An open-label multicentre phase IV study of trastuzumab in combination with the standard chemotherapy (as per the routine clinical practice) as first-line therapy in patients with HER2 positive metastatic gastric cancer.
- Conditions
- Health Condition 1: null- HER2 positive metastatic gastric cancer
- Registration Number
- CTRI/2011/10/002087
- Lead Sponsor
- Roche Products India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 30
Adult patients, greater then equal to 18 years of Age
Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with advanced or metastatic disease, not amenable to curative therapy
Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST)
HER2 positive tumor (primary tumor or metastasis
ECOG Performance status 0, 1 or 2
Life expectancy of at least 3 months
Previous chemotherapy for advanced or metastatic disease less than 6 month before study start
Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (patients with partial or total gastrectomy are allowed to participate in the study)
Patients with active (significant or uncontrolled) gastrointestinal bleeding
Residual relevant toxicity resulting from previous chemotherapy
Other malignancy within the last 5 years (except carcinoma in situ of the cervix, or basal cell carcinoma)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Median progression free survival according to tumor assessments <br/ ><br>Timepoint: [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
- Secondary Outcome Measures
Name Time Method Median overall survival <br/ ><br> <br/ ><br>Timepoint: [ Time Frame: 2.5 years ] [ Designated as safety issue: No ] <br/ ><br> <br/ ><br>