Trials / Completed
CompletedNCT00152243
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-GC)
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of UFT Compared With Surgery Alone for Serosa-negative Advanced Gastric Cancer (NSAS-GC)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- Sponsor
- Taiho Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a controlled study designed to evaluate the efficacy of UFT on survival compared with surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery followed by UFT within 6 weeks after curative resection. To assess treatment response, data on recurrence and survival will be collected for 5 years after enrollment of the last patient. To evaluate safety, data on adverse events will be collected for 16 months after the start of treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | UFT (uracil, tegafur) | uracil-tegafur 360 mg per square meter per day orally 16 months |
| PROCEDURE | Surgery alone | Gastrectomy of tumour node metastasis(TNM) stage T2N1-2 gastric cancer. |
Timeline
- Start date
- 1997-06-01
- Primary completion
- 2006-03-01
- Completion
- 2007-08-01
- First posted
- 2005-09-09
- Last updated
- 2011-07-07
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT00152243. Inclusion in this directory is not an endorsement.