Valérie Bridoux, Benjamin Fernandez, Charles Sabbagh, M. Hitier, Vahan Képénékian, Kocéila Amroun, Morgane Bouquot, Zaher Lakkis, Mehdi Ouaissi, Rémi Darrius, Olivier Dubreuil, Émilie Duchalais, Nathan Moreno-Lopez, Bertrand Trilling, Johanna Zemour, Laura Beyer, A. Alves, F. Mauvais, S. Noullet, Rodolfo Romero, Christophe Tresallet, Bogdan Badic, Stéphane Benoist, Clarisse Eveno, Florence Jeune, Adeline Germain, Jean‐Pierre Duffas, Jérémie H. Lefevre, Léon Maggiori, Gilles Manceau, Ugo Marchese, Diane Mege, Hélène Flesch, Benoist Romain, Yannick Tourreau, Philippe Zerbib, Karina Vychnevskaia, Mehdi Karoui
BACKGROUND: Obstructive colon cancer (OCC) is at poor prognosis, and the high morbidity of emergency resection frequently delays or precludes adjuvant chemotherapy. A strategy with first step diverting stoma - neoadjuvant chemotherapy (NAC) - colectomy in non-metastatic OCC may represent an alternative to the conventional strategy of stoma followed by colectomy. METHOD: COnCERTO is a multicenter, open-label, randomized (1:1), phase III trial evaluating NAC followed by colectomy ± adjuvant chemotherapy versus standard-of-care colectomy ± adjuvant chemotherapy in adults with resectable non-metastatic MSS OCC first treated by a defunctionning stoma. Two hundred and thirty-two will be randomized across 37 French centers. The primary endpoint is the rate of complete curative therapeutic sequence combining the resection of the primary and the administration of scheduled NAC and/ or adjuvant chemotherapy. Secondary endpoints include the tolerance and compliance of NAC and/ or adjuvant chemotherapy (SRAE ≥ grade 3, CTCAE v5.0), quality and completeness of the surgical excision, 90 days postoperative morbidity, health-related quality of life, OS and DFS at 3 years and survival without stoma at 3 years. Randomization started in May 2024. DISCUSSION: COnCERTO will determine whether a NAC approach can be pursued safely and effectively in localized OCC and translate into a better cancer control and quality of life improvement. REGISTRATION NUMBER: ClinicalTrials.gov NCT06107920.