A phase ll study to show the feasibility of six months continuous administration of Docetaxel+TS-1 for patients with Stage lllA/lllB gastric cancer after surgical resection (OGSG 1002)
- Conditions
- gastric cancer
- Registration Number
- JPRN-UMIN000004440
- Lead Sponsor
- Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
- Brief Summary
The completion rate for eight cycles of S-1 plus docetaxel(DS) therapy was 77.4% [95% confidence interval (CI) 65.0-87.1%]. Subsequent S-1 monotherapy for 1 year was feasible in 71.0% (95% CI 58.1-81.8%) of patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 62
Not provided
1)Patients with double cancers (simultaneous or different time) Following cases are eligeble : 1.carcinoma in situ of cervical cancer and/or focal colon cancer in adenoma 2.small multiple cancers whose stages are lower than main cancer 3.double early cancers removed by EMR/EDS 2)patients who has contraindication to TS-1 3)patients who need Flucitosine,Fenitoin and/or Walfarin 4)patients who have a history of severe allergy against medicine in grade 3 or 4 5)patients who have a history of severe allergy against medicine including polysolvate 80 6)with interstitial pneumonia 7)with severe diseases(intestinal paralysis, ileus, uncontrollable DM, Cardiac failure, liver dysfunction) 8)with watery diarrhea 9)Females who are pregnent,nursing or possibility of pregnancy, or have a plan to have baby in future 10)Males who have a plan to have their own baby 11)with HIV (positive) or liver cirrhosis/active hepatitis 12)Edema which needs treatment 13)patients whom doctor in chief decides not to register to this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method six months durability rate of TS-1 administration
- Secondary Outcome Measures
Name Time Method Overall survival, Deasease-free survival, Advers events, Twelve months durability of TS-1 administration