Partial Breast Irradiation With Interstitial High Dose Rate Brachytherapy
Interstitial High Dose-Rate Brachytherapy for Partial Breast Irradiation in Early Breast Cancer: Results of Phase II Prospective Study
1 other identifier
interventional
150
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Aug 2003
Longer than P75 for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 9, 2007
CompletedFirst Posted
Study publicly available on registry
July 11, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedDecember 23, 2014
June 1, 2010
12 years
July 9, 2007
December 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
cancer related deaths
6 months
local relapses
6 months
Secondary Outcomes (3)
quality of life
6 months
cosmetic results
6 months
toxicity
6 months
Study Arms (1)
single arm study
OTHERsingle arm study
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Radiation Oncology Institute
Perugia, Perugia, 06122, Italy
Related Publications (1)
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.
PMID: 24044802DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Cynthia Aristei, Prof. M.D.
University Of Perugia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor of Rdaiotherapy
Study Record Dates
First Submitted
July 9, 2007
First Posted
July 11, 2007
Study Start
August 1, 2003
Primary Completion
August 1, 2015
Study Completion
August 1, 2016
Last Updated
December 23, 2014
Record last verified: 2010-06