Internal Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Twin Cities Brachytherapy Study for Ductal Carcinoma in Situ A Phase II Trial|
- Ipsilateral breast tumor recurrence rate [ Time Frame: Month 6 and Yearly thereafter ] [ Designated as safety issue: No ]
- Complication rates [ Time Frame: Week 3, Month 6, Yearly ] [ Designated as safety issue: Yes ]
- Cosmetic outcome [ Time Frame: Month 6, Yearly ] [ Designated as safety issue: No ]
|Study Start Date:||December 2002|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: Lumpectomy with Brachytherapy
Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient.
Tamoxifen may be used postoperatively at the discretion of the treating physicians and patientProcedure: 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290654
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Todd M. Tuttle, MD||Masonic Cancer Center, University of Minnesota|