Clinical trial NCT00586326: MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ
Official title: MammoSite Radiation Therapy System (RTS) as the Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ (DCIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: DCIS
Keywords: MammoSite
DCIS
Lead sponsor: Hologic, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Southern California
First posted: 2008-01-04
Enrollment: 133
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study has been designed to compile information on the efficacy of the MammoSite RTS providing sole radiation therapy for patients with pure DCIS.

Detailed description: Data relevant to the evaluation of the efficacy and safety of the MammoSite RTS system in providing radiation therapy to patients with DCIS will be collected. The MammoSite is a radionuclide applicator designed to deliver internal radiation therapy (brachytherapy) in patients with breast tumors following breast tumor resection surgery (lumpectomy).

Eligibility criteria: Inclusion Criteria:

* Pre-Surgery:

  * Unicentric pure DCIS
  * Lesions should have a greatest dimension of 3 cm or less as determined by pre-surgery mammography and MRI
* Post-Surgery:

  * Negative histological margins confirmed prior to beginning radiation therapy.
  * Margins are positive if there is tumor at the inked margin.
  * Classified as low (NG1), intermediate (NG2) or high (NG3) nuclear grade DCIS, using the Philadelphia Consensus Conference Guidelines are eligible
  * Clinically node negative

Exclusion Criteria:

* Distance from the balloon surface to the surface of the skin \< 5mm as determined by CT imaging.
* Distant metastases.
* Invasive or in-situ lobular carcinoma (post-surgery assessment).
* Nonepithelial breast malignancies such as sarcoma or lymphoma.
* DCIS that is multicentric in the ipsilateral breast.
* Pregnant or lactating.
* Prior non-hormonal therapy for the present breast cancer, including radiation therapy and/or chemotherapy.
* Collagen vascular diseases
* Coexisting medical conditions with life expectancy \< 2 years.
* Serious psychiatric or addictive disorder
* Previously treated contralateral breast carcinoma
* Synchronous bilateral breast carcinoma.
* Other malignancy, except non-melanoma skin cancer, \< 5 years prior to participation in the study; the disease free interval from any prior carcinoma must be continuous.
* Patients with diffuse disease

Primary outcomes:
measure: Local Control Rate for Follow-up Period of 5 Years.
timeFrame: Data collected at the time of implant, radiation therapy, and at the patient's 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year follow-up visits.
Secondary outcomes:
measure: Overall Survival
timeFrame: At 5 Years
measure: Cause Specific Survival
timeFrame: At 5 Years
measure: Disease Free Survival
timeFrame: At 5 Years
measure: Cosmetic Evaluations Over Time
timeFrame: At 5 Years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Oncology Services
state: Arizona
city: Inglewood
country: United States
facility: Daniel Freeman Hospital
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Miami Beach
country: United States
facility: Cedars Medical Center
state: Florida
city: Baltimore
country: United States
facility: St. Agnes Hospital
state: Maryland
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: New York
country: United States
facility: NY Presbyterian
state: New York
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Houston
country: United States
facility: MD Anderson Cancer Clinic
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
Study officials:
affiliation: University of Southern California
name: Oscar Streeter, MD
role: PRINCIPAL_INVESTIGATOR
References: