Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer
Phase 3
Completed
- Conditions
- Gastric Cancer
- Registration Number
- NCT00195572
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Brief Summary
The purpose of the study is to verify non-inferiority of survival time between Isovorin/5-fluorouracil (1-LV/5FU) therapy and TS-1 therapy in patients with inoperable advanced or recurrent gastric cancer. Secondary endpoints include response rates, duration of responses, time to progression (TTP) safety and quality of life (QOL).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Gastric cancer diagnosed histologically or cytologically
- Normal organ function of bone marrow, heart, liver and kidney
- Age of 20-77
Other inclusion applies
Exclusion Criteria
- Serious infection, heart disease, complication or organ disorder
- Ongoing administration of flucytosine
- Pregnant or breastfeeding women
Other exclusion applies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Survival time
- Secondary Outcome Measures
Name Time Method Response rate, duration of response, time to progression, safety, quality of life