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Sponsored by: |
Washington University School of Medicine |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00325598 |
This study investigates the feasibility and safety of delivering radiation therapy only to part of the breast, (the tumor bed and selected areas) rather than the whole breast, for patients with early stage breast cancer.
Condition | Intervention | Phase |
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Breast Neoplasms |
Procedure: Partial Breast Irradiation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Partial Breast Irradiation (PBI) for Selected Patients With Early Breast Cancer: A Phase I Feasibility Study |
Estimated Enrollment: | 50 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | February 2030 |
Estimated Primary Completion Date: | February 2030 (Final data collection date for primary outcome measure) |
Group 1 (enrollment completed):
Partial Breast Irradiation: 36 Gy in 9 fractions, given twice daily over 4.5 treatment days and a one week period.
Group 2:
Partial Breast Irradiation: 40 Gy in 10 fractions, given twice daily over 5 treatment days and a one week period.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Radiation therapy should begin within:
Exclusion Criteria:
Histological evidence of:
Patients with a "currently active" second malignancy other than non-melanoma skin cancers.
Patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 5% risk of relapse within three years.
Contact: Linda M. Brockman | 314-454-7986 | brockmal@ccadmin.wustl.edu |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Principal Investigator: Simon N. Powell, M.D., Ph.D. |
Principal Investigator: | Imran Zoberi, M.D. | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine ( Simon Powell, M.D. ) |
Study ID Numbers: | 05-1053 |
Study First Received: | May 12, 2006 |
Last Updated: | February 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00325598 History of Changes |
Health Authority: | United States: Institutional Review Board |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |