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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01072838 on ClinicalTrials.gov