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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: Active NA study of Ductal Carcinoma In Situ and Invasive Ductal Carcinoma, sponsored by Xoft.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
IBTR is defined as biopsy-proven reappearance of cancer in the treated breast. IBTR will be assessed at Month 6, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. A non-inferiority comparison to whole breast irradiation will be made at 5 years.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,200 participants |
| Start Date | 2012-05-08 |
| Est. Completion | 2029-12-31 |
| Phase | NA |
What the registry record for NCT01644669 still lists
NCT01644669 is an interventional study that assigns participants to a tested intervention. Its 1,200 participants enrollment target places it among the larger protocols in the corpus, above the 177-participant average among 15 other Ductal Carcinoma In Situ trials with a reported enrollment target (578% higher).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
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Where NCT01644669's enrollment target sits among peer trials
1,200 1st of 15 higher than 15 of 15 other Ductal Carcinoma In Situ trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ductal Carcinoma In Situ trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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