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Post Market Clinical Study to Evaluate the Safety and Performance of the Axxent® Electronic Brachytherapy System in Women With Resected, Early Stage Breast Cancer


Phase 4
50 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Post Market Clinical Study to Evaluate the Safety and Performance of the Axxent® Electronic Brachytherapy System in Women With Resected, Early Stage Breast Cancer


The purpose of this multi-center clinical study is to compile post market performance and
safety data on the Axxent System for the delivery of radiation therapy as part of breast
conserving therapy in women with resected, early stage breast cancer.


Inclusion Criteria:



- Age >50 years

- Tumor with Tis, T1, N0, M0 - (AJC Classification)

- Invasive ductal carcinoma or ductal carcinoma in situ

- Negative microscopic surgical margins of at least 1mm in all directions

- Adequate skin spacing between balloon surface and surface of the skin - (> 7mm)

Exclusion Criteria:

- Pregnancy or breast-feeding - (During the treatment portion of the study, sexually
active women of childbearing age will be asked to use pregnancy prevention)

- Scleroderma, systemic sclerosis and active lupus

- Infiltrating lobular histology

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants With Delivery of 34 Gy in 10 Fractions

Outcome Description:

Successful delivery of the radiation treatment defined as a total 34 Gy in a total of 10 fractions, 3.4 Gy per fraction. (Gray = GY is a measure of radiation dose delivered to tissue)

Outcome Time Frame:

measured at end of 10th fraction, usually within 7 days

Safety Issue:

No

Principal Investigator

Vivek K Mehta, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Swedish Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

1-04

NCT ID:

NCT01017549

Start Date:

March 2007

Completion Date:

March 2013

Related Keywords:

  • Breast Cancer
  • Stage I
  • Stage II
  • Breast
  • Cancer
  • Breast Neoplasms

Name

Location

Rhode Island HospitalProvidence, Rhode Island  02903
Beth Israel Medical CenterNew York, New York  10003
Swedish Cancer InstituteSeattle, Washington  98104
Rush University Medical CenterChicago, Illinois  60612-3824
Oklahoma University Health Science CenterOklahoma City, Oklahoma  73104
Mills Peninsula HospitalSan Mateo, California  94401
Wellstar-Kennestone Cancer CenterMarietta, Georgia  30060
Little Company of Mary HospitalEvergreen Park, Illinois  60805
Holy Cross Medical CenterSilver Spring, Maryland  20910
Dickstein Cancer Center- White Plains HospitalWhite Plains, New York  10601