Endometrial CancerNCT01045187
Feasibility Study Using the Xoft System for the Treatment of Endometrial Cancer
A study testing brachytherapy and Xoft Axxent Electronic Brachytherapy System in people with Endometrial Cancer, run by Xoft, Inc. at 6 sites in United States.
Trial summary
Multicenter, non-randomized, feasibility study to evaluate the treatment and assess acute safety of the FDA Cleared Axxent Electronic Brachytherapy System and vaginal applicator for intracavitary vaginal cuff treatment according to the physician's current standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- brachytherapy and Xoft Axxent Electronic Brachytherapy System
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2008to Apr 2010
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Most types of endometrial (uterine) cancer Stage I and Stage II (see exclusion criteria below)
- Post hysterectomy
Who cannot join
- Endometrial (uterine) cancer Stage IA Grade 1
- Scleroderma
- Collagen vascular disease
- Active Lupus
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Cancer Treatment Services Arizona
Casa Grande, Arizona, 85222
Swedish Covenant Hospital
Chicago, Illinois, 60625
Little Company of Mary Hospital
Evergreen Park, Illinois, 60805
Beverly Oncology & Imaging Medical Center, Inc
Montebello, California, 90640
Southwest Oncology Center
Phoenix, Arizona, 85251
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: Feasibility Study Using the Xoft Axxent Electronic Brachytherapy System for the Treatment of Endometrial Cancer
Multicenter, non-randomized, feasibility study to evaluate the treatment and assess acute safety of the FDA Cleared Axxent Electronic Brachytherapy System and vaginal applicator for intracavitary vaginal cuff treatment according to the physician's current standard of care.
- Conditions
- Endometrial Cancer
- Being tested
- brachytherapy, Xoft Axxent Electronic Brachytherapy System
- Keywords
- endometrial cancer, Uterine cancer, electronic brachytherapy, Xoft
- Medical subject headings
- Endometrial Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brachytherapyRadiation
Also called Electronic, Radiation, Vaginal cuff
Electronic brachytherapy dose 21 Gy or 22 Gy in 3-4 fractions prescribed to 5mm depth, or electronic brachytherapy 16-18 Gy if EBRT is administered.
Xoft Axxent Electronic Brachytherapy SystemRadiation
Also called Radiation, therapy, electronic
21-22 Gy in 3-4 fractions to 5mm or 16-18 Gy in 3 fractions prescribed to the surface.
| Study group | Role | What they receive |
|---|---|---|
| endometrial cancer | Other | Patients are treated with electronic brachytherapy for an FDA cleared indication. Receives: Radiation: brachytherapy; Radiation: Xoft Axxent Electronic Brachytherapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System
Measured: through completion of radiation therapy
Secondary outcomes (2)
Assess Acute Safety Outcomes in Patients During and After Vaginal Cuff Brachytherapy Treatment With the Axxent Electronic Brachytherapy System as Incorporated in to the Physician's Current Standard of Practice
Measured: through 3 month post treatment
Assess Occurence Rate of Toxicities
Measured: through 3 month follow up post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startOct 2008
- Primary completionJan 2010
- Study completionApr 2010
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 Endometrial 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xoft, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam Dickler, MD, Principal investigator, Little Company of Mary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045187
- Sponsor's protocol ID
- TPR-0209
- Status last verified
- Jul 2012
- First submitted
- 19 Nov 2009
- Last updated
- 1 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dickler A, Puthawala MY, Thropay JP, Bhatnagar A, Schreiber G. Prospective multi-center trial utilizing electronic brachytherapy for the treatment of endometrial cancer. Radiat Oncol. 2010 Jul 20;5:67. doi: 10.1186/1748-717X-5-67.
PubMed 20646289
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study Using the Xoft Axxent Electronic Brachytherapy System for the Treatment of Endometrial Cancer
- ClinicalTrials.gov ID
- NCT01045187
- Acronym / sponsor ID
- TPR-0209
- Conditions
- Endometrial Cancer
- Keywords
- endometrial cancer, Uterine cancer, electronic brachytherapy, Xoft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Xoft, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 8 Jan 2010 (estimated)
- Results
- Posted 21 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter, non-randomized, feasibility study to evaluate the treatment and assess acute safety of the FDA Cleared Axxent Electronic Brachytherapy System and vaginal applicator for intracavitary vaginal cuff treatment according to the physician's current standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endometrial cancer | Other | Radiation: brachytherapy, Radiation: Xoft Axxent Electronic Brachytherapy SystemPatients are treated with electronic brachytherapy for an FDA cleared indication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Most types of endometrial (uterine) cancer Stage I and Stage II (see exclusion criteria below)
- Post hysterectomy
Key exclusion criteria (4 listed)
- Endometrial (uterine) cancer Stage IA Grade 1
- Scleroderma
- Collagen vascular disease
- Active Lupus
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 |
|---|---|---|
| brachytherapyAlso: Electronic, Radiation, Vaginal cuffElectronic brachytherapy dose 21 Gy or 22 Gy in 3-4 fractions prescribed to 5mm depth, or electronic brachytherapy 16-18 Gy if EBRT is administered. | Radiation | endometrial cancer |
| Xoft Axxent Electronic Brachytherapy SystemAlso: Radiation, therapy, electronic21-22 Gy in 3-4 fractions to 5mm or 16-18 Gy in 3 fractions prescribed to the surface. | Radiation | endometrial cancer |
Primary outcome
Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System
Time frame: through completion of radiation therapy
2 secondary outcomes
Assess Acute Safety Outcomes in Patients During and After Vaginal Cuff Brachytherapy Treatment With the Axxent Electronic Brachytherapy System as Incorporated in to the Physician's Current Standard of Practice
Time frame: through 3 month post treatment
Assess Occurence Rate of Toxicities
Time frame: through 3 month follow up post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20646289Dickler A, Puthawala MY, Thropay JP, Bhatnagar A, Schreiber G. Prospective multi-center trial utilizing electronic brachytherapy for the treatment of endometrial cancer. Radiat Oncol. 2010 Jul 20;5:67. doi: 10.1186/1748-717X-5-67.
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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.
Adam Dickler, MD principal investigator
Little Company of Mary
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brachytherapy and Xoft Axxent Electronic Brachytherapy System in people with Endometrial Cancer, run by Xoft, Inc. at 6 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 2 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 1 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 21 Feb 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?
Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System (time frame: through completion of radiation therapy). 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 NCT01045187, 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 1 Aug 2012.