Multi-catheter High Dose Rate (HDR) Breast Brachytherapy

Breast Cancer Clinical Trial

Official title:

A UW Phase II Trial of Multi-catheter HDR Brachytherapy Following Lumpectomy for Early Stage Breast Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00214149
• Other study ID #: RO04102
• Secondary ID: 2004-0268
• Status: Terminated
• Phase: Phase 2
• Start date: October 2004
• Est. completion date: October 2010

Study information

• Verified date: October 2018
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 127
• Est. completion date: October 2010
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• brachytherapy
breast brachytherapy to 34 Gy

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (1)

McHaffie DR, Patel RR, Adkison JB, Das RK, Geye HM, Cannon GM. Outcomes after accelerated partial breast irradiation in patients with ASTRO consensus statement cautionary features. Int J Radiat Oncol Biol Phys. 2011 Sep 1;81(1):46-51. doi: 10.1016/j.ijrobp.2010.05.011. Epub 2010 Aug 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Determine if Brachytherapy Will Produce Non-inferior Local Regional Control at 5 Years Post Treatment When Compared to Historical Results of Conventional XRT		5 years
Secondary	To Determine if Brachytherapy Will Produce Non-inferior Toxicity to XRT at 3 Years		3 years