In the setting of radiotherapy as part of breast-conservation therapy for patients with early stage breast cancer, the novel planning and delivery method of intensity modulated radiotherapy is an effective and safe alternative to the commonly-used standard 3D-conformal external beam radiotherapy, spares more normal breast and lung tissue, and may lead to improved clinical outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
660
38.5 Gy, 10 fractions over 5 days
38.5 Gy, 10 fractions over 5 days
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States
RECRUITINGRocky Mountain Cancer Centers - Boulder
Boulder, Colorado, United States
RECRUITINGRocky Mountain Cancer Centers - Lakewood
Lakewood, Colorado, United States
RECRUITINGRocky Mountain Cancer Centers - Littleton
Littleton, Colorado, United States
RECRUITINGRocky Mountain Cancer Centers - Thornton
Thornton, Colorado, United States
RECRUITINGPrevalence of breast pain after Accelerated Partial Breast Radiotherapy (APBI)
Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit
Time frame: 5 years
Prevalence of chest wall pain after Accelerated Partial Breast Radiotherapy (APBI)
Assessment by both treating investigators and by subjective patient outcomes questionnaires filled out at each follow-up visit
Time frame: 2-5 years
Dosimetric comparison
Comparison of treatment plans and actual doses received between comparable patients treated with 3D-CRT and IMRT with regard to treatment target and normal tissue
Time frame: 5-10 days
Acute skin reactions
Radiation-induced dermatitis
Time frame: 6 months
Cosmetic outcomes after APBI
Assesed by both treating investigators and subjective patient questionnaires filled out at each follow-up visit
Time frame: 2-5 years
Ipsilateral breast event
Track occurrence and patterns of local treatment failures or new primaries within the treated breast (efficacy outcome measure)
Time frame: 5-15 years
Cause specific survival
Track survival status and the specific cause(s) of death if applicable for study participants (efficacy outcome measure)
Time frame: 5-15 years
Disease free survival
Track breast-cancer free survival status of study participants (efficacy outcome measure)
Time frame: 5-15 years
Overall survival
Track the overall survival status of all study participants (efficacy outcome measure)
Time frame: 5-15 years
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