Studieninformationen
Kurztitel:
Matterhorn
Beschreibung:
A Randomized, Double-blind, Placebo-controlled, Phase III Study of Neoadjuvant-Adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN)
Studiendesign:
Phase III, , Peer Reviewed, Multizentrisch, International
Therapielinien:
,
Alter:
18 Jahre - 200 Jahre
Erkrankungen:
Ein-/Ausschlusskriterien:
Key Inclusion Criteria: 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. Key Exclusion Criteria: 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.
NCT-Nummer:
Eudract-Nummer:
Studienaktive Standorte
common:study_status_active
Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH
Medizinische Klinik II
Herr Prof. Dr. Stephan Kanzler
skanzler@leopoldina.de
Herr Dr. Michael Brück
mbrueck@leopoldina.de