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 — RADIATION20Gy to surface of tumor bed and 5Gy at depth of 1cm from surface of tumor bed
- Intraoperative radiotherapy — DEVICE20gy 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: 1Patients will receive IORT
Primary Outcome Measure
Reoperation (Re-excision or Mastectomy) Rates Following WLE or IORT [ Time Frame: 30 days ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | - |
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