Not Signed In -
Methotrexate |
Rheumatrex; Trexall |
Clinical Trial: A Randomized Controlled Study of Postoperative Adjuvant Therapy of UFT Compared with CMF in Breast Cancer (NSAS-BC)
This study is no longer recruiting patients.
|
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Breast Cancer | Drug: UFT (uracil, tegafur) Drug: cyclophosphamide, methotrexate, and fluorouracil | Phase III |
MedlinePlus related topics: Breast Cancer
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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)
Further Study Details:
Primary Outcomes: Relapse-free survival
Secondary Outcomes: Overall survival, adverse events, and the quality of life
Expected Total Enrollment: 1300
Secondary Outcomes: Overall survival, adverse events, and the quality of life
Expected Total Enrollment: 1300
Study start: October 1996; Study completion: March 2012
Last follow-up: March 2011; Data entry closure: September 2011
Eligibility
Ages Eligible for Study: 18 Years - 75 Years, Genders Eligible for Study: Female
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
Location Information
Study chairs or principal investigators
Toru Watanabe, MD, Principal Investigator, Hamamatsu Oncology Center
More Information
Study ID Numbers: 01023001
Last Updated: September 12, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00152191
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 12, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00152191
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Methotrexate (Drug Digest)
- Methotrexate (Cleveland Clinic)
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