High Dose Rate Intracavitary Brachytherapy as the Sole Method of Radiation Therapy for Breast Carcinoma

Dana-Farber Cancer Institute

Status

Terminated

Conditions

Breast Cancer

Treatments

Device: High Dose Intracavitary Brachytherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00165581

02-259

Details and patient eligibility

About

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.

Full description

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.

Sex

Female

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

AJCC stage I or II histologically confirmed invasive ductal carcinoma of the breast with a lesion < or = to 3cm, treated with partial mastectomy
45 years of age or older
Negative inked pathologic specimen
> or = to 3mm margins of partial mastectomy or re-excision specimen to be confirmed prior to introducing radiation source
Negative post-partial mastectomy or post re-excision mammography if cancer presented with malignancy-associated microcalcifications; no remaining suspicious microcalcifications in the breast before brachytherapy
Invasive ductal, medullary, papillary, colloid, or tubular histologies
Time interval from final definitive breast surgical procedure to brachytherapy treatment is less than 8 weeks

Exclusion criteria

Distant metastases
Invasive lobular carcinoma or pure ductal carcinoma in situ or nonepithelial breast malignancies such as sarcoma or lymphoma
Proven multifocal, multicentric carcinoma with other clinically or radiologically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy
Pregnant or lactating
Confirmed positive axillary nodes in the ipsilateral axilla. Palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor
Prior non-hormonal therapy for the present breast cancer, including radiation therapy and chemotherapy
Collagen vascular diseases, specifically systemic lupus erythematosis, scleroderma, keloid, ataxia, telangiectasia, or dermatomyositis
Co-existing medical condition in whom life expectancy is < 2 years
Psychiatric or addictive disorders
Paget's disease of the nipple
Skin involvement regardless of size
Breast unsatisfactory for brachytherapy
Surgical margins which cannot be microscopically assessed or are positive at pathological evaluation
Extensive intraductal carcinoma
Any previously treated contralateral breast carcinoma or synchronous bilateral breast carcinoma
Other malignancy, except non-melanoma skin cancer, < 5 years prior to participation in this study
Diffuse suspicious microcalcifications