Tangential Radiation Therapy Without Axillary Dissection in Breast Cancer
This trial is active, not recruiting.
|Condition||early-stage breast cancer|
|Sponsor||Dana-Farber Cancer Institute|
|Collaborator||Brigham and Women's Hospital|
|Start date||September 1998|
|End date||January 2004|
|Trial size||100 participants|
|Trial identifier||NCT00165243, 98-101|
The purpose of this study is to evaluate whether treatment to the axilla (area under the arm) can be safely minimized by omitting axillary surgery and full axillary radiation therapy and replacing it with radiation therapy to the breast and lower axilla.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
To determine if patients with early-stage breast tumors can be effectively treated by tangential breast radiation.
time frame: 5 years
To determine the safety of this treatment.
time frame: 5 years
Male or female participants at least 55 years old.
Inclusion Criteria: - Patients must have clinical stage I or II breast cancer, clinically uninvolved axillary nodes. - Patients must be 55 years or older. - Patients must undergo total excision of the primary invasive tumor - Final pathologic margin status must be negative - Only estrogen receptor (ER) or progesterone receptor (PR) positive tumors will be permitted Exclusion Criteria: - Prior history of malignancy, except for non-melanoma skin cancers and carcinoma in situ fo the cervix
|Official title||Tangential Radiation Therapy Without Axillary Dissection in Early-Stage Breast Cancer|
|Principal investigator||Julia S. Wong, MD|
|Description||- Patients will have undergone conservative breast surgery without axillary dissection prior to enrollment in this study. - Patients will receive radiation therapy to the breast, including the lowest axillary lymph nodes, over a period of 6 1/2 weeks. - No radiation will be specifically directed toward the upper axilla or supraclavicular lymph nodes. - Patients will also receive 5 years of tamoxifen or another type of hormone therapy determined by the medical oncologist. - Follow-up visits will occur every 6 months and mammograms every 12 months.|
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