Partial Breast Irradiation With Interstitial High Dose Rate Brachytherapy

Phase 2

• Conditions: Breast Cancer
• Interventions: Radiation: interstitial high dose-rate brachytherapy, PBI

• Registration Number: NCT00499057
• Lead Sponsor: University Of Perugia

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.

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2007-07-09
• Study First Submitted QC: 2007-07-10
• Study First Posted: 2007-07-11
• Status Verified: 2010-06
• Last Update Submitted: 2014-12-19
• Last Update Posted: 2014-12-23
• Primary Completion: 2015-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm study	interstitial high dose-rate brachytherapy, PBI	single arm study

Primary Outcome Measures

Name	Time	Method
cancer related deaths	6 months
local relapses	6 months

Secondary Outcome Measures

Name	Time	Method
quality of life	6 months
cosmetic results	6 months
toxicity	6 months

Trial Locations

Locations (1)

Radiation Oncology Institute; 🇮🇹 Perugia, Italy