Neoadjuvant Study Using Trastuzumab or Trastuzumab With Pertuzumab in Gastric or Gastroesophageal Junction Adenocarcinoma (INNOVATION)

July 30, 2025 updated by: European Organisation for Research and Treatment of Cancer - EORTC

INtegratioN of Trastuzumab, With or Without Pertuzumab, Into periOperatiVe chemotherApy of HER-2 posiTIve stOmach caNcer: the INNOVATION-TRIAL

The purpose of this study is to find out whether either trastuzumab or the combination of trastuzumab and pertuzumab with standard chemotherapy shows more activity against gastro-oesophageal adenocarcinoma than standard chemotherapy given before and after surgery and it can be safely administered.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized phase II trial with an internal control. The randomization will be a 1:2:2 randomization (control: experimental arm 1: experimental arm 2). Potentially eligible patients will be screened centrally for the HER-2 status. After confirmation of HER-2 positive disease, eligible patients will be centrally randomized through the EORTC randomization system. A minimization technique will be used for random treatment allocation between the three treatment arms. Stratification will be done by histological subtype (intestinal/non-intestinal); Korea versus Europe; stage II versus III; node positive versus node negative.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
172

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaanderen
      • Gent, Vlaanderen, Belgium, 9000
        • University Hospital Gent
  • Estonia
      • Tallinn, Estonia, 13419
        • North Estonia Medical Centre
  • France
      • Besançon, France, 25030
        • CHRU de Besancon - Hopital Jean Minjoz
      • Lille, France, 59037
        • CHRU de Lille - Hopital Huriez
      • Pessac, France, 33075
        • CHU de Bordeaux - Group Hospitalier Sud - Hopital Haut-Lévêque
      • Reims, France, 51092
        • CHU de Reims - Hôpital Robert Debré
      • Villejuif, France
        • Institut Gustave Roussy
  • Germany
      • Berlin, Germany, 13353
        • Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum
      • Dresden, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus
      • Essen, Germany, 45136
        • Kliniken Essen-Mitte - Evang. Huyssens-Stiftung
      • Göttingen, Germany, 37075
        • Universitaetsmedizin Goettingen - Georg-August Universitaet
      • Hamburg, Germany, 22291
        • Asklepios Kliniken GmbH - Asklepios Klinik Barmbek
      • Heilbronn, Germany, 74078
        • SLK-Kliniken Heilbronn GmbH
      • Leer, Germany, 26789
        • Onkologische Unter-Ems (Leer-Papenburg-Emden)
      • Leipzig, Germany
        • Universitaetsklinikum Leipzig
      • Mainz, Germany, 55101
        • Johannes Gutenberg Universitaetskliniken - Mainz University Medical Center
      • München, Germany, 81377
        • Ludwig-Maximilians-Universitaet München - Campus Grosshadern
      • München, Germany
        • Technische Universität München - Klinikum Rechts der Isar
  • Italy
      • Bergamo, Italy, 24127
        • Azienda Ospedaliera Papa Giovanni XXIII
      • Milano, Italy, 20141
        • Istituto Europeo di Oncologia
      • Torino, Italy
        • Azienda Ospedaliera Ordine Mauriziano di Torino
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of, 135-720
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Hallym University Sacred Heart Hospital
      • Seoul, Korea, Republic of, 14068
        • Hallym University Sacred Heart Hospital
      • Seoul, Korea, Republic of
        • Severance Hospital YUCM
      • Seoul, Korea, Republic of
        • Severance Hospital, Yonsei University Health System (YUCM)
      • Suwon-Si Gyeonggi-do, Korea, Republic of, 16247
        • The Catholic University of Korea-St. Vincent's Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
      • Amsterdam, Netherlands, 1081 HV
        • Academisch Medisch Centrum - UMC Universiteit van Amsterdam - site: VUMC
  • Norway
      • Oslo, Norway, 0379
        • Oslo University Hospital - Radiumhospitalet
  • Portugal
      • Lisboa, Portugal
        • Instituto Português de Oncologia de Lisboa Francisco Gentil
      • Porto, Portugal, 4200-072
        • Instituto Portugues De Oncologia - Centro Do Porto
  • Singapore
      • Singapore, Singapore, 169610
        • National Cancer Centre Singapore
  • Spain
      • Badalona, Spain, 08916
        • ICO Badalona (Institut Catala d'Oncologia) - Hospital Germans Trias i Pujol
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron - Institut Oncologia
      • Girona, Spain, 17007
        • ICO Girona - Hospital Dr Josep Trueta (Institut Catala d'Oncologia)
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon Y Cajal
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario De Valencia
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Institut Catala d'Oncologia - ICO L'Hospitalet
  • Switzerland
      • Geneve, Switzerland, 1211
        • Hôpitaux Universitaires de Genève - HUG
      • Lausanne, Switzerland
        • Centre hospitalier universitaire vaudois
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • University Hospitals Birmingham NHS - UHB-Queen Elisabeth MC
      • London, United Kingdom
        • University College London Hospitals (UCLH) - NHS Foundation Trust
      • Manchester, United Kingdom
        • The Christie NHS Foundation Trust
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Hospital - site: Sutton, Surrey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically proven, gastric or gastroesophageal (GE)-junction adenocarcinoma (Siewert I-III)
  • 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:

  • Absence of distant metastases on CT scan of thorax and abdomen
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard chemotherapy
Cisplatin/capecitabine or cisplatin/5-fluorouracil
Drug: Cisplatin
Drug: 5-fluorouracil or Capecitabine
Procedure: gastrectomy
D2 gastrectomy
Experimental: Experimental arm 1
Cisplatin/capecitabine plus trastuzumab or cisplatin/5-fluorouracil plus trastuzumab
Drug: Cisplatin
Drug: Trastuzumab
Drug: 5-fluorouracil or Capecitabine
Procedure: gastrectomy
D2 gastrectomy
Experimental: Experimental arm 2
cisplatin/capecitabine plus trastuzumab and pertuzumab or cisplatin/5-fluorouracil plus trastuzumab and pertuzumab
Drug: Cisplatin
Drug: Pertuzumab
Drug: Trastuzumab
Drug: 5-fluorouracil or Capecitabine
Procedure: gastrectomy
D2 gastrectomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Near Complete Pathological Response Rate
Time Frame: After 3 cycles (21 days) of neoadjuvant chemotherapy
To increase the major pathological response rate (< 10% vital tumor cells) to neoadjuvant treatment by integrating both trastuzumab and pertuzumab into perioperative chemotherapy for HER-2 positive, resectable gastric cancer.
After 3 cycles (21 days) of neoadjuvant chemotherapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Locoregional failure
Time Frame: At the time of surgery and at 5 years
At the time of surgery and at 5 years
R0 resection rate
Time Frame: At the time of surgery
At the time of surgery
Distant failure
Time Frame: At the time of surgery and at 5 years
At the time of surgery and at 5 years
Progression-free survival
Time Frame: 5 years after LPI
5 years after LPI
Recurrence-free survival
Time Frame: 5 years after LPI
5 years after LPI
Overall survival
Time Frame: 5 years after LPI
5 years after LPI
Toxicity
Time Frame: 5 years after LPI
5 years after LPI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
European Organisation for Research and Treatment of Cancer - EORTC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Anna Dorothea Wagner, MD, Centre hospitalier universitaire vaudois, Lausanne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 22, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EORTC-1203-GITCG
  • 2014-000722-38 (EudraCT Number)
  • MO28922 (Other Grant/Funding Number: Roche)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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