This phase II trial studies the side effects and how well radiation therapy works in treating patients with stage 0-II breast cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PRIMARY OBJECTIVES: I. To assess the cosmesis, acute toxicity and late toxicity in patients treated with accelerated partial breast irradiation delivered with proton radiation. SECONDARY OBJECTIVES: I. To evaluate the convenience of accelerated partial breast irradiation and quality of life during accelerated partial breast irradiation. II. To estimate the in-breast tumor control rates in patients treated with accelerated partial breast irradiation delivered with proton radiation. III. Compare dosimetry to alternate treatment modalities. OUTLINE: Within 10 weeks of last breast cancer surgery, patients undergo accelerated partial breast irradiation (APBI) delivered with proton radiation twice daily (BID) for 5 days. After completion of study treatment, patients are followed up at 6 weeks, 6 months, 1 year, and 18 months, then annually for 10 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Undergo APBI delivered with proton radiation
Undergo APBI delivered with proton radiation
Ancillary studies
M D Anderson Cancer Center
Houston, Texas, United States
Patient-Reported Cosmesis Score
Patient-reported cosmesis score on the Breast Cancer Treatment Outcomes Scale (BCTOS) at 1 year. Cosmesis scores range from 1 (excellent) to 4 (poor), and scores of 3 (fair) or more indicate adverse cosmetic outcomes.
Time frame: 1 year
Rate of CTCAE Grade 3+ Confluent Moist Desquamation
Rate of CTCAE grade 3+ confluent moist desquamation estimated within 6 weeks of radiation therapy with a 90% credible interval. If we observe CTCAE grade 3+ confluent moist desquamation in only 20 patients, then our 90% credible interval will be 7% to 13%.
Time frame: Within 6 weeks of radiation therapy
Percent of Patients with Local Failure
Percent of patients with local failure at 10 years estimated with an exact 95% confidence interval. If there is 1 patient with local failure at 10 years, and researchers have follow-up on all patients at 10 years, then the upper limit of the exact 95% confidence interval will be 2.8%. If researchers don't have 10 years of follow-up on all patients researchers will use the product-limit estimator of Kaplan and Meier (1958) to estimate the local failure rate at 10 years.
Time frame: 10 years
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