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Brief Title: Ramucirumab Plus FOLFIRI Versus Ramucirumab Plus Paclitaxel in Patients With Advanced or Metastatic Gastric Cancer, Who Failed One Prior Line of Palliative Chemotherapy
Official Title: Ramucirumab Plus Irinotecan / Leucovorin / 5-FU Versus Ramucirumab Plus Paclitaxel in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction, Who Failed One Prior Line of Palliative Chemotherapy - The Phase II/III RAMIRIS Study
Study ID: NCT03081143
Brief Summary: This clinical trial will evaluate whether it is beneficial in terms of prolongation of survival to combine FOLFIRI (standard treatment) with ramucirumab compared to the standard treatment of ramucirumab plus paclitaxel in patients with advanced gastric cancer after failure of one prior line of palliative chemotherapy. This trial aims to investigate the efficacy and safety of ramucirumab plus FOLFIRI (investigational arm A) compared to paclitaxel plus ramucirumab (control arm B).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Ordensklinikum Linz GmbH, Barmherzige Schwestern, Linz, Upper Austria, Austria
Landeskrankenhaus Feldkirch - Rankweil, Rankweil, Vorarlberg, Austria
Wiener Neustadt, Landesklinikum, Wiener Neustadt, , Austria
HELIOS Klinikum Bad Saarow, Bad Saarow, , Germany
Charité - Universitätsmedizin Berlin, Berlin, , Germany
HELIOS Klinikum Berlin Buch, Berlin, , Germany
Klinikum Bielefeld Mitte, Bielefeld, , Germany
Kliniken Essen Mitte, Essen, , Germany
Krankenhaus Nordwest, Frankfurt, , Germany
Hämatologisch-Onkologische Praxis Eppendorf (HOPE), Hamburg, , Germany
Ortenau Klinikum, Lahr, , Germany
Universitäres Krebszentrum Leipzig, Leipzig, , Germany
Technische Universität München, Muenchen, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
U.O. Oncologia Medica, Università Cattolica Sacro Cuore, Rom, , Italy
Name: Salah-Eddin Al-Batran, Prof
Affiliation: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Role: STUDY_CHAIR