A randomized phase III trial of structured tumour response surveillance and shared decision-making for organ preservation in rectal cancer - PRODIGE 101-GRECCAR 20-EVAREC trial protocol.

Fiche publication

Date publication

janvier 2026

Journal

Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland

Auteurs

Membres identifiés du Cancéropôle Est :
Pr LEPAGE Côme

Tous les auteurs :
Noiret B, Vendrely V, Delattre A, Vavasseur A, Maillou-Martinaud H, Nougaret S, Jacques J, Haaser T, Lepage C, Denost Q

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/41536139

Résumé

Standard management with chemoradiotherapy (CRT) or total neoadjuvant therapy (TNT) followed by total mesorectal excision (TME) reduces local recurrence but often is associated with significant long-term functional impairment. Organ preservation (OP) has become a key therapeutic goal in rectal cancer to reduce surgery-related morbidity without compromising oncological outcomes. Three main OP strategies have been developed: Watch and Wait (W&W) strategy, Local Excision (LE) and Contact X-ray Brachytherapy (CXB), both applicable in patients showing a favourable tumour response after neoadjuvant therapy. The current challenge is defining the optimal timing and modalities for response assessment to accurately identify complete clinical response while balancing oncological control, functional outcomes and patient preferences. This trial evaluates whether a structured tumour response surveillance program combined with shared decision-making (SDM) can safely increase OP rates.