Neoadjuvant chemotherapy for obstructive colon cancer derived by a stoma: Study protocol of the FRENCH-01 randomized phase III trial (COnCERTO Trial)

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.

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Journal
Digestive and Liver Disease
Published
2026-04-01
DOI
https://doi.org/10.1016/j.dld.2026.03.006
Primary Topic
Colorectal Cancer Surgical Treatments
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article

Neoadjuvant chemotherapy for obstructive colon cancer derived by a stoma: Study protocol of the FRENCH-01 randomized phase III trial (COnCERTO Trial)

Clarisse Eveno, Émilie Duchalais, Karina Vychnevskaia, Bogdan Badic et al.
Digestive and Liver Disease
Colorectal Cancer Surgical Treatments
article

Neoadjuvant chemotherapy for obstructive colon cancer derived by a stoma: Study protocol of the FRENCH-01 randomized phase III trial (COnCERTO Trial)

Clarisse Eveno, Émilie Duchalais, Karina Vychnevskaia, Bogdan Badic, Vahan Képénékian, Bertrand Trilling, A. Alves, S. Noullet, Morgane Bouquot, Kocéila Amroun, Valérie Bridoux, Nathan Moreno-Lopez, Zaher Lakkis, Rémi Darrius, M. Hitier, Jean‐Pierre Duffas, Johanna Zemour, Laura Beyer, F. Mauvais, Benjamin Fernandez, Ugo Marchese, Jérémie H. Lefevre, Olivier Dubreuil, Rodolfo Romero, Léon Maggiori, Mehdi Ouaissi, Gilles Manceau, Stéphane Benoist, Yannick Tourreau, Florence Jeune, Diane Mege, Hélène Flesch, Charles Sabbagh, Benoist Romain, Christophe Tresallet, Mehdi Karoui, Adeline Germain, Philippe Zerbib
article en

Abstract

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.

Digestive and Liver Disease
Université de Tours (FR), Délégation Paris 5 (FR), Université Fédérale de Toulouse Midi-Pyrénées (FR), Université Paris Cité (FR), Université Paris-Saclay (FR), Centre Hospitalier Universitaire de Grenoble (FR), Saint Louis University Hospital (US), Université de Poitiers (FR), Sorbonne Université (FR), Centre Hospitalier Universitaire de La Réunion (RE), Centre Hospitalier Universitaire de Besançon (FR), Hôpital Charles-Nicolle (FR), Université Sorbonne Paris Nord (FR), Sorbonne Paris Cité (FR), Hopitaux Civils de Colmar (FR), Centre Hospitalier Universitaire de Tours (FR), Centre Hospitalier Universitaire Amiens-Picardie (FR), Hôpital Bretonneau (FR), Centre Hospitalier Régional et Universitaire de Nancy (FR), Hôpital Européen Georges-Pompidou (FR), Centre Hospitalier De Pau (FR), Centre Hospitalier Universitaire de Reims (FR), Groupe Hospitalier Mutualiste de Grenoble (FR), Centre Hospitalier de Beauvais (FR), Hôpital Lyon Sud (FR), Groupe Hospitalier Diaconesses Croix Saint-Simon (FR), Hôpital Nord (FR), École Nationale Supérieure d'Architecture de Versailles (FR), Hôpital Cardiologique du Haut-Lévêque (FR), Pitié-Salpêtrière Hospital (FR), Institut de Recherche en Santé Digestive (FR), Hôpital Avicenne (FR), Centre Hospitalier Régional Universitaire de Brest (FR), Hôpital Ambroise-Paré (FR), Centre de Recherche Saint-Antoine (FR), Peuplements végétaux et bioagresseurs en milieu tropical (RE), Maison des Sciences sociales et des Humanités de Dijon (FR), Centre Hospitalier Saint-Denis (FR), Centre Hospitalier de Versailles (FR), Hôpital de la Timone (FR), Bicêtre Hospital (FR), Hôpital Civil, Strasbourg (FR), Université de Strasbourg (FR), Université Grenoble Alpes (FR), Université de Reims Champagne-Ardenne (FR), Nantes Université (FR), Université de Caen Normandie (FR)
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Colorectal Cancer Surgical Treatments
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