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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00165581
• Other study ID #: 02-259
• Status: Terminated
• Phase: N/A
• First received: September 13, 2005
• Last updated: December 20, 2007
• Start date: December 2002
• Est. completion date: October 2006

Study information

• Verified date: December 2007
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• High Dose Intracavitary Brachytherapy

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.