Phase III study of cisplatin plus S-1 (CS) compared with docetaxel and cisplatin plus S-1 (DCS) as first-line therapy for advanced gastric cancer(JCOG1013, GC_CS/DCS_P3 ADOPT)
- Conditions
- nresectable or recurrent gastric cancer
- Registration Number
- JPRN-UMIN000007652
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
See the datails via "URL releasing results" above. Also the details can be seen in the JCOG website: http://www.jcog.jp/en/trials/index.html
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 741
Not provided
1) Multiple primary cancers with disease-free period less than 5 years, except carcinoma in situ or intra mucosal disease cured by local therapy 2) Active infection 3) Fever more than 38c 4) Pregnant, unwilling to practice contraception during the study, or lactating female 5) Uncontrolled psychiatry disease 6) Chronic daily treatment with oral or intravenous corticosteroids 7) Uncontrolled diabetes mellitus or chronic daily treatment with insulin 8) Unstable angina, or past history of myocardial infarction in 6 months 9) Evidence of any other serious disease; renal failure, hepatic failure, interstitial pneumonitis or lung fibrosis 10) Active bleeding 11) Massive pleural effusion, more than half of thoracic space at least one-side
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Key secondary endpoint: overall survival in differentiated or undifferentiated adenocarcinoma Other secondary endpoints: progression free survival, response rate, dose intensity, adverse events, grade4 non-hematologic toxicity, early death, toxicity-related death, progression free survival and response rate in differentiated or undifferentiated adenocarcinoma