Clinical trial · Interventional
High Dose Rate Intracavitary Brachytherapy as the Sole Method of Radiation Therapy for Breast Carcinoma
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
NCT00165581CI-TRIAL-00001051terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to continuing review
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High Dose Intracavitary Brachytherapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.