Internal Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ

Breast Cancer Clinical Trial

Official title: Twin Cities Brachytherapy Study for Ductal Carcinoma in Situ A Phase II Trial

Status Terminated

Clinical Trial Summary

RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving internal radiation therapy using a special radiation therapy device may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well internal radiation therapy after lumpectomy works in treating women with ductal carcinoma in situ.

Clinical Trial Description

OBJECTIVES:

Primary

• Determine the ipsilateral breast tumor recurrence rate in women with ductal carcinoma in situ undergoing lumpectomy followed by brachytherapy using the MammoSite^® Radiation Therapy System.

Secondary

• Determine the early and late complication rates and cosmetic outcome in these patients after treatment.

OUTLINE: Patients undergo lumpectomy. Patients with negative tumor margins* (no ink on tumor) undergo placement of the MammoSite^® Radiation Therapy System at the time of lumpectomy or within 4 weeks after surgery.

NOTE: *If positive margins are present, the surgeon may elect to resect the positive margins and then insert a new MammoSite® device if all other eligibility criteria are met.

Beginning 2-5 days after placement of the MammoSite^®, patients undergo brachytherapy through the MammoSite^® twice daily for 5 days (a total of 10 fractions).

After completion of study treatment, patients are followed periodically for ≥ 5 years. ;

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating

• NCT number: NCT00290654
• Study type: Interventional
• Source: Masonic Cancer Center, University of Minnesota
• Status: Terminated
• Phase: Phase 2
• Start date: December 2002
• Completion date: March 2013