Phase II Study of Docetaxel and S-1 Combination Therapy for Advanced or Recurrent Gastric Cancer
Phase 2
- Conditions
- Metastatic gastric cancer (Advanced or recurrent gastric cancer)
- Registration Number
- JPRN-C000000103
- Lead Sponsor
- Hiroshima Cancer Therapy Development Organization (HiCTDO)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1)Symptomatic infectious disease 2)Accompanied serious diseases such as pulmonary fibrosis, interstitial pneumonia, and symptomatic bleeding tendency 3)Peripheral neuropathy>=grade 2 4)Edema>=grade 2 5)Active secondary cancer 6)Symptomatic pleural effusion or ascites 7)Pregnancy or breast feeding 8)Obstructive bowel disease 9)Concomitant therapy with another anticancer drug or flucytocine 10)Past history of allergic reaction to polysorbate 80 11)A past history of drug allergy 12)A past history of allergic reaction to alcohol 13)Symptomatic psychological disease, or uncontrollable diabetes 14)Hemorrhage/bleeding>=grade 3 (NCI-CTC) 15)Decision as ineligible by principal investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tumor response rate
- Secondary Outcome Measures
Name Time Method 1)Adverse events, 2)Progression free-survival (PFS) 3)Median overall survival (MST)