Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer

Wyeth

Status and phase: Completed; Phase 3

Conditions: Gastric Cancer

Treatments: Drug: TS-1; Drug: Isovorin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00195572

ISO/5FU-10

Details and patient eligibility

About

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).

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 77 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)