Clinical Trial Details

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 Publications

Trial Status Recruiting
Dates Date of activation: 02-Sep-2015
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, Oxalilplatin, Trastuzumab
Study Staff Anna Dorothea Wagner (Study Coordinator) , Centre Hospitalier Universitaire Vaudois - Lausanne, Lausanne
Peter De Burghgraeve (Data Manager) , EORTC Headquarters, Brussels
Nathalie Elaut (Data Manager) , EORTC Headquarters, Brussels
Anne Giraut (Clinical Scientist) , EORTC Headquarters, Brussels
Sofia Gomes (Clinical Operations Manager) , EORTC Headquarters, Brussels
Amaya Gonzalez (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels
Marsha Greene (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels
Cedric Mallien (Junior Clinical Operations Manager) , EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels
Murielle Mauer (Statistician) , EORTC Headquarters, Brussels
Lore Meelberghs (Data Manager) , EORTC Headquarters, Brussels
Fiona Namanya (Clinical Operations Assistant) , EORTC Headquarters, Brussels
Diem Chi Nguyen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Ellen Peeters (Project Manager) , EORTC Headquarters, Brussels
Khadija Rhioui (Junior Clinical Operations Manager) , EORTC Headquarters, Brussels
Maira Seini (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Yuko Takahashi (Fellow) , EORTC Headquarters, Brussels
Katheline Vander Heggen (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels
Tomas Verdeyen (Data Manager) , EORTC Headquarters, Brussels
Christine de Balincourt (Lead CRA) , 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)
Asan Medical Center (Seoul, Korea (Republic of))
Asklepios Klinik Barmbek (Hamburg, Germany)
Azienda Ospedaliera Papa Giovanni XXIII (Bergamo, Italy)
CHRU de Besancon - Hopital Jean Minjoz (Besancon, France)
CHU de Bordeaux - Group Hospitalier Sud - Hopital Haut-Lévêque (Pessac, France)
CHU de Reims - Hopital Robert Debre (Reims, France)
Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland)
Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (Berlin, Germany)
Gangnam Severance Hospital (Seoul, Korea (Republic of))
Gustave Roussy (Villejuif, France)
Hallym University Sacred Heart Hospital (Seoul, Korea (Republic of))
Hopital Universitaire Brugmann (Brussels, Belgium)
Hospital Clinico Universitario De Valencia (Valencia, Spain)
Hospital Universitario Ramon y Cajal (Madrid, Spain)
Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie (Geneve, Switzerland)
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)
Instituto Portugues De Oncologia - Francisco Gentil - Centro De Lisboa (Lisboa, Portugal)
Instituto Portugues de Oncologia do Porto (Porto, Portugal)
Istituto Europeo di Oncologia (Milano, Italy)
Kliniken Essen-Mitte (Essen, Germany)
Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern (Muenchen, Germany)
National Cancer Centre (Singapore, Singapore)
North Estonia Medical Centre - Mustamäe unit (Tallinn, Estonia)
Onkologie UnterEms, Leer-Papenburg-Emden (Leer, Germany)
Oslo University Hospital - Ullevaal Hospital (Oslo, Norway)
Rabin Medical Center - Tel Aviv (Petah Tikva, Israel)
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))
Technische Universitaet Muenchen - Klinikum Rechts Der Isar (Muenchen, Germany)
The Catholic University of Korea-St. Vincent's Hospital (Suwon-Si Gyeonggi-do, Korea (Republic of))
The Christie NHS Foundation Trust (Manchester, United Kingdom)
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands)
Universitaetsklinikum Carl Gustav Carus (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)
Vall d'Hebron Institut Oncologia (Barcelona, Spain)
Centers to be activated Amsterdam UMC - locatie VUmc (Amsterdam, Netherlands)
Azienda Ospedaliera Ordine Mauriziano di Torino (Torino, Italy)
CHRU de Lille - Hopital Huriez (Lille, France)
Leiden University Medical Centre (Leiden, Netherlands)
UHB-Queen Elisabeth Medical Centre (Birmingham, United Kingdom)
Vall d'Hebron Institut Oncologia (Barcelona, Spain)
Protocol summary http://clinicaltrials.gov/ct/show/NCT02205047
NCT number NCT02205047
EudraCT 2014-000722-38
Financial Support Educational Grant