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
- 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.
Allocation: Randomized, Primary Purpose: Treatment
Walter F. Van den Bogaert, MD, PhD
United States: Federal Government