New hope for rectal cancer: extra chemo may save the rectum

NCT ID NCT02514278

Completed Disease control Sponsor: University Hospital, Bordeaux Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tested whether adding two months of Folfirinox chemotherapy before standard radiation and chemo could help more patients with early-stage rectal cancer avoid major surgery. 218 adults with small, low-lying tumors were enrolled. The goal was to see if more patients could keep their rectum and have no stoma one year after treatment.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Folfirinox chemotherapy (oxaliplatin, irinotecan, folinic acid, 5FU) and capecitabine
What this could lead to: If it works, this could allow more people with rectal cancer to keep their rectum and avoid a permanent stoma, improving quality of life.
What could go wrong: This is a completed phase 3 trial, but results may not apply to all patients. Adding chemotherapy also increases side effects like nerve damage and digestive issues.

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

RECTAL CANCER

Contacts and locations

Locations

Département de chirurgie digestive, Institut Gustave Roussy

Villejuif, France
GH Paris Saint Joseph

Paris, France
Service d'Oncologie et Radiothérapie, Centre Azuréen de Cancérologie

Mougins, France
Service de Chirurgie Digestive et Oncologique, Hôpital Bicêtre - APHP

Paris, France
Service de Chirurgie Digestive, CHU Amiens Picardie

Amiens, France
Service de Chirurgie Digestive, CHU Carémeau - Nîmes

Nîmes, France
Service de Chirurgie Digestive, CHU Estaing - CHRU Clermont Ferrand

Clermont-Ferrand, France
Service de Chirurgie Digestive, CHU de Besançon

Besançon, France
Service de Chirurgie Digestive, CHU de la Timone - Marseille

Marseille, France
Service de Chirurgie Digestive, Centre Georges François Leclerc - Dijon

Dijon, France
Service de Chirurgie Digestive, Centre Léon Bérard - Lyon

Lyon, France
Service de Chirurgie Digestive, Centre Oscar Lambret - Lille

Lille, France
Service de Chirurgie Digestive, Hôpital Albert Michallon - CHU de Grenoble

La Tronche, France
Service de Chirurgie Digestive, Hôpital Beaujon - APHP

Clichy, France
Service de Chirurgie Digestive, Hôpital Charles Nicolle - CHU de Rouen

Rouen, France
Service de Chirurgie Digestive, Hôpital Haut-Lévêque - CHU de Bordeaux

Bordeaux, France
Service de Chirurgie Digestive, Hôpital Lyon Sud - CHU Lyon

Lyon, France
Service de Chirurgie Digestive, Hôpital Pontchaillou - CHU Rennes

Rennes, France
Service de Chirurgie Digestive, Hôpital Purpan - CHU de Toulouse

Toulouse, France
Service de Chirurgie Digestive, Hôpital Saint-Antoine - APHP

Paris, France
Service de Chirurgie Digestive, Hôpital Saint-Louis - APHP Paris

Paris, France
Service de Chirurgie Digestive, Hôpital les Diaconnesses

Paris, France
Service de Chirurgie Digestive, Hôtel Dieu - CHU de Nantes

Nantes, France
Service de Chirurgie Digestive, Institut Bergonié

Bordeaux, France
Service de Chirurgie Digestive, Institut Paoli Calmette - Marseille

Marseille, France
Service de Chirurgie Digestive, Institut du Cancer de Montpellier

Montpellier, France
Service de Chirurgie Digestive,Institut de Cancérologie de Lorraine

Nancy, France
Service de Chirurgie Digestives, Hôpital Européen de Marseille

Marseille, France
Service de chirurgie digestive, CHRU de Nancy -Hôpital de Brabois

Vandœuvre-lès-Nancy, France

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