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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01644669
Registration number
NCT01644669
Ethics application status
Date submitted
28/06/2012
Date registered
19/07/2012
Date last updated
13/07/2023
Titles & IDs
Public title
Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT System®
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Scientific title
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
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Secondary ID [1]
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CTPR-0009
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Invasive Ductal Carcinoma
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Ductal Carcinoma in Situ
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Cervical (cervix)
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Cancer
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Breast
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Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Intra-operative Radiation Therapy - IORT
Experimental: Intra-operative Radiation Therapy - IORT - Intra-operative Radiation Therapy
Treatment: Other: Intra-operative Radiation Therapy - IORT
Single dose of 20 Gy
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Assess the rate of ipsilateral breast tumor recurrence (IBTR) at 5 years
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Assessment method [1]
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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.
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Timepoint [1]
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Change from baseline reported at 5 years
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Secondary outcome [1]
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Assess the rate of regional breast tumor recurrence (RBTR)
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Assessment method [1]
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Regional breast tumor recurrence is defined as biopsy-proven reappearance of cancer in the axilla. Regional recurrence will be assessed at Month 6, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. Regional recurrence rates will be compared to the historical control of WBI at 5 and 10 years.
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Timepoint [1]
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Report at 10 yrs
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Secondary outcome [2]
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Disease Free Survival Rate (DFSR) and Overall Survival rate
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Assessment method [2]
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Disease free survival (DFS) is defined as the length of time from IORT to any first recurrence. The incidence of disease free survival will be assessed at Month 1, Month 6, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. DFS will be compared to the historical control at 5 and 10 years.
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Timepoint [2]
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Report at 5 and 10 years
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Secondary outcome [3]
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Cosmetic Outcome
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Assessment method [3]
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Cosmetic outcome will be recorded at baseline, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. a. Physician evaluation will be done using the Harvard Scale.
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Timepoint [3]
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Report at 5 and 10 yrs
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Secondary outcome [4]
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Quality of Life (QOL)
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Assessment method [4]
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Quality of Life will be assessed at baseline and at each follow-up visit: Month 1, Month 6, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. QOL will be measured using the FACT-B self-reporting questionnaires.
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Timepoint [4]
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Reported at 5 and 10 yrs
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Secondary outcome [5]
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Assess the safety of single fraction IORT at the time of breast conserving surgery for early stage breast cancer
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Assessment method [5]
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The rates and severity of Adverse Events (AEs), Adverse Device Effects (ADEs), and Unanticipated Adverse Device Effects (UADEs) during and following IORT will be assessed at each follow-up visit. Safety events will be compared to the historical control of WBI at 5 and 10 years. Each event will be classified according to the following: Device Related, Procedure Related or Radiation Related.
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Timepoint [5]
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On-going monitoring, report at 5 and 10 years
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Secondary outcome [6]
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Assess the rate of ipsilateral breast tumor recurrence (IBTR) at 10 years
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Assessment method [6]
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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 10 years.
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Timepoint [6]
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Change from baseline reported at 10 years
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Eligibility
Key inclusion criteria
1. Subject must have provided written Informed Consent
2. Subject must have biopsy-proven invasive ductal carcinoma or ductal carcinoma in situ
of the breast
3. Subject must be female = 40 years of age
4. Subject's tumor(s) must be < 3.0 cm in greatest diameter by pre-operative assessment
5. Subject's tumor(s) must meet AJCC Tumor Classification: Tis, T1 or T2 (< 3 cm), N0, M0
6. Subject presenting with bilateral breast cancer may be enrolled if BOTH cancers meet
all of the inclusion and none of the exclusion criteria
7. Women of child-bearing potential must have a negative pregnancy test within one week
of IORT treatment
8. 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
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Subject is pregnant or nursing
2. Subject has significant auto-immune disease
3. Subject has a pacemaker present in the field of radiation or quadrant of the breast
cancer
4. Subject has biopsy-proven multifocal breast cancer
5. Subject has multi-centric breast cancer
6. Subject has known lympho-vascular invasion
7. Subject has invasive lobular cancer
8. Subject has undergone neo-adjuvant chemotherapy or neo-adjuvant endocrine therapy for
current breast cancer
9. Subject has a history of recurrent breast cancer in the ipsilateral breast
10. Subject has had previous radiation exposure of the involved breast
11. 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
12. Subject has contraindications for radiation
13. Subject considered by the Investigator to be high-risk for breast conservation surgery
and/or intra-operative radiation therapy
14. Subject has participated in any other clinical investigation that is likely to
confound study results or affect study outcome either at the time of IORT or for 3
months prior to IORT.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/05/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2029
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Actual
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Sample size
Target
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Accrual to date
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Final
1200
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Health / Peter MacCallum Cancer Centre - Clayton
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Recruitment postcode(s) [1]
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3165 - Clayton
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Colorado
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Country [4]
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United States of America
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State/province [4]
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Florida
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Country [5]
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United States of America
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State/province [5]
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Illinois
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Country [6]
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United States of America
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State/province [6]
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Indiana
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Country [7]
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United States of America
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State/province [7]
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Maryland
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Country [8]
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United States of America
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State/province [8]
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New Hampshire
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Country [9]
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United States of America
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State/province [9]
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New York
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Country [10]
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United States of America
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State/province [10]
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Oklahoma
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Country [11]
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United States of America
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State/province [11]
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Tennessee
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Country [12]
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United States of America
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State/province [12]
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Virginia
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Country [13]
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Portugal
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State/province [13]
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Porto
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Xoft, Inc.
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Icad, Inc.
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01644669
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Trial related presentations / publications
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.
Dickler 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.
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Public notes
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Contacts
Principal investigator
Name
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A.M. Nisar Syed, MD
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Address
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Long Beach Memorial Medical Center
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Phone
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Fax
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Email
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Contact person for public queries
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01644669
Download to PDF