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

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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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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