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

DCIS Clinical Trial

— DCIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00586326
• Other study ID #: MS-700
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2007
• Last updated: November 2, 2012
• Start date: August 2003
• Est. completion date: April 2011

Study information

• Verified date: November 2012
• Source: Hologic, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: April 2011
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating
• DCIS

Intervention

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.

Locations

Country	Name	City	State
United States	St. Agnes Hospital	Baltimore	Maryland
United States	MD Anderson Cancer Clinic	Houston	Texas
United States	Daniel Freeman Hospital	Inglewood	California
United States	University of Southern California	Los Angeles	California
United States	Cedars Medical Center	Miami Beach	Florida
United States	NY Presbyterian	New York	New York
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Arizona Oncology Services	Phoenix	Arizona
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Virginia Commonwealth University	Richmond	Virginia
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Swedish Cancer Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Hologic, Inc.	University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	Yes
Secondary	Overall Survival		At 5 Years	Yes
Secondary	Cause Specific Survival		At 5 Years	Yes
Secondary	Disease Free Survival		At 5 Years	Yes
Secondary	Cosmetic Evaluations Over Time	As assessed using the four category Harvard Scale for subjects with an evaluation at the 5 year timepoint	At 5 Years	No