A Phase II Study of Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer (MAPBI)
Summary
This trial will investigate a novel 3-fraction radiation regimen for participants undergoing breast-conserving therapy (BCT) for early breast cancer that will: 1) significantly reduce the duration of treatment and can be completed in one-week (5 working days) and 2) MRI-guided radiotherapy (MRIdian) would limit the volume of normal tissue radiated and therefore resultant toxicity. The hypothesis is that 3-fraction radiation therapy can be delivered safely without compromising the therapeutic ratio. Participants can expect to be on study for follow up up to 5 years.
Arms & interventions
- RadiationMRIdian Radiation Treatment Unit
partial breast irradiation using 3 x 8.2 Gy to the lumpectomy cavity with a 3mm planning tumor volume (PTV) margin
Outcome measures
Primary
Physician Reported Cosmesis: 1-year
The Harvard Cosmesis Scale will be used to report cosmesis at 1 year post treatment. The physician will report how the breast looks relative to original appearance or untreated breast (excellent, good, fair, poor). The physician answers 9 questions on a scale of 0-2 where 0 is none, 1 is present but does not affect cosmesis, 2 is present and affects cosmesis. Scoring is objective with lower scores indicating improved conditions.
Time frame: up to 1-year
Secondary
Participant Quality of Life: BCTOS Survey
Time frame: up to 5 years
Participant Quality of Life: Convenience of Care Scale
Time frame: up to 5 years
Participant Quality of Life: MOS SF-36 Survey
Time frame: up to 5 years
Physician Reported Cosmesis: 3-year
Time frame: up to 3 years
Physician Evaluated Fat Necrosis
Time frame: up to 5 years
Acute Radiation Toxicity
Time frame: up to 90 days from completion of radiation therapy
Late Radiation Toxicity
Time frame: up to 5 years
Ipsilateral Breast Tumor Recurrence (IBTR)
Time frame: up to 5 years
Ipsilateral Regional Nodal Recurrence
Time frame: up to 5 years
Disease Free Survival (DFS)
Time frame: up to 5 years
Overall Survival (OS)
Time frame: up to 5 years
Eligibility criteria
Study locations (1)
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705