EORTC-1707-GITCG

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Adjuvant immunotherapy in patients with resected gastric cancer following preoperative chemotherapy with high risk for recurrence (N+ and/or R1): an open label randomized controlled phase-2-study (VESTIGE)

Study documentation

Trial Status	Closed to Patient Entry
Dates	Date of activation: 17-Jul-2019 Date Step1 close: 06-Jun-2022
Data management at EORTC	Yes
Design	Phase 2 Randomized open label
Targeted Sample size	EORTC Groups: 240 - All Groups: 240
Treatment	Drug Fluorouracil, Ipilimumab, Capecitabine, Cisplatin, Docetaxel, Epirubicin, Leucovorin, Oxaliplatin, Nivolumab
Study Staff	Florian Lordick (Study Coordinator) , Universitaetsklinikum Leipzig UCCL-Krebszentrum, Leipzig Jose Casas (TR Scientist) , EORTC Headquarters, Brussels Ilse Coppens (Clinical Operations Assistant) , EORTC Headquarters, Brussels Shani De Coster (Data Manager) , EORTC Headquarters, Brussels Nathalie Elaut (Data Manager) , EORTC Headquarters, Brussels Irina Ghislain (QoL Specialist) , EORTC Headquarters, Brussels Anne Giraut (Clinical Scientist) , EORTC Headquarters, Brussels Liliane Henkes (Lead CRA) , EORTC Headquarters, Brussels Ana Joaquim (Clinical Research Physician) , EORTC Headquarters, Brussels Maren Kristina Knoedler (Study Co-Coordinator) , Universitaetsklinikum Leipzig UCCL-Krebszentrum, Leipzig Belma Malanda (Project Manager) , EORTC Headquarters, Brussels Murielle Mauer (Statistician) , EORTC Headquarters, Brussels Sara Meloen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Anja Mestnik (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels Jerome Rapion (Statistical Analyst) , EORTC Headquarters, Brussels Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Maira Seini (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Jose Silva (Clinical Research Physician) , EORTC Headquarters, Brussels Elizabeth Smyth (Study Co-Coordinator) , University of Oxford -Oncology, Oxford Lien Styns (Data Manager) , EORTC Headquarters, Brussels Katheline Vander Heggen (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels Sofie Verschueren (Clinical Operations Manager) , EORTC Headquarters, Brussels
Type of cancer	Gastric
Participating groups	EORTC Gastrointestinal Tract Cancer Group
Recruiting centers	Azienda Ospedaliera Papa Giovanni XXIII (Bergamo, Italy) CHRU de Lille - Hopital Huriez (Lille, France) Cambridge University Hospital NHS - Addenbrookes Hospital (Cambridge, United Kingdom) Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin (Berlin, Germany) Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (Berlin, Germany) Complejo Hospitalario de Navarra (Pamplona, Spain) Gustave Roussy (VILLEJUIF CEDEX, France) Hopital Prive Jean Mermoz (LYON CEDEX 08, France) Hospital Clinico Universitario De Valencia (Valencia, Spain) Hospital Universitario 12 De Octubre (Madrid, Spain) ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain) IRCCS - Fondazione G. Pascale (Napoli, Italy) Istituto Europeo di Oncologia (Milano, Italy) Kliniken Essen-Mitte (Essen, Germany) Klinikum Rechts der isar Der Technische Universitaet Muenchen - Klinikum Rechts Der Isar (Muenchen, Germany) Maria Sklodowska-Curie National Research Institute of Oncology (Warsaw, Poland) Masaryk Memorial Cancer Institute (Brno, Czech Republic) Oslo University Hospital - Ullevaal Hospital (Oslo, Norway) Rabin Medical Center - Tel Aviv (Petah Tikva, Israel) Rambam Health Care Campus, Oncology Institute (Haifa, Israel) Royal Marsden Hospital - Chelsea, London (London, United Kingdom) Royal Marsden Hospital - Sutton, Surrey (Surrey, United Kingdom) SLK-Kliniken Heilbronn (Heilbronn, Germany) Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center (Hamburg, Germany) Universitaetsklinikum Leipzig UCCL-Krebszentrum (Leipzig, Germany) University College Hospital (London, United Kingdom)
Protocol summary	http://clinicaltrials.gov/study/NCT03443856
NCT number	NCT03443856
EudraCT	2018-000406-36
Financial Support	Educational Grant