Targeted Intra-Operative Radiotherapy for the Management of Ductal Carcinoma In-Situ of the Breast

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT00556907
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Intraoperative radiotherapy — RADIATION
    20Gy to surface of tumor bed and 5Gy at depth of 1cm from surface of tumor bed
  • Intraoperative radiotherapy — DEVICE
    20gy to tumor bed, 5gy at depth of 1cm from surface of tumor bed

Study Details

We hypothesize that the combination of mammography and CE-MRI will improve the surgeon and radiologist's ability to define extent of disease prior to surgical resection, improve the odds of obtaining clear surgical margins, and increase the efficacy of IORT delivered immediately after initial surgical resection. In this investigation, we will determine whether or not patients deemed eligible for 'immediate" IORT based on mammography and CE-MRI can be successfully treated without the need for re-excision or additional radiotherapy due to inadequate surgical margins.

Key Dates

Start date
Oct 31, 2007
Status verified
Oct 2025
Primary completion
Mar 31, 2015
Completion
Nov 30, 2016

Study Design

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

Arms

  • Other: 1
    Patients will receive IORT

Primary Outcome Measure

Reoperation (Re-excision or Mastectomy) Rates Following WLE or IORT [ Time Frame: 30 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
USC/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-

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