MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ (DCIS)
This study has been completed.
Sponsor:
Hologic, Inc.
Collaborator:
University of Southern California
Information provided by (Responsible Party):
Hologic, Inc.
ClinicalTrials.gov Identifier:
NCT00586326
First received: December 21, 2007
Last updated: November 2, 2012
Last verified: November 2012
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Purpose
This study has been designed to compile information on the efficacy of the MammoSite RTS providing sole radiation therapy for patients with pure DCIS.
| Condition | Intervention | Phase |
|---|---|---|
|
DCIS |
Device: MammoSite Radiation Therapy System |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | MammoSite Radiation Therapy System (RTS) as the Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ (DCIS) |
Resource links provided by NLM:
Further study details as provided by Hologic, Inc.:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: Yes ]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 [ Time Frame: At 5 Years ] [ Designated as safety issue: Yes ]
- Cause Specific Survival [ Time Frame: At 5 Years ] [ Designated as safety issue: Yes ]
- Disease Free Survival [ Time Frame: At 5 Years ] [ Designated as safety issue: Yes ]
- Cosmetic Evaluations Over Time [ Time Frame: At 5 Years ] [ Designated as safety issue: No ]As assessed using the four category Harvard Scale for subjects with an evaluation at the 5 year timepoint
| Enrollment: | 133 |
| Study Start Date: | August 2003 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Women with DCIS
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.
|
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| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00586326
Locations
| United States, Arizona | |
| Arizona Oncology Services | |
| Phoenix, Arizona, United States, 85032 | |
| United States, California | |
| Daniel Freeman Hospital | |
| Inglewood, California, United States, 90301 | |
| University of Southern California | |
| Los Angeles, California, United States, 90033 | |
| United States, Florida | |
| Cedars Medical Center | |
| Miami Beach, Florida, United States, 33136 | |
| United States, Maryland | |
| St. Agnes Hospital | |
| Baltimore, Maryland, United States, 21229 | |
| United States, Michigan | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, New York | |
| NY Presbyterian | |
| New York, New York, United States, 10065 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, Texas | |
| MD Anderson Cancer Clinic | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Virginia Commonwealth University | |
| Richmond, Virginia, United States, 23298 | |
| United States, Washington | |
| Swedish Cancer Institute | |
| Seattle, Washington, United States, 98104 | |
Sponsors and Collaborators
Hologic, Inc.
University of Southern California
Investigators
| Principal Investigator: | Oscar Streeter, MD | University of Southern California |
More Information
No publications provided
| Responsible Party: | Hologic, Inc. |
| ClinicalTrials.gov Identifier: | NCT00586326 History of Changes |
| Other Study ID Numbers: | MS-700 |
| Study First Received: | December 21, 2007 |
| Results First Received: | September 20, 2012 |
| Last Updated: | November 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Hologic, Inc.:
|
MammoSite DCIS |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Carcinoma, Ductal Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary Breast Neoplasms Neoplasms by Site Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013