Trials / Completed
CompletedNCT00152217
Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer (ACTS-GC)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,000 (estimated)
- Sponsor
- Taiho Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This controlled study is designed to evaluate the efficacy of TS-1 on survival compared with surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery followed by treatment with TS-1 within 45 days after curative resection (curability A or B). To assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 5 years after surgery. To evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TS-1 (S-1) | 80 mg of oral S-1 per square meter of body-surface area per day was given for 4 weeks and no chemotherapy was given for the following 2 weeks |
| PROCEDURE | Surgery | Stage II or III gastric cancer who underwent gastrectomy were assigned to surgery only |
Timeline
- Start date
- 2001-09-01
- Primary completion
- 2007-05-01
- Completion
- 2010-12-01
- First posted
- 2005-09-09
- Last updated
- 2011-07-07
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT00152217. Inclusion in this directory is not an endorsement.