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Partial Breast Irradiation With Interstitial High Dose Rate Brachytherapy
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
early stage breast cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: interstitial high dose-rate brachytherapy, PBI
Type: Radiation
Overall Status
Recruiting
Summary
Partial breast irradiation (PBI) is becoming more widespread in the treatment of early breast cancer in patients at low risk of relapse as pathological and clinical findings have demonstrated that most breast cancer recurrences after BCS occur close to the tumour bed. In our phase II prospective study PBI is administered with high-dose-rate brachytherapy in patients with low-risk early-stage breast cancer. Patients receive 4 Gy twice a day for 4 days (total dose 32 Gy).
Detailed Description
Patients included in our phase II trial of PBI with interstitial HDR brachytherapy are at low-risk of relapse. Implants are positioned during surgery or postoperatively, within 12 weeks. Treatment schedule is 4 Gy twice a day, with a time relapse of at least 6 hours between each fraction, for four days, for a total dose 32 Gy. Before post-operative implantation, all patients undergo a breast computed tomography (CT) scan to visualize and expand the excision cavity and obtain the planning target volume (PTV), i.e. the lumpectomy cavity plus a margin of 1-2 cm around it. Through virtual simulation with a 3D treatment planning system (TPS), we define the implant catheter position. After implantation, in all patients a breast CT scan checked implant geometry. On CT images transferred to a TPS the surgical cavity is outlined and expanded, the PTV defined, and inactive and active source lengths measured.CT-based 3D software is used to identify and reconstruct the catheters, outline and expand the surgical cavity and obtain the PTV. Dwell positions are activated for each catheter, and inactive and active lengths defined.Prescribed dose was 85% of the basal dose. Dwell weights are optimised in the basal points applying the volume and distance method and best values were chosen independently of strategy. A dose-volume histogram that records the volume covered by 100% and 150% of the prescribed dose (V100 and V150) was obtained for each patient. DHI, defined as V150 - V100/ V100 (7), is recognized as the most suitable quality index.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 85 Years
Minimum Age: 40 Years
Gender: Female
Criteria: Inclusion Criteria:
- Age > or = 40 years
- ECOG performance status 0-2
- T dimensions ≤ 2.5 cm
- Negative surgical margins
- Negative axillary lymph nodes
- Suitable breast anatomy for implantation
Exclusion Criteria:
- Age < 40 years
- ECOG performance status > 2
- T dimensions > 2.5
- Positive surgical margins
- Positive axillary lymph node
- Infiltrating lobular histology
- Significant areas of lobular carcinoma in situ
- Paget's disease of the nipple
- Extensive intraductal component (EIC)
- Lymphovascular invasion
- Multifocality (n) skin infiltration
- Age > or = 40 years
- ECOG performance status 0-2
- T dimensions ≤ 2.5 cm
- Negative surgical margins
- Negative axillary lymph nodes
- Suitable breast anatomy for implantation
Exclusion Criteria:
- Age < 40 years
- ECOG performance status > 2
- T dimensions > 2.5
- Positive surgical margins
- Positive axillary lymph node
- Infiltrating lobular histology
- Significant areas of lobular carcinoma in situ
- Paget's disease of the nipple
- Extensive intraductal component (EIC)
- Lymphovascular invasion
- Multifocality (n) skin infiltration
Location
Radiation Oncology Institute
Perugia, Italy
Status: Recruiting
Contact: Cynthia Aristei, Prof. M.D. - 00390755784306 - cynthia.aristei@unipg.it
Start Date
August 2003
Completion Date
August 2016
Sponsors
University Of Perugia
Source
University Of Perugia
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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