Interventional Recruiting Phase 3
NCT06107920 on ClinicalTrials.gov
Neoadjuvant Chemotherapy for Obstructive Colon cancER First Treated by cOlostomy
Official title: Neoadjuvant Chemotherapy for Obstructive Colon cancER First Treated by cOlostomy : A Randomized Phase III Trial - COnCERTO (French 01-18)
- Sponsor: Hôpital Charles-Nicolle (France)
- Enrollment: 232 (Estimated)
- Study start: 2024-05-07 (Actual)
- Primary completion: 2031-08-01 (Estimated)
- Study completion: 2031-08-01 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- Masking: None
- PrimaryPurpose: Treatment
Brief Summary
The aim of this study is to determine whether chemotherapy prior to tumor removal (neoadjuvant chemotherapy), in patients undergoing treatment for colon cancer in occlusion (CCO), would improve the rate of patients able to benefit from "optimal" treatment, i.e. complete treatment (including all neoadjuvant and adjuvant chemotherapy cures).
This new strategy, which would combine chemotherapy before surgery and possibly post-operatively (depending on tumor analysis), could improve the prognosis of occluded colon cancers by treating circulating micrometastases and/or inducing a reduction in tumor size, thereby increasing the rate of complete resection.
Conditions
- Colon Cancer
Intervention / Treatment
- Drug: Neoadjuvant chemotherapy
Primary Outcome Measures
-
the success of a full curative therapeutic
(36 months)
The treatment is complete if all the chemotherapy treatments (adjuvant for arm I / neoadjuvant and adjuvant for arm II) is done.
Countries
France
Locations and Investigators
- CHU Besancon, Besancon, France
-
Centre Hospitalier Universitaire De Bordeaux, Pessac Cedex, France
- BENJAMIN, FERNANDEZ
-
Centre Hospitalier Et Universitaire De Limoges, Limoges, France
- NIKI, CHRISTOU
-
Centre Hospitalier Universitaire Reims, Reims Cedex, France
- Koceila Lamine, AMROUN
-
Centre Hospitalier Simone Veil De Beauvais, Beauvais, France
- FRANCOIS, MAUVAIS
- Centre Hospitalier Regional De Marseille, Marseille, France
- Centre Hospitalier Regional Universitaire De Tours, Chambray Les Tours, France
- Assistance Publique Hopitaux De Paris, Paris Cedex 15, France
-
Centre Hospitalier Universitaire De Toulouse, Toulouse Cedex 9, France
- Jean Pierre, DUFFAS
- Assistance Publique Hopitaux De Paris, Bobigny Cedex, France
- Centre Hospitalier Universitaire De Nantes, Nantes, France
-
Centre Hospitalier De Pau, Pau Cedex, France
- Maryam, Hitier-Berthault
-
Centre Hospitalier Regional De Marseille, Marseille, France
- LAURA, BEYER
-
Centre Hospitalier General De St Denis, St Denis Cedex, France
- RODOLFO, ROMERO
-
Centre Hospitalier Universitaire De Dijon, Dijon, France
- NATHAN, MORENO
-
Centre Hospitalier De Colmar, Colmar Cedex, France
- REMI, DARRIUS
-
Hopitaux Universitaires Pitie Salpetriere, Paris Cedex 13, France
- SEVERINE, Noullet
- Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Cedex 9, France
-
Assistance Publique Hopitaux De Paris, Le Kremlin-Bicetre, France
- ANTOINE, BROUQUET
- Hopital Saint Louis, Paris, France
-
Hopital Ambroise Pare, Boulogne Billancourt, France
- FREDERIQUE, PESCHAUD
-
Hopital Huriez, Lille Cedex, France
- PHILIPPE, ZERBIB
-
Centre Hospitalier Universitaire De Caen Normandie, Caen Cedex 9, France
- ARNAUD, ALVES
-
Assistance Publique Hopitaux De Paris, Paris, France
- UGO, MARCHESE
-
Centre Hospitalier Regional Et Universitaire De Brest, Brest, France
- Bogdan, BADIC
- Assistance Publique Hopitaux De Paris, Paris, France
-
Centre Hospitalier De Versailles, Le Chesnay Cedex, France
- MARTIN, BRUNEL
- Centre Hospitalier Universitaire Amiens Picardie, Amiens Cedex 1, France
- Hopital Huriez, Lille Cedex, France
- Hospices Civils De Lyon, Pierre Benite, France
-
Centre Hospitalier Universitaire De La Reunion, St Denis, France
- Johanna, ZEMOUR
-
Institut De Cancerologie Strasbourg Europe, Strasbourg, France
- Meher, BEN ABDELGHANI
- Centre Hospitalier Universitaire Rouen, Rouen, France
-
Les Hopitaux Universitaires De Strasbourg, Strasbourg Cedex 2, France
- CECILE, BRIGAND
-
CHRU De Nancy, Vandoeuvre Les Nancy Cedex, France
- ADELINE, GERMAIN
-
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble, Grenoble, France
- HELENE, FLESCH
-
Hopitaux Universitaires Pitie Salpetriere, Paris Cedex 13, France
- FLORENCE, JEUNE
-
Centre Hospitalier Universitaire De Poitiers, Poitiers, France
- yannick, Tourreau
- Groupe Hospitalier Diaconesses Croix Saint Simon, Paris, France