Preoperative Single-Fraction Radiotherapy in Early Stage Breast Cancer

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT02482376
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Stereotactic body radiotherapy ( SBRT) — RADIATION
    Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer

Study Details

This protocol seeks to build on the favorable results of the investigators' phase I trial (Pro00015617) by extending the findings to a larger cohort of subjects.In this study, the investigators hypothesize that 21Gy (Gray) as a single fraction can be delivered preoperatively to a larger group of subjects (n100). The primary objective is to determine physician reported rates of good/excellent cosmesis at baseline and 6 months, 1, 2, and 3 years post-treatment as measured by the NRG cosmesis scale

Key Dates

Start date
Oct 21, 2015
Status verified
Mar 2026
Primary completion
Mar 10, 2025
Completion
Mar 10, 2032

Study Design

Enrollment
110 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Single arm 21Gy stereotactic radiotherapy
    Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery.

Primary Outcome Measure

Number of Participants With Physician Reported Rates of Good/Excellent Cosmesis [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Cancer CenterDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Duke Cancer Center· Durham, NC

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