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


Phase 2
45 Years
N/A
Not Enrolling
Female
DCIS

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Trial Information

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


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).


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome 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.

Outcome 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.

Safety Issue:

Yes

Principal Investigator

Oscar Streeter, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern California

Authority:

United States: Food and Drug Administration

Study ID:

MS-700

NCT ID:

NCT00586326

Start Date:

August 2003

Completion Date:

April 2011

Related Keywords:

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

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Rhode Island HospitalProvidence, Rhode Island  02903
Swedish Cancer InstituteSeattle, Washington  98104
William Beaumont HospitalRoyal Oak, Michigan  48073
Cedars Medical CenterMiami, Florida  33136
Virginia Commonwealth UniversityRichmond, Virginia  
University of Southern CaliforniaLos Angeles, California  90033
St. Agnes HospitalBaltimore, Maryland  21229
Arizona Oncology ServicesPhoenix, Arizona  85032
Daniel Freeman HospitalInglewood, California  90301
NY PresbyterianNew York, New York  10065
MD Anderson Cancer ClinicHouston, Texas  77030