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

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ClinicalTrials.gov Identifier: NCT02205047
Recruitment Status : Recruiting
First Posted : July 31, 2014
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief 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.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm of Stomach Malignant Neoplasm of Cardio-esophageal Junction of Stomach Epidermal Growth Factor Receptor (EGFR) Protein Overexpression Drug: Cisplatin Drug: 5-fluorouracil or Capecitabine Drug: Trastuzumab Drug: Pertuzumab Procedure: gastrectomy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: INtegratioN of Trastuzumab, With or Without Pertuzumab, Into periOperatiVe chemotherApy of HER-2 posiTIve stOmach caNcer: the INNOVATION-TRIAL
Study Start Date : September 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
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: 5-fluorouracil or Capecitabine
Drug: Trastuzumab
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: 5-fluorouracil or Capecitabine
Drug: Trastuzumab
Drug: Pertuzumab
Procedure: gastrectomy
D2 gastrectomy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Locoregional failure [ Time Frame: At the time of surgery and at 5 years ]
  2. R0 resection rate [ Time Frame: At the time of surgery ]
  3. Distant failure [ Time Frame: At the time of surgery and at 5 years ]
  4. Progression-free survival [ Time Frame: 5 years after LPI ]
  5. Recurrence-free survival [ Time Frame: 5 years after LPI ]
  6. Overall survival [ Time Frame: 5 years after LPI ]
  7. Toxicity [ Time Frame: 5 years after LPI ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02205047


Contacts
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Contact: Giovanna Farro, PhD 003227741634 giovanna.farro@eortc.be

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Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
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Study Chair: Anna Dorothea Wagner, MD Centre Hospitalier Universitaire Vaudois - Lausanne

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT02205047     History of Changes
Other Study ID Numbers: EORTC-1203-GITCG
2014-000722-38 ( EudraCT Number )
MO28922 ( Other Grant/Funding Number: Roche )
First Posted: July 31, 2014    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: February 2018
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
Neoadjuvant chemotherapy
Additional relevant MeSH terms:
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Pertuzumab
Stomach Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cisplatin
Capecitabine
Trastuzumab
Fluorouracil
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs