Safety Study for Short-course Accelerated, Hypofractionated Partial Breast Radiotherapy (APBI) in Women With Early Stage Breast Cancer Using the Contura MLB
NCT01072838 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2013-06-17
Summary
To determine local disease control (recurrence) with shorter course of APBI delivered with a breast brachytherapy applicator.
Conditions
Interventions
- RADIATION
-
APBI (Dose Escalation)
Accelerated, hypofractionated partial breast radiotherapy. 3 dose schemes followed for 6 months each.
- DEVICE
-
Contura MLB Breast Brachytherapy Catheter
Sponsors & Collaborators
-
C. R. Bard
collaborator INDUSTRY -
SenoRx, Inc.
lead INDUSTRY
Principal Investigators
-
Atif Khan, MD · Rutgers Cancer Institute of New Jersey
-
Douglas W. Arthur, MD · Virginia Commonwealth University
-
Mihai Ghilezan, MD · William Beaumont Hospitals
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-12-31
- Primary Completion
- 2013-06-30
- Completion
- 2013-06-30
Countries
- United States
Study Locations
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