The goal of this study is to evaluate 5 days vs. 9 days of whole breast radiation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
144
Undergo hypofractionated radiation therapy
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
RECRUITING24-month Mean breast overall satisfaction Breast - Q scores with 5 fractions of radiation is non-inferior in patient reported outcomes.
To evaluate non-inferiority of 24-month Breast-Q satisfaction with breast score with 5 versus 9 fractions of radiation.
Time frame: 3 years
Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by type
To estimate the incidence of acute and late radiation complications between the two arms, based on CTCAE 5.0 toxicity.
Time frame: 5 years
Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by severity (as defined by the NIH CTCAE, version 5.0)
To estimate the incidence of acute and late radiation complications between the two arms, based on CTCAE 5.0 toxicity.
Time frame: 5 years
Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by seriousness
To estimate the incidence of acute and late radiation complications between the two arms, based on CTCAE 5.0 toxicity.
Time frame: 5 years
Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by duration
To estimate the incidence of acute and late radiation complications between the two arms, based on CTCAE 5.0 toxicity.
Time frame: 5 years
Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by relationship to study treatment.
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To estimate the incidence of acute and late radiation complications between the two arms, based on CTCAE 5.0 toxicity.
Time frame: 5 years
Evaluate non-inferiority of local and local regional recurrence rate in the treatment arms.
To evaluate non-inferiority of the local and local regional recurrence rate between the two arms.
Time frame: 8 years
Evaluate non-inferiority of a change in cosmetic scores in the treatment arms with pre-radiation scores to post 24-month scores using the UK photographic assessment and EORTC scales.
To evaluate non-inferiority of the breast photographic cosmetic outcomes of the UK and EORTC scales
Time frame: 5 years
60-month mean breast overall satisfaction Breast-Q scores with 5 fractions of radiation is non-inferior in patient reported outcomes.
To evaluate non-inferiority of the mean Breast-Q scores with 5 fractions of radiation at 60 months.
Time frame: 5 years