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Optimisation of Response for Organ Preservation in Rectal Cancer : Neoadjuvant Chemotherapy and Radiochemotherapy vs. Radiochemotherapy
Sponsor: University Hospital, Bordeaux
Summary
Standard treatment of rectal cancer is rectal excision with neoadjuvant radiochemotherapy. A new concept suggests organ preservation as an alternative to rectal excision in good responders after neoadjuvant radiochemotherapy to decrease surgical morbidity and increase quality of life. The rational is the fact that 15% of patients have sterilized tumours after radiochemotherapy for T3T4 rectal cancer. The French GRECCAR 2 trial is the first phase III trial investigating this strategy: patients with T2T3 low rectal carcinomas (size ≤4 cm) received 50 Gy with capecitabine and good clinical responders (≤2 cm) were randomized between local and rectal excision. The main findings were: the rate of complete pathologic response was higher after radiochemotherapy for small T2T3 than for T3T4 tumours (40% vs 15% ypT0) and good pathologic responders (ypT0-1) were associated with zero positive mesorectal nodes. The objective of the new trial is to increase the proportion of patients treated with organ preservation by optimizing tumour response. As compared to Folfiri, tritherapy Folfirinox has been shown to enhance the response rate. In patients with colorectal metastases, response rate and R0 resection were twice higher, resulting in improved survival. Folfirinox also increases response and chance of R0 resection rates in initially unresectable colorectal metastases, compared to standard or intensified bi-chemotherapy regimens. Adding two months of neoadjuvant chemotherapy (Folfirinox) before radiochemotherapy, the investigators expect to increase chance of organ preservation rate, as compared to radiochemotherapy alone.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
218
Start Date
2016-01-28
Completion Date
2024-06-30
Last Updated
2026-05-14
Healthy Volunteers
No
Conditions
Interventions
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
50 Gy, 2 Gy/session; 25 fractions
Radiochemotherapy 5 weeks
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.
Rectal excision in bad responders
Capecitabine
1600 mg/m2 daily 5 days/7
Locations (29)
Service de Chirurgie Digestive, CHU Amiens Picardie
Amiens, France
Service de Chirurgie Digestive, CHU de Besançon
Besançon, France
Service de Chirurgie Digestive, Hôpital Haut-Lévêque - CHU de Bordeaux
Bordeaux, France
Service de Chirurgie Digestive, Institut Bergonié
Bordeaux, France
Service de Chirurgie Digestive, CHU Estaing - CHRU Clermont Ferrand
Clermont-Ferrand, France
Service de Chirurgie Digestive, Hôpital Beaujon - APHP
Clichy, France
Service de Chirurgie Digestive, Centre Georges François Leclerc - Dijon
Dijon, France
Service de Chirurgie Digestive, Hôpital Albert Michallon - CHU de Grenoble
La Tronche, France
Service de Chirurgie Digestive, Centre Oscar Lambret - Lille
Lille, France
Service de Chirurgie Digestive, Centre Léon Bérard - Lyon
Lyon, France
Service de Chirurgie Digestive, Hôpital Lyon Sud - CHU Lyon
Lyon, France
Service de Chirurgie Digestive, CHU de la Timone - Marseille
Marseille, France
Service de Chirurgie Digestive, Institut Paoli Calmette - Marseille
Marseille, France
Service de Chirurgie Digestives, Hôpital Européen de Marseille
Marseille, France
Service de Chirurgie Digestive, Institut du Cancer de Montpellier
Montpellier, France
Service d'Oncologie et Radiothérapie, Centre Azuréen de Cancérologie
Mougins, France
Service de Chirurgie Digestive,Institut de Cancérologie de Lorraine
Nancy, France
Service de Chirurgie Digestive, Hôtel Dieu - CHU de Nantes
Nantes, France
Service de Chirurgie Digestive, CHU Carémeau - Nîmes
Nîmes, France
GH Paris Saint Joseph
Paris, France
Service de Chirurgie Digestive et Oncologique, Hôpital Bicêtre - APHP
Paris, France
Service de Chirurgie Digestive, Hôpital les Diaconnesses
Paris, 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 Pontchaillou - CHU Rennes
Rennes, France
Service de Chirurgie Digestive, Hôpital Charles Nicolle - CHU de Rouen
Rouen, France
Service de Chirurgie Digestive, Hôpital Purpan - CHU de Toulouse
Toulouse, France
Service de chirurgie digestive, CHRU de Nancy -Hôpital de Brabois
Vandœuvre-lès-Nancy, France
Département de chirurgie digestive, Institut Gustave Roussy
Villejuif, France