Trial record 1 of 1 for:
eortc1203
Neoadjuvant Study Using Trastuzumab or Trastuzumab With Pertuzumab in Gastric or Gastroesophageal Junction Adenocarcinoma (INNOVATION)
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| ClinicalTrials.gov Identifier: NCT02205047 |
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Recruitment Status :
Active, not recruiting
First Posted : July 31, 2014
Last Update Posted : February 16, 2023
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Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
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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 |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 171 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 |
| Actual Study Start Date : | July 15, 2015 |
| Actual Primary Completion Date : | December 22, 2022 |
| Estimated Study Completion Date : | December 31, 2028 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Stomach Cancer
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Standard chemotherapy
Cisplatin/capecitabine or cisplatin/5-fluorouracil
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Drug: Cisplatin Drug: 5-fluorouracil or Capecitabine Procedure: gastrectomy D2 gastrectomy |
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Experimental: Experimental arm 1
Cisplatin/capecitabine plus trastuzumab or cisplatin/5-fluorouracil plus trastuzumab
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Drug: Cisplatin Drug: 5-fluorouracil or Capecitabine Drug: Trastuzumab Procedure: gastrectomy D2 gastrectomy |
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Experimental: Experimental arm 2
cisplatin/capecitabine plus trastuzumab and pertuzumab or cisplatin/5-fluorouracil plus trastuzumab and pertuzumab
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Drug: Cisplatin Drug: 5-fluorouracil or Capecitabine Drug: Trastuzumab Drug: Pertuzumab Procedure: gastrectomy D2 gastrectomy |
Primary Outcome Measures :
- 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 :
- Locoregional failure [ Time Frame: At the time of surgery and at 5 years ]
- R0 resection rate [ Time Frame: At the time of surgery ]
- Distant failure [ Time Frame: At the time of surgery and at 5 years ]
- Progression-free survival [ Time Frame: 5 years after LPI ]
- Recurrence-free survival [ Time Frame: 5 years after LPI ]
- Overall survival [ Time Frame: 5 years after LPI ]
- Toxicity [ Time Frame: 5 years after LPI ]
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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
Locations
Show 43 study locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
| Study Chair: | Anna Dorothea Wagner, MD | Centre hospitalier universitaire vaudois, Lausanne |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT02205047 |
| 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 16, 2023 |
| Last Verified: | February 2023 |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
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Neoadjuvant chemotherapy |
Additional relevant MeSH terms:
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Neoplasms Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Fluorouracil Capecitabine |
Trastuzumab Pertuzumab Antineoplastic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Immunological |