Safety and Feasibility of Accelerated, Hypofractionated Radiotherapy in Women With Breast Cancer: A Phase II Trial
- To determine the freedom from local and regional failure in women with early stage
breast cancer treated with accelerated, hypofractionated radiotherapy.
- To determine the acute and late toxicity of accelerated, hypofractionated radiotherapy
using previously published toxicity scales.
- To measure cosmesis using the Harvard cosmesis scale in patients who have undergone
- To identify co-variates responsible for poor cosmetic outcome in these patients.
OUTLINE: Patients who have undergone lumpectomy undergo either intracavitary balloon
brachytherapy boost and hypofractionated, accelerated whole breast irradiation (AWBI) OR
3D-conformal radiotherapy (3D-CRT)/intensity-modulated radiotherapy (IMRT) boost and AWBI.
Patients who have undergone mastectomy undergo hypofractionated, accelerated chest wall
- Intracavitary balloon brachytherapy boost and AWBI (post-lumpectomy): Patients undergo
intracavitary balloon brachytherapy boost twice daily for 2 days (total of 4
fractions). Beginning 5-21 days after completion of brachytherapy, patients undergo
AWBI once daily 5 days a week for approximately 2 weeks (total of 11 fractions).
- 3D-CRT/IMRT boost and AWBI (post-lumpectomy): Patients undergo 3D-CRT/IMRT boost twice
daily for 2 days (total of 4 fractions). Patients also undergo AWBI as above before or
after boost radiotherapy.
- Accelerated chest wall irradiation (post-mastectomy): Patients undergo accelerated
chest wall irradiation once daily 5 days a week for approximately 2 weeks (total of 11
Patients who have undergone lumpectomy undergo frontal digital photography of the breasts at
baseline, immediately before the initiation of radiotherapy, and then annually for 3 years
after completion of radiotherapy. These patients also complete the Breast Cancer Treatment
Outcome Scale at baseline and at 3 years after completion of radiotherapy. Physicians
complete the Harvard Cosmesis scale at baseline and at 1 and 3 years after completion of
After completion of study treatment, patients are followed up at weeks 1, 4, and 8 and then
every 4 months for 2 years, every 6 months for 3 years, and annually thereafter.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Loco-regional control as assessed by physical examination, mammography, and other relevant imaging
Atif Khan, MD
Cancer Institute of New Jersey
United States: Institutional Review Board
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||New Brunswick, New Jersey 08903|