Neoadjuvant Study Using Trastuzumab or Trastuzumab With Pertuzumab in Gastric or Gastroesophageal Junction Adenocarcinoma
NCT ID: NCT02205047
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
172 participants
INTERVENTIONAL
2015-07-15
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard chemotherapy
Cisplatin/capecitabine or cisplatin/5-fluorouracil
Cisplatin
5-fluorouracil or Capecitabine
gastrectomy
D2 gastrectomy
Experimental arm 1
Cisplatin/capecitabine plus trastuzumab or cisplatin/5-fluorouracil plus trastuzumab
Cisplatin
5-fluorouracil or Capecitabine
Trastuzumab
gastrectomy
D2 gastrectomy
Experimental arm 2
cisplatin/capecitabine plus trastuzumab and pertuzumab or cisplatin/5-fluorouracil plus trastuzumab and pertuzumab
Cisplatin
5-fluorouracil or Capecitabine
Trastuzumab
Pertuzumab
gastrectomy
D2 gastrectomy
Interventions
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Cisplatin
5-fluorouracil or Capecitabine
Trastuzumab
Pertuzumab
gastrectomy
D2 gastrectomy
Eligibility Criteria
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Inclusion Criteria
* Patient medically fit for gastrectomy/oesophagogastrectomy as decided by the investigator
* Age ≥ 18 years
* WHO performance status 0 - 1
* HER-2 overexpression
* Amenable to gastrectomy/oesophagectomy
* The cardiac ejection fraction (LVEF), as determined by echocardiography, multiple gated acquisition scan (MUGA) or cardiac MRI should be at least 50 %
* Adequate organ function
* written informed consent
* For women who are not postmenopausal (\> 12 months of non-therapy induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 12 months after the last treatment dose
* For men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and for at least 12 months after the last dose of study treatment. Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods for contraception.
Exclusion Criteria
* prior chemo- or antibody therapy
* history of significant cardiac disease
* current uncontrolled hypertension
* known hypersensitivity to the components of trastuzumab, pertuzumab, cisplatin, 5-follow-up or capecitabine
* known dihydropyrimidine dehydrogenase (DPD) deficiency
* ongoing or concomitant use of the antiviral drug sorivudine or its chemically related analogs, such as brivudine
* chronic treatment with high-dose intravenous corticosteroids
* previous malignancy within the last 5 years, with the exception of adequately treated cervical carcinoma in situ, localized non-melanoma skin cancer, or other curatively treated cancer without impact on the patient's overall prognosis according to the judgment of the investigator.
* psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* pregnant or breast feeding
18 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Anna Dorothea Wagner, MD
Role: STUDY_CHAIR
Centre hospitalier universitaire vaudois, Lausanne
Locations
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University Hospital Gent
Ghent, Flanders, Belgium
North Estonia Medical Centre
Tallinn, , Estonia
CHRU de Besancon - Hopital Jean Minjoz
Besançon, , France
CHRU de Lille - Hopital Huriez
Lille, , France
CHU de Bordeaux - Group Hospitalier Sud - Hopital Haut-Lévêque
Pessac, , France
CHU de Reims - Hôpital Robert Debré
Reims, , France
Institut Gustave Roussy
Villejuif, , France
Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum
Berlin, , Germany
Universitaetsklinikum Carl Gustav Carus
Dresden, , Germany
Kliniken Essen-Mitte - Evang. Huyssens-Stiftung
Essen, , Germany
Universitaetsmedizin Goettingen - Georg-August Universitaet
Göttingen, , Germany
Asklepios Kliniken GmbH - Asklepios Klinik Barmbek
Hamburg, , Germany
SLK-Kliniken Heilbronn GmbH
Heilbronn, , Germany
Onkologische Unter-Ems (Leer-Papenburg-Emden)
Leer, , Germany
Universitaetsklinikum Leipzig
Leipzig, , Germany
Johannes Gutenberg Universitaetskliniken - Mainz University Medical Center
Mainz, , Germany
Ludwig-Maximilians-Universitaet München - Campus Grosshadern
München, , Germany
Technische Universität München - Klinikum Rechts der Isar
München, , Germany
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, , Italy
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
Amsterdam, , Netherlands
Academisch Medisch Centrum - UMC Universiteit van Amsterdam - site: VUMC
Amsterdam, , Netherlands
Oslo University Hospital - Radiumhospitalet
Oslo, , Norway
Instituto Portugues de Oncologia de Lisboa Francisco Gentil
Lisbon, , Portugal
Instituto Portugues De Oncologia - Centro Do Porto
Porto, , Portugal
National Cancer Centre Singapore
Singapore, , Singapore
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Hallym University Sacred Heart Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Hallym University Sacred Heart Hospital
Seoul, , South Korea
Severance Hospital YUCM
Seoul, , South Korea
Severance Hospital, Yonsei University Health System (YUCM)
Seoul, , South Korea
The Catholic University of Korea-St. Vincent's Hospital
Suwon-Si Gyeonggi-do, , South Korea
Institut Catala d'Oncologia - ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
ICO Badalona (Institut Catala d'Oncologia) - Hospital Germans Trias i Pujol
Badalona, , Spain
Hospital Universitari Vall d'Hebron - Institut Oncologia
Barcelona, , Spain
ICO Girona - Hospital Dr Josep Trueta (Institut Catala d'Oncologia)
Girona, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Clinico Universitario De Valencia
Valencia, , Spain
Hôpitaux Universitaires de Genève - HUG
Geneva, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
University Hospitals Birmingham NHS - UHB-Queen Elisabeth MC
Birmingham, , United Kingdom
University College London Hospitals (UCLH) - NHS Foundation Trust
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Royal Marsden Hospital - site: Sutton, Surrey
Sutton, , United Kingdom
Countries
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References
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Wagner AD, Grabsch HI, Mauer M, Marreaud S, Caballero C, Thuss-Patience P, Mueller L, Elme A, Moehler MH, Martens U, Kang YK, Rha SY, Cats A, Tokunaga M, Lordick F. EORTC-1203-GITCG - the "INNOVATION"-trial: Effect of chemotherapy alone versus chemotherapy plus trastuzumab, versus chemotherapy plus trastuzumab plus pertuzumab, in the perioperative treatment of HER2 positive, gastric and gastroesophageal junction adenocarcinoma on pathologic response rate: a randomized phase II-intergroup trial of the EORTC-Gastrointestinal Tract Cancer Group, Korean Cancer Study Group and Dutch Upper GI-Cancer group. BMC Cancer. 2019 May 24;19(1):494. doi: 10.1186/s12885-019-5675-4.
Integration of Trastuzumab, with or without Pertuzumab, into Perioperative Chemotherapy of HER2- Positive Stomach Cancer: The INNOVATION Trial (EORTC-1203-GITCG). Oncol Res Treat. 2016;39(3):153-4; discussion 155. doi: 10.1159/000444702. No abstract available.
Other Identifiers
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2014-000722-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MO28922
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
EORTC-1203-GITCG
Identifier Type: -
Identifier Source: org_study_id
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