Multi-catheter High Dose Rate (HDR) Breast Brachytherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00214149
Recruitment Status : Terminated (lost funding)
First Posted : September 21, 2005
Last Update Posted : June 18, 2013
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Radiation: brachytherapy Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A UW Phase II Trial of Multi-catheter HDR Brachytherapy Following Lumpectomy for Early Stage Breast Breast Cancer
Study Start Date : October 2004
Actual Primary Completion Date : April 2008
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
breast brachytherapy to a dose of 34 Gy
Radiation: brachytherapy
breast brachytherapy to 34 Gy

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To determine if brachytherapy will produce non-inferior toxicity to XRT at 3 years [ Time Frame: 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00214149

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

Responsible Party: University of Wisconsin, Madison Identifier: NCT00214149     History of Changes
Other Study ID Numbers: RO04102
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013

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