Cervical CancerNCT01851772
Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer
A study testing Treatment with Electronic Brachytherapy in people with Cervical Cancer, run by Xoft, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, performance and usability of the Xoft Axxent Electronic Brachytherapy System and Cervical Applicator as incorporated into the physician's current standard treatment practice and in replacement of high-dose-rate after-loaders using Iridium-192 or low-dose-rate Cesium… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Treatment with Electronic Brachytherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jun 2015
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Brachytherapy is indicated after EBRT for all cases of locally advanced disease (Stages Ib2 - IVA)
- Inoperable Stage Ia1 and Stage Ia2 may be treated with tandem-based brachytherapy alone
- Inoperable Stage Ib1 should be treated radically with brachytherapy in conjunction with EBRT. Concurrent chemotherapy may be considered at the physician's discretion and based on the presence of high risk features.
- Subjects can be treated with brachytherapy regardless of lymph node status, grade, and presence of lymphovascular invasion, tumor size, age, or histology.
- Medically fit for general or spinal anesthesia, or conscious sedation, for the insertion process
- Subjects of childbearing potential must have a negative serum pregnancy test at Screening inclusion Criteria:
Who cannot join
- Medical Contraindications to Brachytherapy (scleroderma, collagen vascular disease, active lupus )
- Prior pelvic radiotherapy with brachytherapy
- Hemoglobin level at screening < 8
- Life expectancy < 6 months
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the safety, performance and usability of the Xoft Axxent Electronic Brachytherapy System and Cervical Applicator as incorporated into the physician's current standard treatment practice and in replacement of high-dose-rate after-loaders using Iridium-192 or low-dose-rate Cesium treatments. Data will be collected on treatment delivery, safety, and acute toxicity.
Our hypothesis is that the treatment is safe as incorporated into the physician's current standard of practice.
- Conditions
- Cervical Cancer
- Being tested
- Treatment with Electronic Brachytherapy
- Keywords
- cervical, cancer, brachytherapy, electronic, device, applicator, toxicity, gynecologic, high-dose-rate (HDR), x-ray, safety, external beam radiation therapy (EBRT)
- Medical subject headings
- Uterine Cervical Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with Electronic BrachytherapyDevice
Also called Xoft®, Axxent®, Electronic, Brachytherapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects enrolled will undergo brachytherapy treatment in combination with EBRT. The maximum length of treatment will be 56 days. The treating physician will determine the appropriate course of treatment based on the physician's current practice or experience using Iridium-192 or Cesium HDR after-loaders to administer cervical brachytherapy treatments.
Subjects enrolled will be treated with approximately 80-90 Gy total treatment dose over 4-6 fractions. Examples of commonly used dose regimens in the US are listed in section 7.6.7. This study will include data collection from the initiation of EBRT through administration of the final Xoft Axxent treatment fraction, and at one (1) month and three (3) months. Receives: Device: Treatment with Electronic Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Adverse Event Rate and Severity
Adverse event rate and severity during and following the administration of brachytherapy treatment, through discharge from the treatment facility, and for 3 months after treatment.
Measured: Study Exit (90 days)
Secondary outcomes (1)
Device Performance
Number of subjects who received complete delivery of the brachytherapy treatment using the Xoft Electronic Brachytherapy System with the cervical applicator.
Measured: Study Exit (90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2015
- Study completionJun 2015
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.
- Other trials for Cervical 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xoft, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Icad, Inc.
- Responsible party
- Sponsor
- Investigators
- Lowndes Harrison, MD, Principal investigator, Gadsden Regional Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851772
- Sponsor's protocol ID
- CTRP-0010
- Status last verified
- Nov 2015
- First submitted
- 7 May 2013
- Last updated
- 12 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer
- ClinicalTrials.gov ID
- NCT01851772
- Acronym / sponsor ID
- CTRP-0010
- Conditions
- Cervical Cancer
- Keywords
- cervical, cancer, brachytherapy, electronic, device, applicator, toxicity, gynecologic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Xoft, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Icad, Inc.
- Study start
- Nov 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 May 2013 (estimated)
- Results
- Posted 24 Jun 2016
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 study is to evaluate the safety, performance and usability of the Xoft Axxent Electronic Brachytherapy System and Cervical Applicator as incorporated into the physician's current standard treatment practice and in replacement of high-dose-rate after-loaders using Iridium-192 or low-dose-rate Cesium treatments. Data will be collected on treatment delivery, safety, and acute toxicity.
Our hypothesis is that the treatment is safe as incorporated into the physician's current standard of practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Treatment with Electronic BrachytherapySubjects enrolled will undergo brachytherapy treatment in combination with EBRT. The maximum length of treatment will be 56 days. The treating physician will determine the appropriate course of treatment based on the physician's current practice or experience using Iridium-192 or Cesium HDR after-loaders to administer cervical brachytherapy treatments. Subjects enrolled will be treated with approximately 80-90 Gy total treatment dose over 4-6 fractions. Examples of commonly used dose regimens in the US are listed in section 7.6.7. This study will include data collection from the initiation of EBRT through administration of the final Xoft Axxent treatment fraction, and at one (1) month and three (3) months. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Brachytherapy is indicated after EBRT for all cases of locally advanced disease (Stages Ib2 - IVA)
- Inoperable Stage Ia1 and Stage Ia2 may be treated with tandem-based brachytherapy alone
- Inoperable Stage Ib1 should be treated radically with brachytherapy in conjunction with EBRT. Concurrent chemotherapy may be considered at the physician's discretion and based on the presence of high risk features.
- Subjects can be treated with brachytherapy regardless of lymph node status, grade, and presence of lymphovascular invasion, tumor size, age, or histology.
- Medically fit for general or spinal anesthesia, or conscious sedation, for the insertion process
Key exclusion criteria (4 listed)
- Medical Contraindications to Brachytherapy (scleroderma, collagen vascular disease, active lupus )
- Prior pelvic radiotherapy with brachytherapy
- Hemoglobin level at screening < 8
- Life expectancy < 6 months
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 |
|---|---|---|
| Treatment with Electronic BrachytherapyAlso: Xoft®, Axxent®, Electronic, Brachytherapy | Device | Treatment |
Primary outcome
Safety - Adverse Event Rate and Severity
Time frame: Study Exit (90 days)
Adverse event rate and severity during and following the administration of brachytherapy treatment, through discharge from the treatment facility, and for 3 months after treatment.
1 secondary outcome
Device Performance
Time frame: Study Exit (90 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Lowndes Harrison, MD principal investigator
Gadsden Regional Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with Electronic Brachytherapy in people with Cervical Cancer, run by Xoft, Inc. at 1 site 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 6 inclusion and 4 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 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 24 Jun 2016). 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?
Safety - Adverse Event Rate and Severity (time frame: Study Exit (90 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2021; AzTrials last refreshed its copy on 6 Nov 2026.