Primary endpoint
mrTumor, TRG
DISEASE, EVENT
Decision to Watch and Wait due to clinical complete response achieved at 18 weeks from last date of radiation using clinical (Digital rectal examination—DRE), endoscopic and radiological criteria (mrTumor Regresion Grade—TRG grade) or near-complete clinical response (no progressive disease clinically, endoscopically or radiologically).Definition of cCR available below and at the discretion of the attending surgeon.Definition of radiological complete response as described below (centralized).Patients will be counted as event if at 18 weeks the decision is to interrupt Watch and Wait and proceed to surgery (any kind) because of overt incomplete clinical response. In order to standardize assessment of response and reduce inter-observer variability, the decision to continue on Watch and Wait (or not) will be at the discretion of the central committee during central revision of studies.