NCT00290654

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Tamoxifen	Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient
PROCEDURE	Lumpectomy	A standard lumpectomy will be performed with an attempt to remove at least 1 cm of gross margin around the DCIS.
RADIATION	brachytherapy	Treatment will be given in 10 fractions of 3.4 Gy per fraction twice a day, with a minimum of 6 hours between fractions. In general, brachytherapy will start between 2 - 5 days of implant. All treatments will be done using a commercially available HDR and 192Ir radioactive sources.

Timeline

• Start date: 2002-12-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2006-02-13
• Last updated: 2017-12-28
• Results posted: 2015-05-15

Locations

1 site across 1 country: United States