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Partial Breast Irradiation With Interstitial High Dose Rate Brachytherapy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by University Of Perugia.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Cynthia Aristei, University Of Perugia Identifier:
First received: July 9, 2007
Last updated: December 19, 2014
Last verified: June 2010
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).

Condition Intervention Phase
Breast Cancer
Radiation: interstitial high dose-rate brachytherapy, PBI
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interstitial High Dose-Rate Brachytherapy for Partial Breast Irradiation in Early Breast Cancer: Results of Phase II Prospective Study

Resource links provided by NLM:

Further study details as provided by University Of Perugia:

Primary Outcome Measures:
  • cancer related deaths [ Time Frame: 6 months ]
  • local relapses [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: 6 months ]
  • cosmetic results [ Time Frame: 6 months ]
  • toxicity [ Time Frame: 6 months ]

Estimated Enrollment: 150
Study Start Date: August 2003
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
single arm study
single arm study
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.

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.

Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00499057

Contact: Cynthia Aristei, Prof. M.D. 00390755784306

Radiation Oncology Institute Recruiting
Perugia, Italy, 06122
Contact: Cynthia Aristei, Prof. M.D.    00390755784306   
Principal Investigator: Cynthia Aristei, Prof. M.D.         
Sponsors and Collaborators
University Of Perugia
Study Director: Cynthia Aristei, Prof. M.D. University of Perugia, Italy
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cynthia Aristei, Full Professor of Rdaiotherapy, University Of Perugia Identifier: NCT00499057     History of Changes
Other Study ID Numbers: BRT-HDR
Study First Received: July 9, 2007
Last Updated: December 19, 2014

Keywords provided by University Of Perugia:
early stage breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on May 25, 2017