A Phase 3 interventional study of CAF regimen and CMF regimen in Breast Cancer, sponsored by Grupo Oncologico Cooperativo del Sur. Suspended at 7 sites in Argentina. Open to female participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-08-02.
Sponsored by Grupo Oncologico Cooperativo del Sur · Phase 3, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare cyclophosphamide, doxorubicin, and fluorouracil with cyclophosphamide, methotrexate, and fluorouracil in treating women with stage III breast cancer.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center.
Patients on both arms with resectable disease after the third course of chemotherapy undergo quadrantectomy with axillary node dissection (preferred) or modified radical mastectomy, followed by 6 additional courses of chemotherapy on the arm to which they were randomized initially. Those patients without distant metastasis undergo locoregional radiotherapy beginning concurrently with the initiation of postoperative chemotherapy. Patients on both arms with unresectable disease after the initial 3 courses of chemotherapy undergo locoregional radiotherapy and then surgical resection (if feasible).
Quality of life is assessed at baseline and then monthly thereafter.
Patients are followed every 3-4 months for 2 years, every 4-6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Not specified
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
Browse Breast Neoplasms studies →Grupo Oncologico Cooperativo del Sur is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
This study is suspended, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.
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Grupo Oncologico Cooperativo del Sur