GRECCAR6: A multicentric randomized controlled trial on the impact of lengthening the interval between neoadjuvant radiochemotherapy and surgery on complete pathological response in rectal cancer (GRECCAR-6 trial): rationale and design

Trial Overview

Acronym	GRECCAR6
Number	NCT01648894
Protocol Link	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3848646/
Public Trial Registry Link	https://clinicaltrials.gov/ct2/show/NCT01648894?term=greccar6&rank=1
Published Results Link	http://ascopubs.org/doi/abs/10.1200/JCO.2016.67.6049?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed
Status	Published
Category	Colorectal Cancer - Rectal Specific
Treatment Course	Neoadjuvant

Trial Description

GRECCAR6 was a phase III, multicenter, randomized, open-label, parallel-group controlled trial. Patients with cT3/T4 or Tx N+ tumors of the mid or lower rectum who had received RCT (45 to 50 Gy with fluorouracil or capecitabine) were included. Patients were randomly included in the 7-week or the 11-week (11w) group. Primary end point was the pCR rate defined as a ypT0N0 specimen.

Chief Investigator

Jeremie Lefevre
Prof.

Profile Link

Lead Centre

Hopital Saint-Antoine
184, rue du Faubourg Saint-Antoine
Paris
75012
France

Website

Collaboration and Funding

Collaborative Sites

Funding Sponsors

Additional Information

Full Research Summary

Objective:	A pathologic complete response (pCR; ypT0N0) of a rectal tumor after neoadjuvant radiochemotherapa (RCT) is associated with an excellent prognosis. Several retrospective studies have investigated the effect of increasing the delay after RCT.
Aim:	The aim of this study was to evaluate the effect of increasing the interval between the end of RCT and surgery on the pCR rate
Methods:	GRECCAR6 was a phase III, multicenter, randomized, open-label, parallel-group controlled trial. Patients with cT3/T4 or Tx N+ tumors of the mid or lower rectum who had received RCT (45 to 50 Gy with fluorouracil or capecitabine) were included. Patients were randomly included in the 7-week or the 11-week (11w) group. Primary end point was the pCR rate defined as a ypT0N0 specimen
Reason for International Trial:	A total of 265 patients from 24 centers were enrolled between October 2012 and February 2015