Twin Cities Brachytherapy Study for Ductal Carcinoma in Situ A Phase II Trial
Twin Cities Brachytherapy Study for Ductal Carcinoma in Situ A Phase II Trial
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.
OBJECTIVES:
Primary
Secondary
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.
Inclusion Criteria:
Exclusion Criteria: