Study Evaluating the Tailored Management of Locally-advanced Rectal Carcinoma
Recruiting now · Phase 2/Phase 3
Conditions studied: Locally Advanced Malignant Neoplasm, Rectal Carcinoma
In brief
Locally advanced rectal carcinoma raise the issue of both the oncological control, local and general, and the therapeutic morbidity. Surgery alone can cure only one out of two patients, radiochemotherapy improves the local control but the metastatic risk remains about 30% with enhanced postoperative morbidity and poor functional results. The tumor response to preoperative treatment is the major prognostic factor which revealed the aggressiveness of the tumor. To this day, there are no biologic predictive markers for tumor response. The purpose of this trial is to tailor the management according to the early tumoral response after short and intensive induction chemotherapy. MRI volumetric tumor response will be used to distinguish between good responders and bad responders. "Very good" responders will be randomized to either immediate surgery or radiochemotherapy followed by surgery (Standard arm: Cap 50).
Key facts
- Study ID
- NCT04749108
- Run by
- Institut du Cancer de Montpellier - Val d'Aurelle
- People needed
- 1075
- Starts
- 2021-11-26
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2026-02-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- CHU de Toulouse — Toulouse, France (enrolling)
- Hôpital Diaconesses — Paris, France (enrolling)
- Institut de Cancérologie de l'Ouest — Saint-Herblain, France (enrolling)
- Institut Paoli Calmettes — Marseille, Bouches Du Rhône, France (enrolling)
- Hôpital Européen de MARSEILLE — Marseille, Bouches-du-rhône, France (enrolling)
- CHU Besançon — Besançon, Doubs, France (enrolling)
- CHU de Bordeaux — Bordeaux, Gironde, France (enrolling)
- Insitut Régional du Cancer de Montpellier — Montpellier, Hérault, France (enrolling)
- CHU de Nancy — Vandœuvre-lès-Nancy, Lorraine, France (enrolling)
- Centre Alexis Vautrin — Nancy, Meurthe Et Moselle, France (enrolling)
- Centre Oscart Lambret — Lille, Nord, France (enrolling)
- CHU Amiens — Amiens, Picardie, France (enrolling)
- CHU Clermont-Ferrand — Clermont-Ferrand, Puy De Dôme, France (enrolling)
- CH PAU — Pau, Pyrénées-atlantiques, France (enrolling)
- CHU de Lyon — Lyon, Rhône, France (enrolling)
- CHU Rouen — Rouen, Seine-Maritime, France (enrolling)
- Hôpital Bicêtre — Le Kremlin-Bicêtre, Val De Marne, France (enrolling)
- Bordeaux Colorectal Institute — Bordeaux, France (enrolling)
- Chu Grenoble — Grenoble, France (enrolling)
- Chu Lille — Lille, France (enrolling)
- CAC Léon Bérard — Lyon, France (enrolling)
- Hôpital La Timone — Marseille, France (enrolling)
- Centre Antoine Lacassagne — Nice, France (enrolling)
- CHU de Nîmes — Nîmes, France (enrolling)
- Hôpital Saint-Louis — Paris, France (enrolling)
Full record on ClinicalTrials.gov
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