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Phase III Randomized Study of Adjuvant Breast Radiotherapy With or Without Regional Radiotherapy in Women With Previously Resected, Early Stage, Invasive Breast Cancer
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
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Phase III | Treatment | Closed | 16 and over | CAN-NCIC-MA20 NSABP-CAN-NCIC-MA20, NCCTG-CAN-NCIC-MA20, RTOG-CAN-NCIC-MA20, SWOG-CAN-NCIC-MA20, TROG-CAN-NCIC-MA20, NCIC-MA20, NCT00005957, MA20 |
Special Category:
CTSU trial 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.
Entry Criteria Disease Characteristics:
- Histologically proven invasive carcinoma of the breast
- No evidence of T4, N2-3, or M1 disease prior to
surgery
- Node positive or high-risk node negative
- 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
- Normally patients should have microscopically clear
resection margins and
those with positive margins should undergo reexcision
- Patients with microscopically focally positive margins
(defined as no greater than 3 times high power fields) are candidates for
breast radiotherapy plus a boost to the lumpectomy site
- Patients with prior sentinel node dissection eligible
if node negative, but
still meet high-risk criteria
- If node positive, then a level I and II axillary
dissection must be performed
- No evidence of residual disease in axilla after
dissection
- Must be treated with currently accepted adjuvant systemic chemotherapy
and/or
hormonal therapy
- High risk of regional and systemic recurrence due to one of the
following:
- Pathologically positive axillary lymph nodes
- Pathologically negative axillary lymph nodes with one
of the following:
- Primary tumor greater than 5 cm
- Primary tumor greater than 2 cm and less than 10
axillary lymph nodes
excised and one of the following:
- Estrogen receptor negative
- Skarf-Bloom-Richardson grade 3
- Lymphovascular invasion
- Hormone receptor status:
- Estrogen and progesterone receptor status known
Prior/Concurrent Therapy:
Biologic therapy: Chemotherapy: - See Disease Characteristics
- Concurrent standard adjuvant chemotherapy allowed
Endocrine therapy: - See Disease Characteristics
- Concurrent standard adjuvant hormonal therapy allowed
Radiotherapy: - See Disease Characteristics
Surgery: - See Disease Characteristics
Patient Characteristics:
Age: Sex: Menopausal status: - Premenopausal or postmenopausal
Performance status: Life expectancy: Hematopoietic: Hepatic: - SGOT and/or SGPT no greater than 3 times upper limit of normal
(ULN)*
- Alkaline phosphatase no greater than 3 times ULN*
[Note: * Patients with laboratory values greater than 3 times ULN may
still be eligible if no metastatic disease by imaging
examinations] Renal: - No serious nonmalignant renal disease
Cardiovascular: - No serious nonmalignant cardiovascular disease
Pulmonary: - No serious nonmalignant pulmonary disease
Other: - Not pregnant or nursing
- Fertile patients must use effective contraception
- No other serious nonmalignant disease (e.g., systemic lupus
erythematosus or scleroderma) that would preclude definitive surgery or
radiotherapy
- No other malignancy except:
- Nonmelanomatous skin cancer
- Carcinoma in situ of the cervix or endometrium
- Contralateral noninvasive breast cancer (unless prior radiotherapy to the contralateral breast)
- Invasive carcinoma of the cervix, endometrium, colon,
thyroid, or melanoma that was curatively treated at least 5 years prior to study participation
- No psychiatric or addictive disorder that would preclude
informed consent or study compliance
Expected Enrollment 1822Approximately 1,822 patients will be accrued for this study within
approximately 4 years. Outcomes Primary Outcome(s)Overall survival
Secondary Outcome(s)Disease-free survival (including locoregional and distant disease) Toxicity assessed by NCI CTC v2.0 Quality of life assessed by the EORTC QLQ-C30, OCOG Breast Cancer Questionnaire Cosmetic outcome according to the EORTC Breast Cancer Rating System for Cosmetic Results of Breast Conserving Treatment
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] - 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.
Trial Contact Information
Trial Lead Organizations NCIC-Clinical Trials Group | | | Timothy Whelan, MD, Protocol chair | | Ph: 905-387-9711 ext. 64509 |
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National Surgical Adjuvant Breast and Bowel Project | | | David Parda, Protocol chair | | | |
Radiation Therapy Oncology Group | | | Julia White, MD, Protocol chair | | | |
Southwest Oncology Group | | | Lori Pierce, MD, Protocol chair | | Ph: 734-764-9922; 800-865-1125 |
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Trans-Tasman Radiation Oncological Group Incorporated | | | Boon Chua, MD, Protocol chair | | | |
North Central Cancer Treatment Group | | | Laura Vallow, MD, Protocol chair | | | |
Registry Information | | Official Title | | A Phase III Study of Regional Radiation Therapy in Early Breast Cancer | | Trial Start Date | | 2000-04-27 | | Registered in ClinicalTrials.gov | | NCT00005957 | | Date Submitted to PDQ | | 2002-08-02 | | Information Last Verified | | 2007-02-01 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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