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| Sponsor: | University of Wisconsin, Madison |
|---|---|
| Information provided by: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT00214149 |
Purpose
Breast conservation therapy (BCT) is now widely accepted as a treatment option for most women with Stage I and II invasive breast cancer and most patients with ductal carcinoma in situ (DCIS). Despite superior cosmetic outcome, BCT is more complex and requires a protracted treatment regimen comprised of 6 weeks of daily external beam radiation therapy to the whole breast. The purpose of this study is to determine if an acceptable outcome can be achieved with radiation delivered only to the region of the tumor bed. If this is true, partial breast irradiation may lend itself to much shorter treatment times (one week) and the toxicities to adjacent normal structures (heart, lung, chest wall) will be greatly reduced.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Radiation: brachytherapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment |
| Official Title: | A UW Phase II Trial of Multi-Catheter HDR Brachytherapy Following Lumpectomy for Early Stage Breast Breast Cancer |
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2004 |
| Estimated Study Completion Date: | October 2009 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
breast brachytherapy to a dose of 34 Gy
|
Radiation: brachytherapy
breast brachytherapy to 34 Gy
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| United States, Wisconsin | |
| University of Wisconsin Hospital and Clinics | |
| Madison, Wisconsin, United States, 53792 | |
| Principal Investigator: | Rakesh Patel, MD | University of Wisconsin, Madison |
More Information
| Responsible Party: | University Wisconsin Comprehensive Cancer Center ( Rakesh Patel, M.D. ) |
| Study ID Numbers: | RO04102, uknown |
| Study First Received: | September 13, 2005 |
| Last Updated: | October 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00214149 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |