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| Sponsors and Collaborators: |
Massachusetts General Hospital Dana-Farber Cancer Institute Brigham and Women's Hospital Beth Israel Deaconess Medical Center Boston Medical Center |
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00694577 |
Purpose
The purpose of this study is to determine the feasibility of partial breast irradiation in participants with early invasive or non-invasive breast cancer.
| Condition | Intervention | Phase |
|
Ductal Breast Cancer |
Radiation: Partial Breast Irradiation |
Phase I |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer: A Phase I Feasibility/Pilot Study |
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2003 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
Group 1: Experimental
Study Participants 1-100
|
Radiation: Partial Breast Irradiation
32 Gy-8 Treatments, 4 Treatment Days
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Group 2: Experimental
Study Participants 101-200
|
Radiation: Partial Breast Irradiation
36 Gy- 9 Treatments, 4 1/2 Treatment Days
|
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Group 3: Experimental
Study Participants 201-300
|
Radiation: Partial Breast Irradiation
40 Gy-10 Treatments, 5 Treatment days
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Alphonse Taghian, MD, PhD | 617-726-6050 | |
| Contact: Jeanette Gentile | 617-643-0056 |
| United States, Massachusetts | |||||
| Massachusetts General Hospital | Recruiting | ||||
| Boston, Massachusetts, United States, 02214 | |||||
| Principal Investigator: Alphonse Taghian, MD, PhD | |||||
| Dana-Farber Cancer Institute | Recruiting | ||||
| Boston, Massachusetts, United States, 02115 | |||||
| Principal Investigator: Jay Harris, MD | |||||
| Beth Israel Deaconess Medical Center | Recruiting | ||||
| Boston, Massachusetts, United States, 02115 | |||||
| Principal Investigator: Abram Recht, MD | |||||
| Boston Medical Center | Recruiting | ||||
| Boston, Massachusetts, United States, 02118 | |||||
| Contact: Lisa kachnic, MD 617-638-7070 | |||||
| Massachusetts General Hospital |
| Dana-Farber Cancer Institute |
| Brigham and Women's Hospital |
| Beth Israel Deaconess Medical Center |
| Boston Medical Center |
| Principal Investigator: | Alphonse Taghian, MD, PhD | Massachusetts General Hospital |
More Information
| Responsible Party: | Massachusetts General Hospital ( Alphonse Taghian, MD, PhD ) |
| Study ID Numbers: | 03-179 |
| First Received: | June 6, 2008 |
| Last Updated: | June 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00694577 |
| Health Authority: | United States: Institutional Review Board |
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