PHASE III RANDOMISED TRIAL INVESTIGATING THE ROLE OF INTERNAL MAMMARY AND MEDIAL SUPRACLAVICULAR (IM-MS) LYMPH NODE CHAIN IRRADIATION IN STAGE I-III BREAST CANCER
N/A
75 Years
Female
Breast Cancer
Trial Information
PHASE III RANDOMISED TRIAL INVESTIGATING THE ROLE OF INTERNAL MAMMARY AND MEDIAL SUPRACLAVICULAR (IM-MS) LYMPH NODE CHAIN IRRADIATION IN STAGE I-III BREAST CANCER
OBJECTIVES:
- Compare the effect of irradiation of the homolateral internal mammary and medial
supraclavicular lymph node chains vs no further therapy on survival, disease-free
survival, metastasis-free survival, and cause of death in women with resected stage
I/II/III breast cancer.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating
institution, tumor location, type of prior breast surgery, pathologic T and N stage,
menopausal status, and time sequence of radiotherapy and adjuvant chemotherapy. Patients are
randomized to 1 of 2 arms.
- Arm I: Patients receive no nodal irradiation.
- Arm II: Patients receive irradiation of the internal mammary and medial supraclavicular
lymph node chains delivered at 1 fraction per day, 5 sessions per week, for a total of
25 fractions over 5 weeks. Radiotherapy must begin no later than 8 weeks after surgery.
If adjuvant chemotherapy is given, radiotherapy begins within 6 weeks after the last
course of chemotherapy and within 8 months after surgery.
Patients are followed at least yearly after randomization for up to 20 years.
PROJECTED ACCRUAL: A total of 4,000 patients will be accrued for this study within 4 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed unilateral adenocarcinoma of the breast
- Stage I/II/III (Tx, T0-3, N0-2) disease in one of the following categories or
multifocal tumors if one of the foci is in agreement with the following:
- Centrally or medially located with any lymph node status
- Central location defined as underlying the areola
- Medial location defined as at least partial involvement of upper or lower
medial quadrant of breast
- Externally located with axillary node involvement
- Prior mastectomy or breast-conserving surgery and axillary dissection required
- Sentinel node procedure as axillary intervention without further axillary
surgery is allowed
- No prior internal mammary chain dissection
- No upper inner lesion treated with breast-conserving surgery that precludes
sparing of internal mammary lymph node chain from radiotherapy volume
- Decision at radiation oncologist's discretion
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 75 and under
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Cardiovascular:
- No prior cardiac disease
Other:
- No prior malignancy except adequately treated nonmelanomatous skin cancer or
carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
Other:
- Concurrent enrollment in other randomized trials allowed
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Walter F. Van den Bogaert, MD, PhD
Investigator Affiliation:
U.Z. Gasthuisberg
Authority:
United States: Federal Government
Study ID:
CDR0000065094
NCT ID:
NCT00002851
Start Date:
July 1996
Completion Date:
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- Breast Neoplasms
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