Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT System®
A Safety and Efficacy Study of Intra-Operative Radiation Therapy (IORT) Using the Xoft® Axxent® eBx® System® at the Time of Breast Conservation Surgery for Early Stage Breast Cancer
1 other identifier
interventional
1,200
3 countries
24
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2012
Longer than P75 for not_applicable
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 8, 2012
CompletedFirst Submitted
Initial submission to the registry
June 28, 2012
CompletedFirst Posted
Study publicly available on registry
July 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
ExpectedJanuary 31, 2025
January 1, 2025
11.2 years
June 28, 2012
January 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Assess the rate of ipsilateral breast tumor recurrence (IBTR) at 5 years
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.
Change from baseline reported at 5 years
Secondary Outcomes (6)
Assess the rate of regional breast tumor recurrence (RBTR)
Report at 10 yrs
Disease Free Survival Rate (DFSR) and Overall Survival rate
Report at 5 and 10 years
Cosmetic Outcome
Report at 5 and 10 yrs
Quality of Life (QOL)
Reported at 5 and 10 yrs
Assess the safety of single fraction IORT at the time of breast conserving surgery for early stage breast cancer
On-going monitoring, report at 5 and 10 years
- +1 more secondary outcomes
Study Arms (1)
Intra-operative Radiation Therapy - IORT
EXPERIMENTALIntra-operative Radiation Therapy
Interventions
Single dose of 20 Gy
Eligibility Criteria
You may qualify if:
- Subject must have provided written Informed Consent
- Subject must have biopsy-proven invasive ductal carcinoma or ductal carcinoma in situ of the breast
- Subject must be female ≥ 40 years of age
- Subject's tumor(s) must be \< 3.0 cm in greatest diameter by pre-operative assessment
- Subject's tumor(s) must meet AJCC Tumor Classification: Tis, T1 or T2 (\< 3 cm), N0, M0
You may not qualify if:
- Women of child-bearing potential must have a negative pregnancy test within one week of IORT treatment
- Women of child-bearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives or a combination of condom and spermicide) from the time of negative pregnancy test through completion of the radiation treatment period
- Subject is pregnant or nursing
- Subject has significant auto-immune disease
- Subject has a pacemaker present in the field of radiation or quadrant of the breast cancer
- Subject has biopsy-proven multifocal breast cancer
- Subject has multi-centric breast cancer
- Subject has known lympho-vascular invasion
- Subject has invasive lobular cancer
- Subject has undergone neo-adjuvant chemotherapy or neo-adjuvant endocrine therapy for current breast cancer
- Subject has a history of recurrent breast cancer in the ipsilateral breast
- Subject has had previous radiation exposure of the involved breast
- Subject has BRCA 1 or 2 mutations. Note: Testing will only be required for Subjects presenting with bilateral breast cancer; testing is not required for unilateral cancers
- Subject has contraindications for radiation
- Subject considered by the Investigator to be high-risk for breast conservation surgery and/or intra-operative radiation therapy
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xoft, Inc.lead
- Icad, Inc.collaborator
Study Sites (24)
University of Arizona
Tucson, Arizona, 85704, United States
City of Hope
Duarte, California, 91010, United States
Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
UCLA
Los Angeles, California, 90095, United States
Tri-City Medical Center
Oceanside, California, 92056, United States
Diablo Valley Oncology Hematology Medical Group
Pleasant Hill, California, 94523, United States
Western Surgical Care, PC
Denver, Colorado, 80220, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Florida Hospital Celebration Health
Celebration, Florida, 34747, United States
Doctors Hospital
Coral Gables, Florida, 33146, United States
Martin Health System Center for Clinical Research
Stuart, Florida, 34994, United States
Rush University
Chicago, Illinois, 60612, United States
Lutheran Hospital of Indiana
Fort Wayne, Indiana, 46804, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
MedStar Oncology Network - Good Samaritan Hospital
Baltimore, Maryland, 21218, United States
MedStar Oncology Network - Franklin Square
Baltimore, Maryland, 21237, United States
Exeter Hospital
Exeter, New Hampshire, 03833, United States
Staten Island University Hospital
Staten Island, New York, 10305, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Parkridge Medical Center
Chattanooga, Tennessee, 37404, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37212, United States
Sentara Northern Virginia Medical Center
Woodbridge, Virginia, 22191, United States
Monash Health / Peter MacCallum Cancer Centre
Clayton, Victoria, 3165, Australia
Hospital CUF Porto
Porto, Portugal
Related Publications (2)
Ivanov O, Dickler A, Lum BY, Pellicane JV, Francescatti DS. Twelve-month follow-up results of a trial utilizing Axxent electronic brachytherapy to deliver intraoperative radiation therapy for early-stage breast cancer. Ann Surg Oncol. 2011 Feb;18(2):453-8. doi: 10.1245/s10434-010-1283-x. Epub 2010 Aug 25.
PMID: 20737219BACKGROUNDDickler A, Ivanov O, Francescatti D. Intraoperative radiation therapy in the treatment of early-stage breast cancer utilizing xoft axxent electronic brachytherapy. World J Surg Oncol. 2009 Mar 2;7:24. doi: 10.1186/1477-7819-7-24.
PMID: 19254369BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
A.M. Nisar Syed, MD
Long Beach Memorial Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2012
First Posted
July 19, 2012
Study Start
May 8, 2012
Primary Completion
July 12, 2023
Study Completion (Estimated)
December 31, 2029
Last Updated
January 31, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share
No IPD will be shared.