Study

EORTC-1203-GITCG

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

Study documentation Back to result

Trial Status

LT-FU ongoing

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
  • Davide Passariello (Project Manager), EORTC Headquarters, Brussels
  • Jose Silva (Clinical Research Physician), EORTC Headquarters, Brussels
  • Stephanie Antunes (Clinical Scientist), EORTC Headquarters, Brussels
  • Anne Giraut (Clinical Scientist), EORTC Headquarters, Brussels
  • Bryan Leurquin (Statistician), EORTC Headquarters, Brussels
  • Murielle Mauer (Statistician), EORTC Headquarters, Brussels
  • Jerome Rapion (Statistical Analyst), EORTC Headquarters, Brussels
  • Ellen Peeters (Clinical Operations Manager), EORTC Headquarters, Brussels
  • Elizangela Fonseca (Junior Clinical Operations Manager), EORTC Headquarters, Brussels
  • Peter De Burghgraeve (Data Manager), EORTC Headquarters, Brussels
  • Nathalie Elaut (Data Manager), EORTC Headquarters, Brussels
  • Lore Meelberghs (Data Manager), EORTC Headquarters, Brussels
  • Konstantina Tsechilidou (Data Manager), EORTC Headquarters, Brussels
  • Sara Meloen (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Sandrine Rivrain (Pharmacovigilance Manager), EORTC Headquarters, Brussels
  • Luminita Copaceanu (Lead CRA), EORTC Headquarters, Brussels
  • Cedric Mallien (TR Manager), EORTC Headquarters, Brussels
  • Alexandra Latteux (Clinical Operations Assistant), 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 stichting - Locatie AMC (Amsterdam, Netherlands)
  • Amsterdam UMC stichting - 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)
  • CHRU de Besancon - Hopital Jean Minjoz (BESANCON CEDEX, France)
  • CHU de Bordeaux - Group Hospitalier Sud - Hopital Haut-Lévêque (PESSAC CEDEX, France)
  • CHU de Lille - Hopital Huriez (Lille, 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)
  • 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)
  • 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