Randomized phase II study comparing S-1 plus oxaliplatin with S-1 monotherapy for elderly patients with advanced gastric cancer.(WJOG8315G)
- Conditions
- advanced gastric cancer.
- Registration Number
- JPRN-UMIN000020864
- Lead Sponsor
- West Japan Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 160
Not provided
1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma. 2) Active infection under treatment 3) Peripheral sensory neuropathy of grade >= 2 according to NCI-CTCAE version 4.0. 4) Diarrhea of grade >= 2 according to NCI-CTCAE version 4.0. 5) Pulmonary fibrosis or interstitial pneumonitis detected by chest x-ray. 6) Receiving flucytosine 7) Receiving phenytoin or warfarin potassium 8) Current treatment with corticosteroids. 9) Pregnant or lactating female. 10) Uncontrolled psychiatry disease 11) History of serious allergic reactions. 12) Evidence of any other serious disease, e.g. COPD, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled cardiovascular disease, Cerebral infarction within one year, active gastrointestinal hemorrhage, blood tests positive for HBs antigen or HVC antibody. 13) Judged inappropriate by the investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival
- Secondary Outcome Measures
Name Time Method progression free survival,time to treatment failure,response rate,safety