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Electronic Xoft Intersociety Brachytherapy Trial


Phase 4
50 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Carcinoma, Lumpectomy, Ductal Carcinoma in Situ

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Trial Information

Electronic Xoft Intersociety Brachytherapy Trial


Inclusion Criteria:



- Patient 50 years of age or older

- Estrogen receptor positive

- Tumor size ≤ 3cm

- Tumor histology: invasive carcinoma or DCIS

- Patient is node negative

- Patient has negative surgical margins (NSABP definition, no tumor on ink) after final
surgery

- Life expectancy > 5 years

Exclusion Criteria:

- Pregnancy or breast-feeding. (If appropriate, patient must use birth control during
the registry.) The need for a pregnancy test is based on the physician's standard
practice and will be performed according to the physician's standard of care.

- Collagen Vascular Disease

- Scleroderma

- Systemic sclerosis

- Active lupus

- Infiltrating lobular histology

- Previous ipsilateral radiation to the thorax or breast

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The incidence of signs and symptoms of subcutaneous toxicities will be recorded at the following follow-up visits; six month, one year, two year, three year, four year, and five year.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Peter Beitsch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dallas Surgical Group

Authority:

United States: Institutional Review Board

Study ID:

TPR-0186

NCT ID:

NCT00742222

Start Date:

May 2008

Completion Date:

January 2015

Related Keywords:

  • Breast Cancer
  • Carcinoma
  • Lumpectomy
  • Ductal Carcinoma In Situ
  • Electronic brachytherapy registry
  • Multi-society registry
  • Breast cancer registry
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal, Breast
  • Carcinoma, Ductal

Name

Location
Florida Radiation Oncology Group Orange Park, Florida  32073
DCH Cancer Treatment Center Tuscaloosa, Alabama  35401
Cancer Institute of Cape Girardeau Cape Girardeau, Missouri  63703
University of South Florida Tampa, Florida  33612
Beth Israel New York, New York  10003
Beverly Oncology Montebello, California  90640
St Elizabeth's and Memorial Cancer Center Swansea, Illinois  62226
Brockton Hospital Signature Health Brockton, Massachusetts  02302
Shields Radiation Oncology Quincy, Massachusetts  02619
AtlantiCare Cancer Care Institute Galloway, New Jersey  08205
Nazha Cancer Center Northfield, New Jersey  08225
Dallas Surgical Group / Northpoint Cancer Center Dallas, Texas  75230