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NCT01644669 · ClinicalTrials.gov registry record · NA

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

A NA study of Ductal Carcinoma In Situ and Invasive Ductal Carcinoma, sponsored by Xoft.

Active
Registry status
NA
Development phase
1,200
Enrollment target
20
Study locations

NCT01644669 is a NA study of Ductal Carcinoma In Situ and Invasive Ductal Carcinoma that is active but no longer recruiting, run by Xoft. The registered enrollment target is 1,200 participants, above the 177-participant average among 15 other Ductal Carcinoma In Situ trials with a reported enrollment target (578% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT01644669, a NA study of Ductal Carcinoma In Situ and Invasive Ductal Carcinoma, is active but no longer recruiting, sponsored by Xoft.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
1,200 participants
Enrollment target
20
Study locations

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 Studied

Ductal Carcinoma In Situ Invasive Ductal Carcinoma

Interventions

  • RADIATION Intra-operative Radiation Therapy - IORT

Study Locations (20)

California

  • City of Hope - Duarte
  • Long Beach Memorial Medical Center - Long Beach
  • UCLA - Los Angeles
  • Tri-City Medical Center - Oceanside
  • Diablo Valley Oncology Hematology Medical Group - Pleasant Hill

Florida

  • Florida Hospital Celebration Health - Celebration
  • Doctors Hospital - Coral Gables
  • Martin Health System Center for Clinical Research - Stuart

Maryland

  • Greater Baltimore Medical Center - Baltimore
  • MedStar Oncology Network - Good Samaritan Hospital - Baltimore
  • MedStar Oncology Network - Franklin Square - Baltimore

Colorado

  • Western Surgical Care, PC - Denver
  • Swedish Medical Center - Englewood

Arizona

  • University of Arizona - Tucson

Illinois

  • Rush University - Chicago

Indiana

  • Lutheran Hospital of Indiana - Fort Wayne

New Hampshire

  • Exeter Hospital - Exeter

Trial Details

FieldValue
Enrollment Target 1,200 participants
Start Date 2012-05-08
Est. Completion 2029-12-31
Phase NA

Sponsor

Xoft

10 total trials

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What the Registry Record Tells You About NCT01644669

The ClinicalTrials.gov registry entry for NCT01644669 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 1,200 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 177-participant average among 15 other Ductal Carcinoma In Situ trials with a reported enrollment target (578% higher). The listed sponsor is Xoft, which has 10 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Ductal Carcinoma In Situ appearing as the primary indexed condition, and to 1 intervention - of which Intra-operative Radiation Therapy - IORT is the first listed.

NCT01644669 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, Maryland.

Frequently Asked Questions

What is clinical trial NCT01644669 about?

NCT01644669 is a clinical study titled "Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT System®". 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 radi...

What is the current status of trial NCT01644669?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,200 participants. The study started on 2012-05-08. Estimated completion is 2029-12-31.

What conditions does trial NCT01644669 study?

This clinical trial studies the following conditions: Ductal Carcinoma In Situ, Invasive Ductal Carcinoma.

What interventions are being tested in trial NCT01644669?

The interventions under investigation include: Intra-operative Radiation Therapy - IORT (RADIATION).

Who is sponsoring clinical trial NCT01644669?

This trial is sponsored by Xoft, which has 10 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01644669 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.