Trials / Completed
CompletedNCT00195572
Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer
Post-Approved Phase III Study of 1-LV/5FU Therapy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer · Industry
- Sex
- All
- Age
- 20 Years – 77 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Isovorin | |
| DRUG | TS-1 |
Timeline
- Start date
- 2002-05-01
- Primary completion
- 2008-08-01
- Completion
- 2008-08-01
- First posted
- 2005-09-19
- Last updated
- 2009-08-13
Locations
43 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00195572. Inclusion in this directory is not an endorsement.