor response to chemoradiotherapy (TRIGGER): Study protocol for a randomised controlled trial

• Main Authors: Battersby, N.J, Dattani, M, Rao, S, Cunningham, D, Tait, D, Adams, R, Moran, B.J, Khakoo, S, Tekkis, P, Rasheed, S, Mirnezami, A, Quirke, P, West, N.P, Nagtegaal, I, Chong, I, Sadanandam, A, Valeri, N, Thomas, K, Frost, M, Brown, G
• Other Authors: SURGERY
• Format: Article
• Published: 2020
• Subjects: capecitabine; fluorouracil; folinic acid; oxaliplatin; advanced cancer; Article; cancer grading; cancer localization; cancer survival; cell density; chemoradiotherapy; controlled study; drug toxicity; feasibility study; health economics; human; human cell; human tissue; intervention study; magnetic resonance tumor regression grade; morbidity; multicenter study; multiple cycle treatment; nuclear magnetic resonance; open study; patient safety; phase 3 clinical trial; population research; prospective study; quality of life; randomized controlled trial; rectum cancer; rectum carcinoma; reproducibility; treatment response; tumor growth; tumor regression; unspecified side effect; adenocarcinoma; adjuvant chemoradiotherapy; clinical protocol; clinical trial; colostomy; cost benefit analysis; diagnostic imaging; disease exacerbation; disease free survival; economics; health care cost; intention to treat analysis; methodology; mortality; neoadjuvant therapy; nuclear magnetic resonance imaging; pathology; predictive value; rectum tumor; secondary; time factor; treatment outcome; tumor recurrence; Adenocarcinoma; Chemoradiotherapy, Adjuvant; Clinical Protocols; Colostomy; Cost-Benefit Analysis; Disease Progression; Disease-Free Survival; Feasibility Studies; Health Care Costs; Humans; Intention to Treat Analysis; Magnetic Resonance Imaging; Neoadjuvant Therapy; Neoplasm Grading; Neoplasm Recurrence, Local; Predictive Value of Tests; Quality of Life; Rectal Neoplasms; Research Design; Time Factors; Treatment Outcome
• Online Access: https://scholarbank.nus.edu.sg/handle/10635/179461
• Institution: National University of Singapore

10.1186/s13063-017-2085-2