Feasibility study of 5-fluorouracil, leucovorin and paclitaxel (FLTAX) in peritoneal disseminated gastric cancer with massive ascites or inadequate oral intake
Not Applicable
- Conditions
- Gastric cancer
- Registration Number
- JPRN-UMIN000002093
- Lead Sponsor
- ational Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
1. Uncontrollable diabetes mellitus 2. Uncontrollable heart disease 3. Other severe complications such as renal failure, liver failure and intestinal pneumonitis 4. Symptomatic CNS metastasis 5. History of hypersensitivity to alcohol 6. Prior taxane-containing chemotherapy 7. Active bacterial or fungous infection 8. Massive pleural effusion 9. Severe diarrhea 10. Active bleeding 11. Active double cancer 12. Pregnancy, the desire to preserve fecundity, or lactating woman 13. Severe mental disorder 14. Patient evaluated to be inadequate by a attending doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part I: Incidence of dose limiting toxicity Part II: Proportion of patients who completed 2 cycles of the protocol treatment
- Secondary Outcome Measures
Name Time Method Adverse events, Response rate, Response for ascites, Overall survival, Progression-free survival, Time to treatment failure