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Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT System®

NCT01644669 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2025-01-31

No results posted yet for this study

Summary

The purpose of this trial is to assess the safety and efficacy of the Xoft Axxent eBx System when used for single-fraction IORT in early stage breast cancer. Hypothesis: IORT using the Xoft Axxent eBx System is no worse (non-inferior) than whole breast irradiation (WBI) when used as stand-alone radiation treatment in breast conserving therapy in women with early stage breast cancer.

Conditions

  • Invasive Ductal Carcinoma
  • Ductal Carcinoma in Situ

Interventions

RADIATION

Intra-operative Radiation Therapy - IORT

Single dose of 20 Gy

Sponsors & Collaborators

  • Icad, Inc.

    collaborator INDUSTRY

  • Xoft, Inc.

    lead INDUSTRY

Principal Investigators

  • A.M. Nisar Syed, MD · Long Beach Memorial Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-08
Primary Completion
2023-07-12
Completion
2029-12-31

Countries

  • United States
  • Australia
  • Portugal

Study Locations

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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 NCT01644669 on ClinicalTrials.gov