Internal Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ
| Status: | Terminated |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/30/2017 |
| Start Date: | December 2002 |
| End Date: | March 2013 |
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.
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
- 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.
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.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
1
site
425 E River Pkwy # 754
Minneapolis, Minnesota 55455
Minneapolis, Minnesota 55455
612-624-2620
Masonic Cancer Center at University of Minnesota The Masonic Cancer Center was founded in 1991....
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