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| Sponsor: | USC/Norris Comprehensive Cancer Center |
|---|---|
| Information provided by: | USC/Norris Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00556907 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Radiation: Intraoperative radiotherapy Device: Intraoperative radiotherapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Targeted Intra-Operative Radiotherapy for the Management of Ductal Carcinoma In-Situ of the Breast (TARGIT-DCIS Trial): Use of Mammography and Breast MRI to Identify Candidates for IORT. |
| Estimated Enrollment: | 116 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Patients will receive IORT
|
Radiation: Intraoperative radiotherapy
20Gy to surface of tumor bed and 5Gy at depth of 1cm from surface of tumor bed
Device: Intraoperative radiotherapy
20gy to tumor bed, 5gy at depth of 1cm from surface of tumor bed
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion Criteria for Initial Registration (all patients cohorts):
All cohorts
Cohort 1 (Immediate IORT group)
Exclusion Criteria:
Contacts and Locations| Contact: Dennis Holmes, MD | 323/865-3933 | dholmes@usc.edu |
| United States, California | |
| USC/Norris Comprehensive Cancer Center | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Contact: Jackie Major, RN 323-226-6354 Major_J@ccnt.usc.edu | |
| Principal Investigator: | Dennis Holmes, MD | USC/Norris Comprehensive Cancer Center |
More Information
| Responsible Party: | University of Southern California ( Dr. Dennis Holmes ) |
| Study ID Numbers: | 1B-06-9 |
| Study First Received: | November 8, 2007 |
| Last Updated: | July 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00556907 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
DCIS To evaluate Preoperative mammagraphy and MRI to select candiates with DCIS for IORT |
|
Neoplasms by Histologic Type Skin Diseases Breast Neoplasms Carcinoma Carcinoma, Ductal Neoplasms Neoplasms by Site |
Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Neoplasms, Ductal, Lobular, and Medullary Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial |