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Multi-Catheter High Dose Rate (HDR) Breast Brachytherapy
This study has been suspended.
( lost funding )
First Received: September 13, 2005   Last Updated: October 24, 2008   History of Changes
Sponsor: University of Wisconsin, Madison
Information provided by: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214149
  Purpose

Breast conservation therapy (BCT) is now widely accepted as a treatment option for most women with Stage I and II invasive breast cancer and most patients with ductal carcinoma in situ (DCIS). Despite superior cosmetic outcome, BCT is more complex and requires a protracted treatment regimen comprised of 6 weeks of daily external beam radiation therapy to the whole breast. The purpose of this study is to determine if an acceptable outcome can be achieved with radiation delivered only to the region of the tumor bed. If this is true, partial breast irradiation may lend itself to much shorter treatment times (one week) and the toxicities to adjacent normal structures (heart, lung, chest wall) will be greatly reduced.


Condition Intervention Phase
Breast Cancer
Radiation: brachytherapy
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment
Official Title: A UW Phase II Trial of Multi-Catheter HDR Brachytherapy Following Lumpectomy for Early Stage Breast Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • To determine if brachytherapy will produce non-inferior local regional control at 5 years post treatment when compared to historical results of conventional XRT [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if brachytherapy will produce non-inferior toxicity to XRT at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: October 2004
Estimated Study Completion Date: October 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
breast brachytherapy to a dose of 34 Gy
Radiation: brachytherapy
breast brachytherapy to 34 Gy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Invasive breast cancer or DCIS, tumor stage of Tis, T1, T2 if lesion is < 3 cm, N0 or N1 if 1-3 + nodes with no extracapsular extension
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00214149

Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Rakesh Patel, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University Wisconsin Comprehensive Cancer Center ( Rakesh Patel, M.D. )
Study ID Numbers: RO04102, uknown
Study First Received: September 13, 2005
Last Updated: October 24, 2008
ClinicalTrials.gov Identifier: NCT00214149     History of Changes
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on February 08, 2010