Partial Breast Irradiation With Interstitial High Dose Rate Brachytherapy
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
interstitial high dose-rate brachytherapy, PBI
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring early stage breast cancer
Eligibility 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
Sites / Locations
- Radiation Oncology InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
single arm study
Arm Description
single arm study
Outcomes
Primary Outcome Measures
cancer related deaths
local relapses
Secondary Outcome Measures
quality of life
cosmetic results
toxicity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00499057
Brief Title
Partial Breast Irradiation With Interstitial High Dose Rate Brachytherapy
Official Title
Interstitial High Dose-Rate Brachytherapy for Partial Breast Irradiation in Early Breast Cancer: Results of Phase II Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2003 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Of Perugia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
early stage breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single arm study
Arm Type
Other
Arm Description
single arm study
Intervention Type
Radiation
Intervention Name(s)
interstitial high dose-rate brachytherapy, PBI
Intervention Description
Single arm study 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.
Primary Outcome Measure Information:
Title
cancer related deaths
Time Frame
6 months
Title
local relapses
Time Frame
6 months
Secondary Outcome Measure Information:
Title
quality of life
Time Frame
6 months
Title
cosmetic results
Time Frame
6 months
Title
toxicity
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia Aristei, Prof. M.D.
Phone
00390755784306
Email
cynthia.aristei@unipg.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Aristei, Prof. M.D.
Organizational Affiliation
University Of Perugia
Official's Role
Study Director
Facility Information:
Facility Name
Radiation Oncology Institute
City
Perugia
ZIP/Postal Code
06122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Aristei, Prof. M.D.
Phone
00390755784306
Email
cynthia.aristei@unipg.it
First Name & Middle Initial & Last Name & Degree
Cynthia Aristei, Prof. M.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
24044802
Citation
Aristei C, Palumbo I, Capezzali G, Farneti A, Bini V, Falcinelli L, Margaritelli M, Lancellotta V, Zucchetti C, Perrucci E. Outcome of a phase II prospective study on partial breast irradiation with interstitial multi-catheter high-dose-rate brachytherapy. Radiother Oncol. 2013 Aug;108(2):236-41. doi: 10.1016/j.radonc.2013.08.005. Epub 2013 Sep 14.
Results Reference
derived
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Partial Breast Irradiation With Interstitial High Dose Rate Brachytherapy
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