AzTrials
AzTrials

Malignant Neoplasm of StomachPhase 2INNOVATIONNCT02205047

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

A Phase 2 study testing Cisplatin, 5-fluorouracil or Capecitabine and Trastuzumab in people with Malignant Neoplasm of Stomach and Malignant Neoplasm of Cardio-esophageal Junction of Stomach, run by European Organisation for Research and Treatment of Cancer - EORTC at 48 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cisplatin, 5-fluorouracil or Capecitabine and Trastuzumab
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
48 sitesin 13 countries
Study dates
15 Jul 2015to 31 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

48 sites in 13 countries.

48 sites in 13 countries

Germany11 sites

  • Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum

    Berlin, 13353

  • Universitaetsklinikum Carl Gustav Carus

    Dresden, 01307

  • Kliniken Essen-Mitte - Evang. Huyssens-Stiftung

    Essen, 45136

  • Universitaetsmedizin Goettingen - Georg-August Universitaet

    Göttingen, 37075

  • Asklepios Kliniken GmbH - Asklepios Klinik Barmbek

    Hamburg, 22291

  • SLK-Kliniken Heilbronn GmbH

    Heilbronn, 74078

  • Onkologische Unter-Ems (Leer-Papenburg-Emden)

    Leer, 26789

  • Universitaetsklinikum Leipzig

    Leipzig

  • Johannes Gutenberg Universitaetskliniken - Mainz University Medical Center

    Mainz, 55101

  • Ludwig-Maximilians-Universitaet München - Campus Grosshadern

    München, 81377

  • Technische Universität München - Klinikum Rechts der Isar

    München

Other trials in Germany

South Korea9 sites

  • Asan Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital

    Seoul, 135-720

  • Hallym University Sacred Heart Hospital

    Seoul, 14068

  • Asan Medical Center

    Seoul

  • Gangnam Severance Hospital

    Seoul

  • Hallym University Sacred Heart Hospital

    Seoul

  • Severance Hospital YUCM

    Seoul

  • Severance Hospital, Yonsei University Health System (YUCM)

    Seoul

  • The Catholic University of Korea-St. Vincent's Hospital

    Suwon-Si Gyeonggi-do, 16247

Other trials in South Korea

Spain6 sites

  • ICO Badalona (Institut Catala d'Oncologia) - Hospital Germans Trias i Pujol

    Badalona, 08916

  • Hospital Universitari Vall d'Hebron - Institut Oncologia

    Barcelona, 08035

  • ICO Girona - Hospital Dr Josep Trueta (Institut Catala d'Oncologia)

    Girona, 17007

  • Institut Catala d'Oncologia - ICO L'Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Clinico Universitario De Valencia

    Valencia, 46010

Other trials in Spain

France5 sites

  • CHRU de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • CHRU de Lille - Hopital Huriez

    Lille, 59037

  • CHU de Bordeaux - Group Hospitalier Sud - Hopital Haut-Lévêque

    Pessac, 33075

  • CHU de Reims - Hôpital Robert Debré

    Reims, 51092

  • Institut Gustave Roussy

    Villejuif

Other trials in France

United Kingdom4 sites

  • University Hospitals Birmingham NHS - UHB-Queen Elisabeth MC

    Birmingham, B15 2TH

  • University College London Hospitals (UCLH) - NHS Foundation Trust

    London

  • The Christie NHS Foundation Trust

    Manchester

  • Royal Marsden Hospital - site: Sutton, Surrey

    Sutton, SM2 5PT

Other trials in United Kingdom

Italy3 sites

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127

  • Istituto Europeo di Oncologia

    Milan, 20141

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino

Other trials in Italy

Netherlands2 sites

  • The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

    Amsterdam, 1066 CX

  • Academisch Medisch Centrum - UMC Universiteit van Amsterdam - site: VUMC

    Amsterdam, 1081 HV

Other trials in Netherlands

Portugal2 sites

  • Instituto Portugues de Oncologia de Lisboa Francisco Gentil

    Lisbon

  • Instituto Portugues De Oncologia - Centro Do Porto

    Porto, 4200-072

Other trials in Portugal

Switzerland2 sites

  • Hôpitaux Universitaires de Genève - HUG

    Geneva, 1211

  • Centre Hospitalier Universitaire Vaudois

    Lausanne

Other trials in Switzerland

Belgium1 site

  • University Hospital Gent

    Ghent, Flanders, 9000

Other trials in Belgium

Estonia1 site

  • North Estonia Medical Centre

    Tallinn, 13419

Other trials in Estonia

Norway1 site

  • Oslo University Hospital - Radiumhospitalet

    Oslo, 0379

Other trials in Norway

Singapore1 site

  • National Cancer Centre Singapore

    Singapore, 169610

Other trials in Singapore

About this study

Official title: 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.

Read the 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.

Being tested
Cisplatin, 5-fluorouracil or Capecitabine, Trastuzumab, Pertuzumab, gastrectomy
Keywords
Neoadjuvant chemotherapy
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02205047
Study groupRoleWhat they receive
Standard chemotherapyActive comparatorCisplatin/capecitabine or cisplatin/5-fluorouracil
Receives: Drug: Cisplatin; Drug: 5-fluorouracil or Capecitabine; Procedure: gastrectomy
Experimental arm 1ExperimentalCisplatin/capecitabine plus trastuzumab or cisplatin/5-fluorouracil plus trastuzumab
Receives: Drug: Cisplatin; Drug: 5-fluorouracil or Capecitabine; Drug: Trastuzumab; Procedure: gastrectomy
Experimental arm 2Experimentalcisplatin/capecitabine plus trastuzumab and pertuzumab or cisplatin/5-fluorouracil plus trastuzumab and pertuzumab
Receives: Drug: Cisplatin; Drug: 5-fluorouracil or Capecitabine; Drug: Trastuzumab; Drug: Pertuzumab; Procedure: gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Near Complete Pathological Response Rate

    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.

    Measured: After 3 cycles (21 days) of neoadjuvant chemotherapy

Secondary outcomes (7)

  1. Locoregional failure

    Measured: At the time of surgery and at 5 years

  2. R0 resection rate

    Measured: At the time of surgery

  3. Distant failure

    Measured: At the time of surgery and at 5 years

  4. Progression-free survival

    Measured: 5 years after LPI

  5. Recurrence-free survival

    Measured: 5 years after LPI

  6. Overall survival

    Measured: 5 years after LPI

  7. Toxicity

    Measured: 5 years after LPI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2014 (estimated)
  2. Study start15 Jul 2015
  3. Primary completion22 Dec 2022
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02205047
Sponsor's protocol ID
EORTC-1203-GITCG
Other IDs
2014-000722-38, MO28922, 2014
Acronym
INNOVATION
Status last verified
Jul 2025
First submitted
10 Jul 2014
Last updated
31 Jul 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 31126258

  • 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.

    PubMed 27486629

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cisplatin, 5-fluorouracil or Capecitabine and Trastuzumab in people with Malignant Neoplasm of Stomach and Malignant Neoplasm of Cardio-esophageal Junction of Stomach, run by European Organisation for Research and Treatment of Cancer - EORTC at 48 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in Germany, South Korea, Spain, France, United Kingdom and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Near Complete Pathological Response Rate (time frame: After 3 cycles (21 days) of neoadjuvant chemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02205047, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in