Phase II study of Docetaxel, Cisplatin and S1 followed by surgery in advanced gastric cancer with lymph node metastasis of the paraaorta
Phase 2
Recruiting
- Conditions
- gastric cancer with para-aortic lymph node metastasis
- Registration Number
- JPRN-UMIN000006036
- Lead Sponsor
- Digestive Disease Support Organization (DDSO)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patient with clinically obvious infecton 2) Serious complications(cardiac disease, respiratory dysfunction, bleeding disorder, severe HT or DM) 3) Gastric remnant cancer 4) Synchronous or metachronous malignancy in other organs including 5-year disease-free survival 5) Gastric cancer wtih distant metastasis 6) Past history of drug allergy of docetaxel or CDDP or S-1 7,8) Difficulty to join the trial due to psychosis or psychotic symptoms or central nervous system damage 9) Probable pregnancy, and the period of lactation 10)Not fit to the protocol treatment by the physicion's dicision
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method histological response of para-aortic lymph node in preoperative chemotherapy
- Secondary Outcome Measures
Name Time Method proportion of completion of treatment, proportion of curative resection, response rate(RECISTv.1.0), 3-year survival, proportion of toxicities, proportion of treatment related death