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A Phase III Study of Regional Radiation Therapy in Early Breast CancerUnique Data Set IDnci-data-18
Clinical Trial Title
A Phase III Study of Regional Radiation Therapy in Early Breast Cancer
Trial Summary and Conditions
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation to the tumor site and surrounding area may kill more tumor cells. It is not yet known if radiation therapy to the breast alone following surgery is more effective than radiation therapy to the breast plus surrounding tissue in treating invasive breast cancer. PURPOSE: This randomized phase III trial is studying radiation therapy to the breast alone to see how well it works compared to radiation therapy to the breast plus surrounding tissue in treating women who have undergone surgery for early-stage invasive breast cancer.
See data dictionary for more details.
OBJECTIVES: Compare the overall survival, disease-free survival, isolated local regional disease-free survival, and distant disease-free survival in women with previously resected, early stage, invasive breast cancer treated with breast radiotherapy with or without regional radiotherapy. Compare the toxic effects of these regimens in these patients. Compare the quality of life of patients (in certain participating centers) treated with these regimens. Compare the cosmetic outcomes in patients (in certain participating centers) treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of positive nodes (0 vs 1-3 vs more than 3), number of axillary nodes removed (<10, > or equal to 10); type of chemotherapy (anthracycline containing vs other vs none), hormonal therapy (yes vs no), number of axillary lymph nodes excised*, and participating center. Patients are randomized to one of two treatment arms.
Primary: Overall Survival [ Time Frame: 10 years ] Secondary: Disease-free Survival [ Time Frame: 10 years ]
Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):
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Data Dictionary: NCT00005957-D3-Data-Dictionary.pdf