Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age40+
SponsorUniversity of Wisconsin, Madison
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants should have no contraindications to undergo MRI scan as part of radiotherapy planning and treatment.
Lumpectomy cavity must be clearly visible on CT and MRI scan at radiotherapy simulation.
Pregnancy test negative in women of child bearing potential (WOCBP).
The participant must consent to be in the study and must have signed an approved consent form conforming with institutional guidelines.
Disqualifiers
Men are not eligible for this study.
BRCA1/2 mutation positivity.
Age < 40 years (American Society for Radiation Oncology (ASTRO) Unsuitable Criteria).
Positive resection margins on post operative pathology(ASTRO Unsuitable Criteria).
Trial design
Design model
Single group
Treatments tested in this trial
MRIdian Radiation Treatment Unit
Radiationpartial breast irradiation using 3 x 8.2 Gy to the lumpectomy cavity with a 3mm planning tumor volume (PTV) margin
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: 8.2 Gy Radiation TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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-yearSecondary outcomes
1
Participant Quality of Life: BCTOS Survey
Participant Quality of Life will be assessed prior to starting treatment, at end of radiotherapy (RT), 4 weeks post RT, 6 months post RT, 12 months post RT and yearly through 5 years by collecting measures from three scales.The Breast Cancer Treatment Outcomes Scale (BCTOS) is a 22-item scale scored 1-4 where 1 is none, 2 is slight, 3 is moderate, and 4 is large. Total score ranges from 22-88 where lower scores indicated better outcomes.
Time frame
up to 5 years2
Participant Quality of Life: Convenience of Care Scale
Participant Quality of Life will be assessed prior to starting treatment, at end of radiotherapy (RT), 4 weeks post RT, 6 months post RT, 12 months post RT and yearly through 5 years by collecting measures from three scales. The Convenience of Care scale is an 8-item scale scored 0 (not at all) to 10 (a lot). The total score ranges from 0-80 where lower scores indicate less disruptive interventions.
Time frame
up to 5 years3
Participant Quality of Life: MOS SF-36 Survey
Participant Quality of Life will be assessed prior to starting treatment, at end of radiotherapy (RT), 4 weeks post RT, 6 months post RT, 12 months post RT and yearly through 5 years by collecting measures from three scales.The Medical Outcomes Study Short Form - 36 (MOS SF-36) Vitality scale measures how a participant has felt in the last 4 weeks. 4-items are scored from 1-5 where 1 is all of the time and 5 is none of the time. 4-items are scored from 0 (no pain) to 10 (pain as bad as you can imagine). Total score ranges from 4-60 where lower scores indicate increased vitality.
Time frame
up to 5 years4
Physician Reported Cosmesis: 3-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 3 yearsSponsors and contacts
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Source ClinicalTrials.gov