Breast Cancer Clinical Trial
Official title:
A Pilot Clinical Trial to Evaluate High Dose Rate Intracavitary Brachytherapy as the Sole Method of Radiation Therapy for Favorable Stage I and II Breast Cancer
The purpose of this study is to understand the side effects (skin reaction, infection and abscess formation) at the site of radiation treatment, which my occur during the treatment and following 2 months using a new method of radiation therapy for breast cancer.
- Radiation treatment will be delivered in an outpatient setting, twice a day in 5
consecutive treatment days. There will be a minimum 6-hour interval between the two
daily treatments. The applicator is a simple tube with an inflatable balloon at one
end, a channel in the middle of the tube for treatment, and two adapters at the other
end.
- Following surgical removal of the breast cancer, the radiation oncologist with the
assistance of the surgeon or radiologist will place the applicator in the surgical
cavity. A small radioactive source, iridium-192, will be inserted into the applicator
by a special machine and after the final treatment, the applicator will be removed.
- The following procedures will be done while the patient is on radiation therapy:
post-partial mastectomy mammogram of micro-calcifications to confirm complete removal;
CT scans for radiation treatment planning; monitoring of the skin for side effects;
photographs of the breasts prior to the surgery, prior to placement of the applicator
and at 60 days after radiation treatment to evaluate the cosmetic outcome of the
treatment.
- Participation in this study will last approximately 2 months after completion of
radiation treatment.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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