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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01644669




Registration number
NCT01644669
Ethics application status
Date submitted
28/06/2012
Date registered
19/07/2012
Date last updated
16/04/2020

Titles & IDs
Public title
Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT System®
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
Secondary ID [1] 0 0
CTPR-0009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Invasive Ductal Carcinoma 0 0
Ductal Carcinoma in Situ 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Cervical (cervix)
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Change from baseline reported at 5 years
Secondary outcome [1] 0 0
Assess the rate of regional breast tumor recurrence (RBTR) - 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.
Timepoint [1] 0 0
Report at 10 yrs
Secondary outcome [2] 0 0
Disease Free Survival Rate (DFSR) and Overall Survival rate - 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.
Timepoint [2] 0 0
Report at 5 and 10 years
Secondary outcome [3] 0 0
Cosmetic Outcome - 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.
Timepoint [3] 0 0
Report at 5 and 10 yrs
Secondary outcome [4] 0 0
Quality of Life (QOL) - 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.
Timepoint [4] 0 0
Reported at 5 and 10 yrs
Secondary outcome [5] 0 0
Assess the safety of single fraction IORT at the time of breast conserving surgery for early stage breast cancer - 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.
Timepoint [5] 0 0
On-going monitoring, report at 5 and 10 years
Secondary outcome [6] 0 0
Assess the rate of ipsilateral breast tumor recurrence (IBTR) at 10 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 10 years.
Timepoint [6] 0 0
Change from baseline reported at 10 years

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
Minimum age
40 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Health / Peter MacCallum Cancer Centre - Clayton
Recruitment postcode(s) [1] 0 0
3165 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
New Hampshire
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
Portugal
State/province [13] 0 0
Porto

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Xoft, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Icad, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01644669
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.
Public notes

Contacts
Principal investigator
Name 0 0
Helena Chang, MD, PhD
Address 0 0
University of California, Los Angeles
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications