Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00005957|
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : June 15, 2016
Last Update Posted : April 7, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: Standard Breast Irradiation Radiation: Breast Radiation plus Regional Radiation||Not Applicable|
- 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.
NOTE: * Patients with a negative sentinel node dissection with or without an axillary dissection will be stratified according to the total number of nodes removed
- 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.
Quality of life is assessed (in patients in certain participating centers) within 2 weeks prior to randomization, during the last week of radiotherapy, at 3 and 9 months after completion of radiotherapy, and then annually until first distant disease recurrence.
Cosmetic outcome is assessed (in patients in certain participating centers) within 2 weeks prior to randomization, and then at 3 and 5 years after completion of radiotherapy or until first distant disease recurrence.
Patients are followed at 3, 6, and 9 months, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 1,822 patients will be accrued for this study within approximately 4 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1832 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Study of Regional Radiation Therapy in Early Breast Cancer|
|Actual Study Start Date :||December 14, 1999|
|Actual Primary Completion Date :||November 20, 2014|
|Actual Study Completion Date :||April 19, 2017|
|Active Comparator: Standard Breast Irradiation||
Radiation: Standard Breast Irradiation
Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
Experimental: Breast Radiation plus regional radiation
regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)
Radiation: Breast Radiation plus Regional Radiation
Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.
- Overall Survival [ Time Frame: 10 years ]Duration of study
- Disease-free Survival [ Time Frame: 10 years ]Disease-free survival (including locoregional and distant disease)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005957
|Study Chair:||Timothy J. Whelan, MD||Margaret and Charles Juravinski Cancer Centre|
|Study Chair:||David S. Parda||Allegheny Cancer Center at Allegheny General Hospital|
|Study Chair:||Julia R. White, MD||Medical College of Wisconsin|
|Study Chair:||Lori J. Pierce, MD||University of Michigan Rogel Cancer Center|
|Study Chair:||Boon Chua, MD||Peter MacCallum Cancer Centre, Australia|
|Study Chair:||Laura A. Vallow, MD||Mayo Clinic|