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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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00499057
Enrollment
150
Registered
2007-07-11
Start date
2003-08-31
Completion date
2016-08-31
Last updated
2014-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

early stage breast cancer

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.

Interventions

RADIATIONinterstitial high dose-rate brachytherapy, PBI

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.

Sponsors

University Of Perugia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
cancer related deaths6 months
local relapses6 months

Secondary

MeasureTime frame
quality of life6 months
cosmetic results6 months
toxicity6 months

Countries

Italy

Contacts

Primary ContactCynthia Aristei, Prof. M.D.
cynthia.aristei@unipg.it00390755784306

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026