High Dose Rate Intracavitary Brachytherapy as the Sole Method of Radiation Therapy for Breast Carcinoma
Stopped early · Not applicable
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT00165581
- Run by
- Dana-Farber Cancer Institute
- People needed
- 15
- Starts
- 2002-12-01
- Expected to finish
- 2006-10-01
- Last updated by the study team
- 2007-12-21
Who can join
Age: 45 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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