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
- 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the technical feasibility and acute 60-day toxicity of intracavitary HDR brachytherapy when used as the sole method of radiation therapy for patients with Stage I and II breast cancer.
Phillip M. Devlin, MD
Principal Investigator
Brigham and Women's Hospital
United States: Institutional Review Board
02-259
NCT00165581
December 2002
October 2006
Name | Location |
---|---|
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Brigham and Women's Hospital | Boston, Massachusetts 02115 |