Optimisation of Response for Organ Preservation in Rectal Cancer : Neoadjuvant Chemotherapy and Radiochemotherapy vs. Radiochemotherapy

PHASE3CompletedINTERVENTIONAL
Enrollment

218

Participants

Timeline

Start Date

January 28, 2016

Primary Completion Date

June 9, 2022

Study Completion Date

June 30, 2024

Conditions
Rectal Cancer
Interventions
DRUG

Neoadjuvant chemotherapy Folfirinox, 4 cycles

"* oxaliplatin: 85 mg/m2~* irinotecan: 180 mg/m²~* folinic acid: 400 mg/m2 (DL form) or 200 mg/m2 (L form)~* 5FU: 2400 mg/m2"

RADIATION

50 Gy, 2 Gy/session; 25 fractions

Radiochemotherapy 5 weeks

PROCEDURE

Local excision in good responders

"If local excision:~* Surveillance if ypT0-1 or ypT2Nx/cN0 (no lymph node at baseline imaging)~* Complementary rectal excision if ypT2Nx/cN1, ypT3 or R1."

PROCEDURE

Rectal excision in bad responders

DRUG

Capecitabine

1600 mg/m2 daily 5 days/7

Trial Locations (29)

Unknown

Service de Chirurgie Digestive, CHU Amiens Picardie, Amiens

Service de Chirurgie Digestive, CHU de Besançon, Besançon

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

Service de Chirurgie Digestive, Institut Bergonié, Bordeaux

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

Service de Chirurgie Digestive, Hôpital Beaujon - APHP, Clichy

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

Service de Chirurgie Digestive, Hôpital Albert Michallon - CHU de Grenoble, La Tronche

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

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

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

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

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

Service de Chirurgie Digestives, Hôpital Européen de Marseille, Marseille

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

Service d'Oncologie et Radiothérapie, Centre Azuréen de Cancérologie, Mougins

Service de Chirurgie Digestive,Institut de Cancérologie de Lorraine, Nancy

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

Service de Chirurgie Digestive, CHU Carémeau - Nîmes, Nîmes

GH Paris Saint Joseph, Paris

Service de Chirurgie Digestive et Oncologique, Hôpital Bicêtre - APHP, Paris

Service de Chirurgie Digestive, Hôpital les Diaconnesses, Paris

Service de Chirurgie Digestive, Hôpital Saint-Antoine - APHP, Paris

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

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

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

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

Service de chirurgie digestive, CHRU de Nancy -Hôpital de Brabois, Vandœuvre-lès-Nancy

Département de chirurgie digestive, Institut Gustave Roussy, Villejuif

All Listed Sponsors
lead

University Hospital, Bordeaux

OTHER

NCT02514278 - Optimisation of Response for Organ Preservation in Rectal Cancer : Neoadjuvant Chemotherapy and Radiochemotherapy vs. Radiochemotherapy | Biotech Hunter | Biotech Hunter