A Phase III Study of Regional Radiation Therapy in Early Breast Cancer
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.
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.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival
Duration of study
13 years
No
Timothy J. Whelan, MD
Study Chair
Margaret and Charles Juravinski Cancer Centre
Canada: Health Canada
MA20
NCT00005957
April 2000
July 2014
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