Status:

TERMINATED

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

Lead Sponsor:

Masonic Cancer Center, University of Minnesota

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief 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 an...

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 T...

Eligibility Criteria

Inclusion

  • Ductal carcinoma in situ (DCIS) confirmed by excisional or needle biopsy
  • Size: \< 3 cm on mammogram
  • Unicentric disease
  • Ability to place MammoSite device at time of lumpectomy or within 4 weeks of lumpectomy
  • Patient Age: ≥ 18 years, no upper limit
  • Life expectancy \> 5 years

Exclusion

  • Prior history of cancer other than basal or squamous cell skin cancer or in situ cancer of the cervix
  • Pregnant or breast feeding
  • Multicentric disease
  • Diagnosis of collagen vascular diseases, such as systemic lupus erythematosis, scleroderma, or dermatomyositis

Key Trial Info

Start Date :

December 1 2002

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2013

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT00290654

Start Date

December 1 2002

End Date

March 1 2013

Last Update

December 28 2017

Active Locations (1)

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Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States, 55455