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Sponsored by: |
Xoft, Inc. |
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Information provided by: | Xoft, Inc. |
ClinicalTrials.gov Identifier: | NCT00742222 |
PRINCIPAL INVESTIGATORS
REGISTRY DESIGN
SAMPLE SIZE AND SITES:
ENDPOINTS:
PRIMARY ENDPOINTS
SECONDARY ENDPOINTS
This includes:
Axillary nodal recurrence
Disease Free Survival
The device to be used is the electronic brachytherapy system for the treatment of early stage breast cancer with intracavitary accelerated partial breast irradiation. The device manufacturer is Xoft, Incorporated. All Xoft technology cleared by the FDA for the treatment of early stage breast cancer can be used in this post market data collection registry.
OVERSIGHT COMMITTEE
Representatives from American Brachytherapy Society (ABS), American Society of Breast Surgeons (ASBS), and American College of Radiation Oncology (ACRO)will oversee study management.
Condition | Intervention |
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Breast Cancer Carcinoma Lumpectomy Ductal Carcinoma In Situ |
Radiation: Electronic Brachytherapy |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Electronic Xoft Intersociety Brachytherapy Trial |
Estimated Enrollment: | 400 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | March 2016 |
Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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Observational
Patients who have early stage breast cancer, and are candidate for intracavitary accelerated partial breast irradiation may be considered for this study.
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Radiation: Electronic Brachytherapy
34 Gy administered over 10 fractions, twice a day times five days. The radiation therapy treatment will be complete upon the 5th day.
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients who have had a mammogram and positive biopsy that necessitates lumpectomy for early stage breast cancer.
Patients who have had a lumpectomy due to invasive carcinoma or DCIS and will undergo radiation therapy are candidates for this study.
Inclusion Criteria:
Exclusion Criteria:
Contact: Kelly W Elliott, RN, MS | 719-640-4197 | Kelliott@xoftinc.com |
Contact: Patricia R McCarthy, RN, BA | 314-409-2899 | pmccarthy@xoftinc.com |
United States, New Jersey | |
AtlantiCare Cancer Care Institute | Recruiting |
Galloway, New Jersey, United States, 08205 | |
Contact: Louise Baca, MS 609-652-8819 Louise.Baca@atlanticare.org | |
Contact: Betty Lorenzetti (609) 677-0088 jltbj@aol.com | |
Principal Investigator: John Lorenzetti, MD | |
United States, Texas | |
Dallas Surgical Group / Northpoint Cancer Center | Recruiting |
Dallas, Texas, United States, 75230 | |
Contact: Tiffany Huber 972-566-4143 thuber@dallassurgical.com | |
Principal Investigator: Peter Beitsch, MD | |
Sub-Investigator: Timothy Nichols, MD |
Principal Investigator: | Peter Beitsch, MD | Dallas Surgical Group |
Principal Investigator: | Rakesh Patel, MD | University of Wisconsin Radiation Oncology Department |
Responsible Party: | Xoft, Inc. ( Kelly W. Elliott RN, MS Vice President Clinical Affairs ) |
Study ID Numbers: | TPR-0186 |
Study First Received: | August 25, 2008 |
Last Updated: | August 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00742222 |
Health Authority: | United States: Institutional Review Board |
Electronic brachytherapy registry Multi-society registry Breast cancer registry |
Carcinoma, Ductal Skin Diseases Carcinoma in Situ Breast Neoplasms Carcinoma, Ductal, Breast |
Carcinoma, Intraductal, Noninfiltrating Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary |