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

Primary Purpose

DCIS

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MammoSite Radiation Therapy System
Sponsored by
Hologic, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for DCIS focused on measuring MammoSite, DCIS

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Oncology Services
  • Daniel Freeman Hospital
  • University of Southern California
  • Cedars Medical Center
  • St. Agnes Hospital
  • William Beaumont Hospital
  • NY Presbyterian
  • Fox Chase Cancer Center
  • Rhode Island Hospital
  • MD Anderson Cancer Clinic
  • Virginia Commonwealth University
  • Swedish Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Women with DCIS

Arm Description

Women with DCIS

Outcomes

Primary Outcome Measures

Local Control Rate for Follow-up Period of 5 Years.
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.

Secondary Outcome Measures

Overall Survival
Cause Specific Survival
Disease Free Survival
Cosmetic Evaluations Over Time
As assessed using the four category Harvard Scale for subjects with an evaluation at the 5 year timepoint

Full Information

First Posted
December 21, 2007
Last Updated
November 2, 2012
Sponsor
Hologic, Inc.
Collaborators
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT00586326
Brief Title
MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ
Acronym
DCIS
Official Title
MammoSite Radiation Therapy System (RTS) as the Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ (DCIS)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hologic, Inc.
Collaborators
University of Southern California

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DCIS
Keywords
MammoSite, DCIS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Women with DCIS
Arm Type
Experimental
Arm Description
Women with DCIS
Intervention Type
Device
Intervention Name(s)
MammoSite Radiation Therapy System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Local Control Rate for Follow-up Period of 5 Years.
Description
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.
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.
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
At 5 Years
Title
Cause Specific Survival
Time Frame
At 5 Years
Title
Disease Free Survival
Time Frame
At 5 Years
Title
Cosmetic Evaluations Over Time
Description
As assessed using the four category Harvard Scale for subjects with an evaluation at the 5 year timepoint
Time Frame
At 5 Years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar Streeter, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Oncology Services
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Daniel Freeman Hospital
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
St. Agnes Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
NY Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
MD Anderson Cancer Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

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

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