MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ (DCIS)

November 2, 2012 updated by: Hologic, Inc.

MammoSite Radiation Therapy System (RTS) as the Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ (DCIS)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Arizona Oncology Services
    • California
      • Inglewood, California, United States, 90301
        • Daniel Freeman Hospital
      • Los Angeles, California, United States, 90033
        • University of Southern California
    • Florida
      • Miami Beach, Florida, United States, 33136
        • Cedars Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • St. Agnes Hospital
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • New York
      • New York, New York, United States, 10065
        • NY Presbyterian
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Clinic
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Women with DCIS
Device: MammoSite Radiation Therapy System
The MammoSite is a balloon catheter that is designed to position a radioactive source inside the lumpectomy cavity. The MammoSite applicator is inserted into the cavity created by the tumor removal surgery. The MammoSite applicator is then inflated and expands to fill the cavity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Control Rate for Follow-up Period of 5 Years.
Time Frame: 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.
Failure of local control was defined as a histologically confirmed recurrence (invasive or non-invasive) within the prescription isodose volume. All recurrences were to have histological evaluation per the protocol; however, the case report forms did not provide space for this data to be captured. Ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrence or distant metastases were not considered treatment failures unless accompanied by ipsilateral breast failure.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: At 5 Years
At 5 Years
Cause Specific Survival
Time Frame: At 5 Years
At 5 Years
Disease Free Survival
Time Frame: At 5 Years
At 5 Years
Cosmetic Evaluations Over Time
Time Frame: At 5 Years
As assessed using the four category Harvard Scale for subjects with an evaluation at the 5 year timepoint
At 5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hologic, Inc.

Collaborators

University of Southern California

Investigators

  • Principal Investigator: Oscar Streeter, MD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

January 4, 2008

Study Record Updates

Last Update Posted (Estimate)

November 6, 2012

Last Update Submitted That Met QC Criteria

November 2, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-700

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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