A Phase II study of capecitabine plus cisplatin (plus trastuzumab) for previously untreated advanced gastric cancer.
Phase 2
- Conditions
- untreated advanced gastric cancer
- Registration Number
- JPRN-UMIN000005998
- Lead Sponsor
- Department of Digestive surgery, Kawasaki Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 53
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Forbidden case to use capecitabine and/or cisplatin (2) Infection or inflammatory case (3) Severe heart disease (4) Severe complicated case such as ileus, interstitial pneumonia, uncontrolled DM, liver cirrhosis etc (5) a lot of ascites (6) many bone metastasis (7) brain metastasis (8) repeated gastrointestinal bleeding (9) severe psychological disease (10) complicated other active cancer (11) pregnant or intended to be pregnant (12) intend to make pregnant (13) others
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PFS: Progression Free Survival
- Secondary Outcome Measures
Name Time Method ORR: Overall Response Rate DCR: Disease Control Rate OS: Overall Survival The safty and efficacy of the biomarker; TP/DPD, HR, ER, PgR status