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

University of Minnesota (UMN)

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer

Treatments: Procedure: Lumpectomy; Radiation: brachytherapy; Drug: Tamoxifen

Study type: Interventional

Funder types: Other

Identifiers

NCT00290654

UMN-0211M35761 (Other Identifier)

2002LS097

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 45 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Lumpectomy with Brachytherapy

Experimental group

Description:

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.

Treatment:

Procedure: Lumpectomy

Radiation: brachytherapy

Drug: Tamoxifen