Phase II study for evaluation of volume reduction surgery for Stage IV advanced gastric cancer effectively treated with S-1 based combination chemotherapy
Phase 2
- Conditions
- StageIV gastric cancer
- Registration Number
- JPRN-UMIN000004787
- Lead Sponsor
- PerSeUS-GC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1)History of severe hypersensitivity (allergy) to any medicines 2)Administration contraindication of S-1 and combination agent 3)Continuous use of flucytosine, phenytoin or warfarin potassium 4)Active infection 5)Severe complications, such as intestinal paralysis, ileus, interstitial pneumonitis or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure and hepatic failure 6)Watery stools or diarrhea 7)Massive pleural or abdominal effusion 8)Active double cancer 9)Pregnant or nursing females. 10)Males who are planning partners' pregnancy. 11)Not suitable for participation with any other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of postoperative complications
- Secondary Outcome Measures
Name Time Method overall survival, progression-free survival, histological response, resection rate, response rate