Groupe d'Etude en Oncologie du Quebec

Titre	A Randomized, Double-blind, Placebo-controlled, Phase III Study of Neoadjuvant-Adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Patients With Resectable Gastric and Gastroesophageal Junction Cancer (GC/GEJC)
Protocole ID	MATTERHORN
ClinicalTrials.gov ID	NCT04592913
Type(s) de cancer	Estomac
Phase	Phase III
Type étude	Clinique
Médicament	Durvalumab et FLOT
Institution	CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
Ville	Montréal
Investigateur(trice) principal(e)	Dr Moishe Liberman
Coordonnateur(trice)	Adeline Jouquan 514-890-8000 poste 26214
Statut	Fermé
Date d'activation	22-07-2021
Critètes d'éligibilité	Patients with histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease (Stage II or higher per AJCC 8th edition). Patients must undergo radical surgery. No prior anti-cancer therapy for the current malignancy. World Health Organization (WHO)/ECOG performance status of 0 or 1 at enrollment. Adequate organ and marrow function. Availability of tumor sample prior to study entry. Must have a life expectancy of at least 24 weeks.
Critètes d'exclusion	Patients with peritoneal dissemination or distant metastasis. Patients with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. Contra-indication to any of the study drugs. History of allogeneic organ transplantation.

Groupe d'étude en oncologie du Québec