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A Phase III Study of Regional Radiation Therapy in Early Breast CancerUnique Dataset IDnci-data-8ClinicalTrial.gov IDNCT00005957
This dataset will allow users to reproduce the treatment comparison between nodal-irradiation group and the control group in trial NCT00005957.
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. Arm I: Patients undergo standard breast radiotherapy alone 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. Arm II: Patients undergo breast and regional radiotherapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. Radiotherapy in both arms begins as soon as possible after randomization. Radiotherapy must begin within 8 weeks after completion of adjuvant IV chemotherapy, unless radiotherapy is administered concurrently with chemotherapy (i.e., cyclophosphamide, methotrexate, and fluorouracil [CMF]), or within 16 weeks after the last breast surgery for patients treated with hormonal therapy alone.
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-D1-Data-Dictionary.pdf