To hear about similar clinical trials, please enter your email below
Trial Title:
Partial Breast Irradiation With Interstitial High Dose Rate Brachytherapy
NCT ID:
NCT00499057
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
early stage breast cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
interstitial high dose-rate brachytherapy, PBI
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.
Arm group label:
single arm study
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:
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
Gender:
Female
Minimum age:
40 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Radiation Oncology Institute
Address:
City:
Perugia
Zip:
06122
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Cynthia Aristei, Prof. M.D.
Phone:
00390755784306
Email:
cynthia.aristei@unipg.it
Investigator:
Last name:
Cynthia Aristei, Prof. M.D.
Email:
Principal Investigator
Start date:
August 2003
Completion date:
August 2016
Lead sponsor:
Agency:
University Of Perugia
Agency class:
Other
Source:
University Of Perugia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00499057
