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

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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