EORTC-1203-GITCG

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INtegratioN of trastuzumab, with or without pertuzumab, into periOperatiVe chemotherApy of HER-2 posiTIve stOmach caNcer: the INNOVATION-TRIAL

Study documentation

Trial Status	Closed to Patient Entry
Dates	Date of activation: 02-Sep-2015 Date Step1 close: 11-Jan-2022 Date Step2 close: 11-Jan-2022
Data management at EORTC	Yes
Design	Phase 2 Randomized open label
Targeted Sample size	EORTC Groups: 161 - All Groups: 215
Treatment	Surgery, Drug Fluorouracil, Capecitabine, Cisplatin, Docetaxel, Leucovorin, Pertuzumab, Oxaliplatin, Trastuzumab
Study Staff	Anna Dorothea Wagner (Study Coordinator) , Centre Hospitalier Universitaire Vaudois - Lausanne, Lausanne Stephanie Antunes (Clinical Scientist) , EORTC Headquarters, Brussels Emanuel Buhrer (Project Physician) , EORTC Headquarters, Brussels Ilse Coppens (Clinical Operations Assistant) , EORTC Headquarters, Brussels Peter De Burghgraeve (Data Manager) , EORTC Headquarters, Brussels Nathalie Elaut (Data Manager) , EORTC Headquarters, Brussels Anne Giraut (Clinical Scientist) , EORTC Headquarters, Brussels Amaya Gonzalez (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Cedric Mallien (TR Manager) , EORTC Headquarters, Brussels Murielle Mauer (Statistician) , EORTC Headquarters, Brussels Lore Meelberghs (Data Manager) , EORTC Headquarters, Brussels Sara Meloen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Pablo Oriol (Junior Clinical Operations Manager) , EORTC Headquarters, Brussels Davide Passariello (Project Manager) , EORTC Headquarters, Brussels Jerome Rapion (Statistical Analyst) , EORTC Headquarters, Brussels Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Nathalie Ropson (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Maira Seini (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Konstantina Tsechilidou (Data Manager) , EORTC Headquarters, Brussels Katheline Vander Heggen (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels
Type of cancer	Gastric Esophageal
Participating groups	EORTC Gastrointestinal Tract Cancer Group Korean Cancer Study Group Dutch Upper GI Group
Recruiting centers	Amsterdam UMC - Locatie AMC (Amsterdam, Netherlands) Amsterdam UMC - locatie VUMC (Amsterdam, Netherlands) Asan Medical Center (Seoul, Korea (Republic of)) Asklepios Tumorzentrum Hamburg AK Barmbek (Hamburg, Germany) Azienda Ospedaliera Ordine Mauriziano di Torino (Torino, Italy) Azienda Ospedaliera Papa Giovanni XXIII (Bergamo, Italy) CHRU de Besancon - Hopital Jean Minjoz (BESANCON CEDEX, France) CHRU de Lille - Hopital Huriez (Lille, France) CHU de Bordeaux - Group Hospitalier Sud - Hopital Haut-Lévêque (PESSAC CEDEX, France) CHU de Reims - Hopital Robert Debre (REIMS CEDEX, France) Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland) Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (Berlin, Germany) Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (Berlin, Germany) Gangnam Severance Hospital (Seoul, Korea (Republic of)) Gustave Roussy (VILLEJUIF CEDEX, France) Hallym University Sacred Heart Hospital (Seoul, Korea (Republic of)) Hopitaux universitaires de Geneve - HUG - site de Cluse-Roseraie (Geneve, Switzerland) Hospital Clinico Universitario De Valencia (Valencia, Spain) Hospital Universitari Vall d’Hebron -Vall d'Hebron Institut Oncologia (Barcelona, Spain) Hospital Universitario Ramon y Cajal (Madrid, Spain) ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain) ICO Girona - Hospital Doctor Josep Trueta (Institut Catala D'Oncologia) (Girona, Spain) ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain) ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain) Instituto Portugues de Oncologia de Lisboa Francisco Gentil – EPE (Lisboa, Portugal) Instituto Portugues de Oncologia do Porto Francisco Gentil (Porto, Portugal) 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) Leiden University Medical Centre (Leiden, Netherlands) Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern (Muenchen, Germany) MVM MbH -Onkologie UnterEms, Leer-Papenburg-Emden (Leer, Germany) National Cancer Centre - Singapore (Singapore, Singapore) North Estonia Medical Centre - Mustamae unit (Tallinn, Estonia) Oslo University Hospital - Ullevaal Hospital (Oslo, Norway) Royal Marsden Hospital - Chelsea, London (London, United Kingdom) Royal Marsden Hospital - Sutton, Surrey (Surrey, United Kingdom) SLK-Kliniken Heilbronn (Heilbronn, Germany) Severance Hospital, Yonsei University Health System ( YUCM) (Seoul, Korea (Republic of)) The Christie NHS Foundation Trust (Manchester, United Kingdom) The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands) UHB-Queen Elizabeth Medical Centre (Birmingham, United Kingdom) Universitaetsklinikum Carl Gustav Carus (TUD) (Dresden, Germany) Universitaetsklinikum Leipzig UCCL-Krebszentrum (Leipzig, Germany) Universitaetsmedizin Goettingen - Georg-August Universitaet (Goettingen, Germany) Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center (Mainz, Germany) Universitair Ziekenhuis Gent (Gent, Belgium) University College Hospital (London, United Kingdom)
Protocol summary	http://clinicaltrials.gov/study/NCT02205047
NCT number	NCT02205047
EudraCT	2014-000722-38
Financial Support	Educational Grant