Randomized phase II/III study of 5-fluorouracil /l-leucovorin vs. 5-fluorouracil /l-leucovorin plus paclitaxel in gastric cancer with severe peritoneal metastasis (JCOG1108/WJOG7312G, abbreviation:GC_FL/FLTAX_P2/3)
Phase 2
Completed
- Conditions
- Gastric cancer
- Registration Number
- JPRN-UMIN000010949
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 330
Inclusion Criteria
Not provided
Exclusion Criteria
1) Other currently active malignancies excluding malignancies that are disease free for more than 5 years or carcinoma-in -situ deemed cured by adequate treatment 2) Active infection 3) Body temperature >= 38 degrees Celsius 4) Pregnant of lactating female 5) Psychiatric disease that is inappropriate for entry into this study 6) Continuous systemic steroids 7) Uncontrolled diabetes despite routine administration of insullin 8) Myocardial infarction within the last 6 months, unstable angina pectoris within the last 3 weeks 9) History of any medical condition including renal insufficiency, liver insufficiency, and interstitial pneumonitis 10)Active bleeding 11) HBs Ag: positive, HCV Ab: positive
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method