After Mapping Of The Axilla: Radiotherapy Or Surgery
- Compare the regional control of the axilla obtained by complete axillary lymph node
dissection vs axillary radiotherapy in sentinel lymph node-positive women with operable
invasive breast cancer.
- Determine whether local and regional axillary control can be obtained without axillary
lymph node dissection in sentinel lymph node-negative women.
- Compare the axillary 5-year recurrence-free survival of these patients treated with
- Compare the morbidity of patients treated with these regimens.
- Compare the quality of life of these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center and type of breast surgery (conservation vs total mastectomy). Patients
are randomized to 1 of 2 treatment arms.
Patients are given an injection of a tracer and undergo lymphoscintigraphy 2-3 hours later
to identify the sentinel lymph node. Within 24 hours after lymphoscintigraphy, patients
undergo wide local excision of the tumor or mastectomy after the sentinel node is removed.
If no sentinel node is found or metastasis is found in a nonsentinel node, patients undergo
complete axillary lymph node dissection (ALND) regardless of randomization. Sentinel
node-negative patients receive no further treatment. Sentinel node-positive patients
continue treatment according to randomization.
- Arm I: Within 8 weeks after surgery, patients undergo complete ALND.
- Arm II: Within 8 weeks after surgery, patients undergo axillary lymph node radiotherapy
daily 5 days a week for 5 weeks.
Patients in arm I may receive postoperative axillary irradiation if 4 or more nodes are
positive and more than 1 axillary level is involved.
Quality of life is assessed at baseline and then at 1, 2, 3, and 5 years.
Patients are followed annually for 5 years.
PROJECTED ACCRUAL: A total of 3,485 patients (1,394 sentinel node-positive and 2,091
sentinel node-negative) will be accrued for this study within 3 years.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Axillary recurrence rate
Emiel JT Rutgers
The Netherlands Cancer Institute
United States: Federal Government