Accelerated, Hypofractionated Post-Mastectomy Radiation Therapy in Women With Breast Cancer: A Phase II Trial
I. Freedom from local failure and freedom from regional failure.
I. Acute toxicity and late toxicity using previously published toxicity scales. II. To
identify co-variates responsible for poor cosmetic outcome in women with reconstructed chest
walls when treated with accelerated, hypofractionated radiotherapy.
III. To correlate toxicity, cosmesis, and local control with molecular markers.
Patients undergo hypofractionated accelerated RT over 11 weekdays (for 15 elapsed days)
within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 2-8 weeks, every 3-6 months
for 3 years, every 6-12 months for 2 years, and then annually thereafter.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to local, regional, and/or distant failure
Assessed by physical examination and other relevant imaging per the discretion of the patients treating physicians. Confirmed by biopsy, and should be coded as either chest wall recurrence, axilla, supraclavicular, or internal mammary.
Up to 5 years after dose of last treatment
Atif Khan, MD
Cancer Institute of New Jersey
United States: Food and Drug Administration
|Cancer Institute of New Jersey||New Brunswick, New Jersey 08901|