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

Taiho Pharma

Status and phase: Completed; Phase 3

Conditions: Colorectal Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00152230

01023002

Details and patient eligibility

About

This is a controlled study designed to compare relapse-free survival and overall survival in patients receiving UFT with those in patients receiving surgery alone. Patients will be randomly assigned to surgery alone or surgery followed by UFT within 6 weeks after curative resection. To assess treatment efficacy, 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 12 months after the start of treatment.Evaluations will be separately done for colon cancer and rectal cancer.

Enrollment: 900 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 ≤ 1.2mg/dL
• Renal BUN ≤ 25mg/dL Creatinine ≤ 1.5mg/dL

Exclusion criteria

• Prior anticancer treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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900 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