Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT03936478
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MRIdian Radiation Treatment Unit — RADIATION
    partial breast irradiation using 3 x 8.2 Gy to the lumpectomy cavity with a 3mm planning tumor volume (PTV) margin

Study Details

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.

Key Dates

Start date
May 16, 2022
Status verified
Jun 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2031

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 8.2 Gy Radiation Therapy
    Accelerated partial breast irradiation using 3 x 8.2 Gy to the lumpectomy cavity with a 3mm PTV margin. Treatment duration will be 5-6 days and treatments will be on alternative weekdays, with a minimum interval of 40 hours between subsequent fractions.

Primary Outcome Measure

Physician Reported Cosmesis: 1-year [ Time Frame: up to 1-year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53705
Cancer Connect
[email protected]
800-622-8922
Bethany Anderson, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Madison, WI

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Wisconsin Carbone Cancer Center· Madison, WI

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