Clinical trial NCT00290654: Internal Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ
Official title: Twin Cities Brachytherapy Study for Ductal Carcinoma in Situ A Phase II Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: ductal breast carcinoma in situ
breast cancer in situ
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2006-02-13
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients With Ipsilateral Breast Tumor Recurrence
timeFrame: 1 year after treatment
measure: Number of Patients With Ipsilateral Breast Tumor Recurrence
timeFrame: 5 years after treatment
Secondary outcomes:
measure: Percentage of Patients Who Experienced Complications
timeFrame: within 6 months of treatment
measure: Percentage of Patients Who Experienced Complications
timeFrame: more than 6 months after treatment, for up to 5 years
measure: Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent
timeFrame: 6 months after treatment
measure: Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent
timeFrame: 12 months after treatment
measure: Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent
timeFrame: 6 months after treatment
measure: Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent
timeFrame: 12 months after treatment
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Todd M. Tuttle, MD
role: PRINCIPAL_INVESTIGATOR
References: