Status:
UNKNOWN
Dose Optimization for Pulsed-dose-rate (PDR)/High-dose-rate (HDR) Brachytherapy Alone for Early Breast Cancer
Lead Sponsor:
University Hospital Erlangen
Conditions:
Breast Cancer
Eligibility:
FEMALE
50+ years
Phase:
PHASE2
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...
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Stage 0, I or II breast cancer.
- Invasive ductal, papillary, mucinous, tubular, medullary or lobular carcinoma.
- Ductal carcinoma in situ (DCIS) alone.
- No lymph invasion (L0) and no hemangiosis (V0).
- Lesions of \< 3 cm diameter, histopathologically assured.
- pN0 (a minimum of 6 nodes in specimen, or a negative sentinel node is acceptable).
- M0.
- Clear resection margins at least 2 mm in any direction; by lobular histology or DCIS histology only the resection margins must be clear at least 5 mm.
- For DCIS only: lesions must be classified as low or intermediate risk group
- Unifocal and unicentric DCIS or breast cancer.
- Age \> 50 years.
- Time interval from final definitive breast surgical procedure to the start of external beam therapy or to brachytherapy is less than 12 weeks (84 days). If patients receive chemotherapy the radiotherapy can be started before systemic treatment (within 12 weeks). The radiation therapy can be also given in the interval between the chemotherapy courses. It is also possible to start radiation therapy after chemotherapy is completed according local protocols as soon as possible within 4 weeks after chemotherapy.
- Signed study-specific consent form
- 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.
- Patient with breast deemed technically unsatisfactory for brachytherapy.
Exclusion
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2015
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01175694
Start Date
January 1 2010
End Date
January 1 2015
Last Update
August 20 2010
Active Locations (1)
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1
Dept. of Radiation Oncology, University Hospital Erlangen
Erlangen, Germany, 91054