Internal Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ
NCT ID: NCT00290654
Last Updated: 2017-12-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
45 participants
INTERVENTIONAL
2002-12-31
2013-03-31
Brief Summary
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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
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient
Lumpectomy
A standard lumpectomy will be performed with an attempt to remove at least 1 cm of gross margin around the DCIS.
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.
Interventions
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Tamoxifen
Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient
Lumpectomy
A standard lumpectomy will be performed with an attempt to remove at least 1 cm of gross margin around the DCIS.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant or breast feeding
* Multicentric disease
* Diagnosis of collagen vascular diseases, such as systemic lupus erythematosis, scleroderma, or dermatomyositis
18 Years
FEMALE
No
Sponsors
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Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Todd M. Tuttle, MD
Role: PRINCIPAL_INVESTIGATOR
Masonic Cancer Center, University of Minnesota
Locations
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Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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UMN-0211M35761
Identifier Type: OTHER
Identifier Source: secondary_id
2002LS097
Identifier Type: -
Identifier Source: org_study_id