Clinical Trials /

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

NCT02205047

Description:

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.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Gastric Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Neoadjuvant Study Using <span class="go-doc-concept go-doc-intervention">Trastuzumab</span> or <span class="go-doc-concept go-doc-intervention">Trastuzumab</span> With <span class="go-doc-concept go-doc-intervention">Pertuzumab</span> in Gastric or Gastroesophageal Junction Adenocarcinoma

Title

  • Brief Title: Neoadjuvant Study Using Trastuzumab or Trastuzumab With Pertuzumab in Gastric or Gastroesophageal Junction Adenocarcinoma
  • Official Title: INtegratioN of Trastuzumab, With or Without Pertuzumab, Into periOperatiVe chemotherApy of HER-2 posiTIve stOmach caNcer: the INNOVATION-TRIAL
  • Clinical Trial IDs

    NCT ID: NCT02205047

    ORG ID: EORTC-1203-GITCG

    NCI ID: 2014-000722-38

    Trial Conditions

    Malignant Neoplasm of Stomach

    Malignant Neoplasm of Cardio-esophageal Junction of Stomach

    Epidermal Growth Factor Receptor (EGFR) Protein Overexpression

    Trial Interventions

    Drug Synonyms Arms
    Cisplatin Standard chemotherapy, Experimental arm 1, Experimental arm 2
    5-fluorouracil or Capecitabine Standard chemotherapy, Experimental arm 1, Experimental arm 2
    Trastuzumab Experimental arm 1, Experimental arm 2
    Pertuzumab Experimental arm 2

    Trial Purpose

    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.

    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.

    Trial Arms

    Name Type Description Interventions
    Standard chemotherapy Active Comparator Cisplatin/capecitabine or cisplatin/5-fluorouracil Cisplatin, 5-fluorouracil or Capecitabine
    Experimental arm 1 Experimental Cisplatin/capecitabine plus trastuzumab or cisplatin/5-fluorouracil plus trastuzumab Cisplatin, 5-fluorouracil or Capecitabine, Trastuzumab
    Experimental arm 2 Experimental cisplatin/capecitabine plus trastuzumab and pertuzumab or cisplatin/5-fluorouracil plus trastuzumab and pertuzumab Cisplatin, 5-fluorouracil or Capecitabine, Trastuzumab, Pertuzumab

    Eligibility 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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Near Complete Pathological Response Rate

    Secondary Outcome Measures

    Locoregional failure

    R0 resection rate

    Distant failure

    Progression-free survival

    Recurrence-free survival

    Overall survival

    Toxicity

    Trial Keywords

    Neoadjuvant chemotherapy