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Using the Conture® Multi-Lumen Balloon to Deliver Accelerated Partial Breast Brachytherapy
This study is currently recruiting participants.
Verified by Virginia Commonwealth University, June 2008
Sponsored by: Virginia Commonwealth University
Information provided by: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00699101
  Purpose

This multiple site, prospective, non-randomized study has been designed to compile information on the efficacy of the Contura™ MLB in delivering APBI in appropriately selected patients through evaluation of dosimetric success as compared with a single central lumen balloon device and through treatment outcomes.


Condition Intervention Phase
Breast Cancer
Device: Contura Multi-Lumen Balloon
Phase IV

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Bio-equivalence Study
Official Title: A Multi-Site Prospective, Non Randomized Study Utilizing the Conture® Multi-Lumen Balloon (MLB) Breast Brachytherapy Applicator to Deliver Accelerated Partial Breast Irradiation: Analysis of Dosimetric Success, Local Tumor Control, Cosmetic Outcome, Acute and Chronic Toxicity, and Clinical Scenarios for Optimal Use

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Dosimetric efficacy of the Contura™ MLB with the historical efficacy rate of a single central lumen balloon device. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quantify the dosimetric improvement of multi-lumen use over single lumen use through dosimetric comparison. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 342
Study Start Date: June 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Contura Multi-Lumen Balloon
Device: Contura Multi-Lumen Balloon
Placement of the balloon in a separate procedure using ultrasound guidance after surgery for breast cancer.

Detailed Description:

Data collected during this study will include baseline patient demographics, information related to the time of implant, radiation therapy details, and removal of the device as well as recurrence data, cosmetic outcomes and toxicities. The patient's follow-up data will be collected during the patient's standard follow-up visits.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able and willing to sign informed consent
  • Age 50 or older at diagnosis
  • Life expectancy greater than 10 years (excluding diagnosis of breast cancer).
  • Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (negative surgical margins per NSABP criteria).
  • On histologic examination, the tumor must be DCIS or invasive breast carcinoma. For patients with invasive breast cancer, an axillary staging procedure must be performed. Either:

    1. sentinel node biopsy (SNB) alone if sentinel node(s) is/are negative; or
    2. axillary dissection (minimum of six axillary nodes removed); and
    3. the axillary node(s) must be pathologically negative.
  • The T stage must be Tis, T1, or T2. If T2, the tumor must be ≤ 3.0 cm in maximum diameter.
  • Estrogen receptor positive tumor

Exclusion Criteria:

  • Age < 50 at diagnosis (regardless of histology)
  • Pregnant or breast-feeding (if appropriate, patient must use birth control during the study)
  • Active collagen-vascular disease
  • Paget's disease of the breast
  • History of DCIS or invasive breast cancer
  • Prior breast or thoracic RT for any condition
  • Multicentric carcinoma (DCIS or invasive)
  • Synchronous bilateral invasive or non-invasive breast cancer
  • Surgical margins that cannot be microscopically assessed or that are positive or close
  • Positive axillary node(s)
  • T stage of T2 with the tumor > 3 cm in maximum diameter or a T stage > 3
  • Estrogen receptor negative tumor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699101

Contacts
Contact: Natasha Behrmann 949-362-4800 ext 145 nbehrmann@senorx.com

Locations
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298-0058
Contact: Douglas W. Arthur, MD     804-828-7232     DArthur@mcvh-vcu.edu    
Contact: Diane Holdford, RN     804-828-0296     djholdfo@vcu.edu    
Principal Investigator: Douglas W. Arthur, MD            
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Study Chair: Douglas W. Arthur, MD Virginia Commonwealth University
  More Information

Responsible Party: Virginia Commonwealth University ( Douglas W. Arthur, MD )
Study ID Numbers: SENORX-S07-002
Study First Received: June 12, 2008
Last Updated: June 12, 2008
ClinicalTrials.gov Identifier: NCT00699101  
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Breast Cancer
Conture®
Brachytherapy

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009