Phase II Study - Dose Optimization PDR/HDR Brachytherapy Alone for Early Breast Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- University Hospital Erlangen
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- local control rates
- Last Updated
- 15 years ago
Overview
Brief Summary
Accelerated partial breast irradiation (APBI) leads to a equivalent local control rate with lower toxicity as external beam irradiation (EBI) after breast conserving surgery (BCS) in a highly selected subgroup of patients with low risk invasive carcinoma and low risk duct carcinoma in-situ (DCIS). The goal of this trial is to assess the role of a modified dose of pulsed-dose-rate (PDR) and high-dose-rate (HDR) brachytherapy alone as Accelerated Partial Breast Irradiation (APBI) in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences), in particular regarding the local recurrences, the toxicity and for the cosmetic result. It is a phase II study. According to study protocol altogether 200 female patients will be treated.
Detailed Description
Focus of this trial is to assess the role a modified dose of PDR- and HDR-brachytherapy as Accelerated Partial Breast Irradiation (APBI) alone in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure(all ipsilateral local recurrences, in particular regarding the local recurrences, the toxicity and for the cosmetic result.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Stage III or IV breast cancer.
- •Surgical margins that cannot be microscopically assessed.
- •Extensive intraductal component (EIC).
- •Paget's disease or pathological skin involvement.
- •Synchronous or previous breast cancer.
- •Prior malignancy (\< 5 years prior to enrollment in study) except non-melanoma skin cancer or cervical carcinoma International Federation of Gynecology and Obstetrics (FIGO) 0 and I if patient is continuously disease-free.
- •Pregnant or lactating women.
- •Collagen vascular disease.
- •The presence of congenital diseases with increased radiation sensitivity, for example Ataxia telangiectatic or similar.
- •Psychiatric disorders.
Outcomes
Primary Outcomes
local control rates
Time Frame: five years
Secondary Outcomes
- late side effects(5 years)