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Partial Breast Irradiation With Interstitial High Dose Rate Brachytherapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University Of Perugia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Of Perugia
ClinicalTrials.gov Identifier:
NCT00499057
First received: July 9, 2007
Last updated: August 9, 2011
Last verified: June 2010
History of Changes
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by University Of Perugia:

Primary Outcome Measures:
  • cancer related deaths [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • local relapses [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • cosmetic results [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • toxicity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: August 2003
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: interstitial high dose-rate brachytherapy, PBI
    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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00499057

Contacts
Contact: Cynthia Aristei, Prof. M.D. 00390755784306 cynthia.aristei@unipg.it

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

No publications provided

Responsible Party: University of Perugia
ClinicalTrials.gov Identifier: NCT00499057     History of Changes
Other Study ID Numbers: BRT-HDR
Study First Received: July 9, 2007
Last Updated: August 9, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by University Of Perugia:
early stage breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013