Breast CancerNCT01017549
Post Market Study Using the Xoft Axxent System
A study testing Electronic brachytherapy (Axxent System) in people with Breast Cancer, run by Xoft, Inc. at 10 sites in United States.
Trial summary
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Electronic brachytherapy (Axxent System)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 10 sitesUnited States
- Study dates
- 26 Mar 2007to 7 May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >50 years
- Tumor with Tis, T1, N0, M0 - (AJC Classification)
- Invasive ductal carcinoma or ductal carcinoma in situ
- Negative microscopic surgical margins of at least 1mm in all directions
- Adequate skin spacing between balloon surface and surface of the skin - (> 7mm)
Who cannot join
- Pregnancy or breast-feeding - (During the treatment portion of the study, sexually active women of childbearing age will be asked to use pregnancy prevention)
- Scleroderma, systemic sclerosis and active lupus
- Infiltrating lobular histology
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Rush University Medical Center
Chicago, Illinois, 60612
Little Company of Mary Hospital
Evergreen Park, Illinois, 60805
Wellstar-Kennestone Cancer Center
Marietta, Georgia, 30060
Beth Israel Medical Center
New York, New York, 10003
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, 73104
Rhode Island Hospital
Providence, Rhode Island, 02903
Mills Peninsula Hospital
San Mateo, California, 94401
Swedish Cancer Institute
Seattle, Washington, 98104
Holy Cross Medical Center
Silver Spring, Maryland, 20910
Dickstein Cancer Center- White Plains Hospital
White Plains, New York, 10601
About this study
Official title: Post Market Clinical Study to Evaluate the Safety and Performance of the Axxent® Electronic Brachytherapy System in Women With Resected, Early Stage Breast Cancer
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System.
Read the detailed description
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System for the delivery of radiation therapy as part of breast conserving therapy in women with resected, early stage breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Electronic brachytherapy (Axxent System)
- Keywords
- Stage I, Stage II, Breast, Cancer
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic brachytherapy (Axxent System)Radiation
Also called Radiation therapy, Axxent, Xoft, eBx, EBT, brachytherapy
3.4 Gy per fraction for 10 fractions for a total of 34 Gy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | This is a single arm study where all patients are treated with FDA cleared electronic brachytherapy treatment. Receives: Radiation: Electronic brachytherapy (Axxent System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Delivery of 34 Gy in 10 Fractions
Successful delivery of the radiation treatment defined as a total 34 Gy in a total of 10 fractions, 3.4 Gy per fraction. (Gray = GY is a measure of radiation dose delivered to tissue)
Measured: measured at end of 10th fraction, usually within 7 days
Secondary outcomes (1)
Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up.
Serious adverse device related events reported from treatment through 6 month follow-up and at 5-year follow-up are reported.
Measured: Through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study start26 Mar 2007
- Primary completion6 Jun 2013
- Study completion7 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xoft, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vivek K Mehta, MD, Principal investigator, Swedish Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017549
- Sponsor's protocol ID
- 1-04
- Status last verified
- Aug 2020
- First submitted
- 18 Nov 2009
- Last updated
- 13 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mehta VK, Algan O, Griem KL, Dickler A, Haile K, Wazer DE, Stevens RE, Chadha M, Kurtzman S, Modin SD, Dowlatshahi K, Elliott KW, Rusch TW. Experience with an electronic brachytherapy technique for intracavitary accelerated partial breast irradiation. Am J Clin Oncol. 2010 Aug;33(4):327-35. doi: 10.1097/COC.0b013e3181d79d9e.
PubMed 20375833
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Study to Evaluate the Safety and Performance of the Axxent® Electronic Brachytherapy System in Women With Resected, Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT01017549
- Acronym / sponsor ID
- 1-04
- Conditions
- Breast Cancer
- Keywords
- Stage I, Stage II, Breast, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Xoft, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Mar 2007 (actual)
- Primary completion
- 6 Jun 2013 (actual)
- Study completion
- 7 May 2016 (actual)
- First posted
- 20 Nov 2009 (estimated)
- Results
- Posted 11 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System.
Detailed description
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System for the delivery of radiation therapy as part of breast conserving therapy in women with resected, early stage breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Radiation: Electronic brachytherapy (Axxent System)This is a single arm study where all patients are treated with FDA cleared electronic brachytherapy treatment. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >50 years
- Tumor with Tis, T1, N0, M0 - (AJC Classification)
- Invasive ductal carcinoma or ductal carcinoma in situ
- Negative microscopic surgical margins of at least 1mm in all directions
- Adequate skin spacing between balloon surface and surface of the skin - (> 7mm)
Key exclusion criteria (3 listed)
- Pregnancy or breast-feeding - (During the treatment portion of the study, sexually active women of childbearing age will be asked to use pregnancy prevention)
- Scleroderma, systemic sclerosis and active lupus
- Infiltrating lobular histology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic brachytherapy (Axxent System)Also: Radiation therapy, Axxent, Xoft, eBx, EBT, brachytherapy3.4 Gy per fraction for 10 fractions for a total of 34 Gy. | Radiation | Treatment |
Primary outcome
Number of Participants With Delivery of 34 Gy in 10 Fractions
Time frame: measured at end of 10th fraction, usually within 7 days
Successful delivery of the radiation treatment defined as a total 34 Gy in a total of 10 fractions, 3.4 Gy per fraction. (Gray = GY is a measure of radiation dose delivered to tissue)
1 secondary outcome
Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up.
Time frame: Through 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20375833Mehta VK, Algan O, Griem KL, Dickler A, Haile K, Wazer DE, Stevens RE, Chadha M, Kurtzman S, Modin SD, Dowlatshahi K, Elliott KW, Rusch TW. Experience with an electronic brachytherapy technique for intracavitary accelerated partial breast irradiation. Am J Clin Oncol. 2010 Aug;33(4):327-35. doi: 10.1097/COC.0b013e3181d79d9e.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivek K Mehta, MD principal investigator
Swedish Cancer Institute
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic brachytherapy (Axxent System) in people with Breast Cancer, run by Xoft, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Delivery of 34 Gy in 10 Fractions (time frame: measured at end of 10th fraction, usually within 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01017549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.