Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With Active Breathing Coordinator
50 left sided breast cancer patients will be randomized to receive breast/chest wall
irradiation with or without ABC. Patients will receive radiation therapy at a dose of
180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional
radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating
physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy.
Treatments will be given Monday through Friday.
After the completion of radiation therapy, patients will be seen on the following schedule:
A follow up examination will take place every 3-6 months for the first two years, then every
4-6 months for years for the next 3 years. After 5 years follow-up evaluations will occur
annually. A SPECT scan will be obtained at 6 months post therapy.
Patients must be 18 and older and must have histologically confirmed (by routine H&E
staining) invasive adenocarcinoma or Ductal Carcinoma In Situ of the left breast.
Patients must have also undergone a segmental mastectomy (SM) or Mastectomy.
Patients must not have received prior radiation therapy to the breast at any time for any
Patients must not be pregnant due to the potential for fetal harm as a result of this
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Test the efficacy of the ABC device in protecting the heart from radiation damage in patients with L breast cancer.
Richard Zellars, M.D.
Sidney Kimmel Comprehensive Cancer Center- Dept. Radiation Oncology
United States: Food and Drug Administration
|The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231|