A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-GC)

Taiho Pharma

Status and phase: Completed; Phase 3

Conditions: Gastric Cancer

Treatments: Drug: UFT (uracil, tegafur); Procedure: Surgery alone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00152243

01023003

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 20 to 75
• Performance status 0 , 1, or 2 (ECOG)
• Hematopoietic WBC ≥ 4,000/mm^3 Platelet ≥ 100,000/mm^3
• Hepatic AST and ALT ≤ 2 times upper limit of normal(ULN) Total bilirubin ≤ 1.5 times ULN
• Renal BUN ≤1.5 times ULN Creatinine ≤ 1.5 times ULN

Exclusion criteria

• Prior anticancer treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

500 participants in 2 patient groups

1

Experimental group

Description:

UFT (uracil, tegafur)

Treatment:

Drug: UFT (uracil, tegafur)

2

Other group

Description:

Surgery alone

Treatment:

Procedure: Surgery alone