Partial Breast Irradiation With Interstitial High Dose Rate Brachytherapy

Breast Cancer Clinical Trial

Official title:

Interstitial High Dose-Rate Brachytherapy for Partial Breast Irradiation in Early Breast Cancer: Results of Phase II Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00499057
• Other study ID #: BRT-HDR
• Status: Recruiting
• Phase: Phase 2
• First received: July 9, 2007
• Last updated: December 19, 2014
• Start date: August 2003
• Est. completion date: August 2016

Study information

• Verified date: June 2010
• Source: University Of Perugia
• Contact: Cynthia Aristei, Prof. M.D.
• Phone: 00390755784306
• Email: cynthia.aristei[@]unipg.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 85 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• interstitial 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.

Locations

Country	Name	City	State
Italy	Radiation Oncology Institute	Perugia

Sponsors (1)

Lead Sponsor	Collaborator
University Of Perugia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cancer related deaths		6 months	Yes
Primary	local relapses		6 months	Yes
Secondary	quality of life		6 months	No
Secondary	cosmetic results		6 months	No
Secondary	toxicity		6 months	No