Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
National Cancer Institute of Canada National Cancer Institute (NCI) National Surgical Adjuvant Breast and Bowel Project (NSABP) Radiation Therapy Oncology Group Southwest Oncology Group Trans-Tasman Radiation Oncology Group (TROG) North Central Cancer Treatment Group |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005957 |
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 | Intervention | Phase |
---|---|---|
Breast Cancer |
Procedure: adjuvant therapy Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III Study of Regional Radiation Therapy in Early Breast Cancer |
Estimated Enrollment: | 1822 |
Study Start Date: | April 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of positive nodes (0 vs 1-3 vs more than 3), 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
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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven invasive carcinoma of the breast
Prior breast-conserving therapy (BCT) (e.g., lumpectomy, partial mastectomy, or segmental mastectomy) and axillary node dissection or sentinel node biopsy required and must be a candidate for breast radiotherapy after BCT
Patients with prior sentinel node dissection eligible if node negative, but still meet high-risk criteria
High risk of regional and systemic recurrence due to one of the following:
Pathologically negative axillary lymph nodes with one of the following:
Primary tumor greater than 2 cm and less than 10 axillary lymph nodes excised and one of the following:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
No other malignancy except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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 Cancer Center |
Study Chair: | Boon Chua, MD | Peter MacCallum Cancer Centre, Australia |
Study Chair: | Laura A. Vallow, MD | Mayo Clinic |
Study ID Numbers: | CDR0000067938, CAN-NCIC-MA20, NSABP-CAN-NCIC-MA20, NCCTG-CAN-NCIC-MA20, RTOG-CAN-NCIC-MA20, SWOG-CAN-NCIC-MA20, TROG-CAN-NCIC-MA20 |
Study First Received: | July 5, 2000 |
Last Updated: | December 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00005957 |
Health Authority: | United States: Federal Government |
stage I breast cancer stage II breast cancer |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |