452O - Results of a prospective randomised control 6 vs 12 trial: Is greater tumour downstaging observed on post treatment MRI if surgery is delayed to 12...

Date 09 October 2016
Event ESMO 2016 Congress
Session Gastrointestinal tumours, colorectal 1
Topics Colon and Rectal Cancer
Staging procedures (clinical staging)
Surgical oncology
Basic Principles in the Management and Treatment (of cancer)
Radiation oncology
Presenter Jemma Bhoday
Citation Annals of Oncology (2016) 27 (6): 149-206. 10.1093/annonc/mdw370
Authors J. Evans1, J. Bhoday2, B. Sizer3, P. Tekkis4, R. Swift5, R. Perez6, D. Tait1, G. Brown1
  • 1Colorectal Surgery, Royal Marsden Hospital NHS Foundation Trust, SM2 5PT - London/GB
  • 2Colorectal Surgery And Radiology, Royal Marsden Hospital NHS Foundation Trust, SM2 5PT - London/GB
  • 3Colorectal Surgery, Colchester Hospital University Essex County Hospital, CO4 5JL - Colchester/GB
  • 4Colorectal Surgery, Royal Marsden Hospital NHS Foundation Trust, SW3 6JJ - London/GB
  • 5Colorectal Surgery, Croydon University Hospital, CR7 7YE - London/GB
  • 6Colorectal Surgery, Ludwig Institute for Cancer research, 04001-005 - São Paulo/BR



The optimum interval between CRT and surgery for locally advanced rectal cancer remains controversial. If greater downstaging occurs with a longer interval to surgery, this may impact on rates of sphincter preservation and survival. A prospective, randomised, multicentre trial was undertaken to determine whether greater rectal cancer downstaging and regression occurs when surgery is delayed to 12 compared to 6-weeks.


The primary endpoint was difference in proportion of patients in each arm downstaged according to MRI T-stage - defined as any reduction in T-stage/sub-stage. A sample size of 218 patients was required. Secondary endpoints included pCR and mrTRG 1-2 rates.


A total of 237 patients were randomised: 122 (51%) into the 6-week and 115 (49%) to the 12-week arm. A significantly greater proportion downstaged in the 12-week (58%) compared with 43% in the 6-week arm (p = 0.019). The pCR rate was 9% in the 6-week versus 20% for the 12-week arm (p 


Waiting 12-weeks after CRT results in significantly more mrT downstaging, pCR and improved mrTRG. Since mrTRG is a validated predictor of disease free survival, undertaking surgery before maximal regression may be disadvantageous.

Clinical trial identification

Legal entity responsible for the study



Biomedical Research Centre


All authors have declared no conflicts of interest.