Trial | NCT00152191  Report issue

Title

A Randomized Controlled Study of Postoperative Adjuvant Therapy of Uracil-tegafur (UFT) Compared With Cyclophosphamide/Methotrexate/5-fluorouracil (CMF) in Breast Cancer (NSAS-BC)
A Randomized Controlled Study of Postoperative Adjuvant Therapy of UFT Compared With CMF in High-risk Women With Axillary Node-negative Breast Cancer (NSAS-BC)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    1300
This is a randomized controlled study designed to evaluate the relapse-free survival of the UFT group compared with the CMF group. Patients will be randomly assigned to receive either CMF or UFT within 12 weeks after curative resection. To evaluate treatment efficacy, data on recurrence, and survival will be collected for up to 10 years after enrollment of the final patient. To assess safety, data on adverse events will be collected for 2 years after the start of treatment. Patients'quality of life will be assessed by means of a questionnaire.
Study Started
Oct 31
1996
Primary Completion
Oct 31
2007
Study Completion
Jan 31
2008
Last Update
Jul 07
2011
Estimate

Drug UFT (uracil, tegafur)

uracil, tegafur was orally administered by 300 mg per square meter per day for 2 years

Drug cyclophosphamide, methotrexate, and fluorouracil

cyclophosphamide:100 mg, po, day 1-14 methotrexate:40 mg/m2, day 1, 8 q28 days x 6 cycles fluorouracil:500 mg/m2, day 1, 8

1 Experimental

UFT (uracil, tegafur)

2 Active Comparator

CMF(cyclophosphamide, methotrexate, and fluorouracil)

Criteria 

Inclusion Criteria:

Age 18 to 75
Performance status 0 or 1 (ECOG)
Hematopoietic WBC ≥ 4,000/mm^3 Platelet ≥ 100,000/mm^3
Hepatic AST and ALT ≤ 2.5 times upper limit of normal(ULN) Total bilirubin ≤ ULN
Renal Creatinine ≤ ULN

Exclusion Criteria:

Prior anticancer treatment
No Results Posted