Status:
TERMINATED
High Dose Rate Intracavitary Brachytherapy as the Sole Method of Radiation Therapy for Breast Carcinoma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
45+ years
Phase:
NA
Brief 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 mon...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00165581
Start Date
December 1 2002
End Date
October 1 2006
Last Update
December 21 2007
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115