Randomized phase III trial of surgery plus neoadjubant TS-1 and cisplatin compared with surgery alone for type 4 and large type 3 gastric cancer: Japan Clinical Oncology Group Study (JCOG 0501)
Phase 3
- Conditions
- gastric neoplasm
- Registration Number
- JPRN-C000000279
- Lead Sponsor
- Japan Clinical Oncology Group(JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 316
Inclusion Criteria
Not provided
Exclusion Criteria
(1) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ (2) pregnant or breast-feeding women (3) severe mental disease (4) systemic administration of corticosteroids, flucytosine, phenytoin or warfarin (5) other severe complications such as paralytic ileus, intensitinal pneumonitis, pulumonary fibrosis, or ischemic heart disease (6) myocardial infarction within six disease-free months (7) positive HBs antigen
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 (PFS), response rate, proportion of protocol achievement, proportion of curative resection, and adverse events. In this trial, curative resection means R0 resection (TNM classification) with more than D2 dissection.