Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT)

Part of paid clinical trials in Stuart, Florida.

Sponsor
RPCR, Inc.
Study ID
NCT04985032
Status
Recruiting
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Conditions

  • Ductal Carcinoma in Situ
  • Invasive Ductal Carcinoma of Female Breast

Eligibility Criteria

Sex
FEMALE
Age
50 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • stereotactic body radiation therapy — RADIATION
    Treatment technique used to deliver a highly focused and accurate radiation dose to a defined target volume outside the brain; the entire course of therapy delivered in five fractions or less

Study Details

This is a multi-institutional, prospective, observational registry investigating the safety and efficacy of Accelerated Partial Breast Irradiation (APBI) using a Stereotactic Body Radiation Therapy (SBRT) delivery technique that incorporates real-time image guidance, noncoplanar fields, and respiratory tracking. The study will accrue 200 patients who will be treated to a dose of 30 Gy over the course of 5 fractions. These subjects will then have a follow up time of 5 years

Key Dates

Start date
Aug 15, 2022
Status verified
Aug 2022
Primary completion
Aug 15, 2024
Completion
Jun 30, 2027

Study Design

Enrollment
200 participants (estimated)

Primary Outcome Measure

Breast Cosmesis as measured by NRG-Radiation Therapy Oncology Group (RTOG) global cosmetic score (GCS) and the Harvard Cosmesis Scale (HCS) [ Time Frame: 2-3 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
CyberKnife Center of South Florida in StuartStuartFlorida33996
Mark Perman, MD
772-403-2390
Mark Perman, MD (PRINCIPAL_INVESTIGATOR)
CyberKnife Centers of Tampa BayTampaFlorida33615
Debra Freeman, MD
[email protected]
813-884-7400
Debra Freeman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Stuart, FL

By research site
CyberKnife Center of South Florida in Stuart· Stuart, FLCyberKnife Centers of Tampa Bay· Tampa, FL

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