Head and Neck CancerNCT01011842
Real-Time kV Imaging vs. Real-Time 3D Patient Surface Tracking for Head & Neck Cancer
A study testing Radiotherapy and Align RT in people with Head and Neck Cancer, run by Stanford University at 1 site in United States.
Trial summary
To determine if a new optical system that can track a patient's movement during treatment can be used to measure motion and allow for motion adjustments in order to decrease the amount of healthy tissue that receives radiation without limiting our ability to cure cancers using radiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Radiotherapy and Align RT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with HNC undergoing radiation therapy at Stanford University
- Age >= 18 years old
- Radiation course >= 4 weeks duration
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Factors such as claustrophobia inhibiting use of thermoplastic mask immobilization device.
- Patients who are pregnant or nursing, which preclude them from undergoing active radiation treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Comparison of Intrafraction Motion in Patients With Head and Neck Cancer Using Real-Time kV Imaging vs. Real-Time 3D Patient Surface Tracking
To determine if a new optical system that can track a patient's movement during treatment can be used to measure motion and allow for motion adjustments in order to decrease the amount of healthy tissue that receives radiation without limiting our ability to cure cancers using radiation.
- Conditions
- Head and Neck Cancer
- Being tested
- Radiotherapy, Align RT
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyProcedure or surgery
Also called Radiation therapy, radiation oncology
Standard of care
Align RTProcedure or surgery
Also called Image-Guided Radiation Therapy
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| radiation therapy arm | Experimental | Not described Receives: Procedure: Radiotherapy; Procedure: Align RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
We are measuring how much a patient moves during treatment.
Measured: This information will be available immediately have the patient is treated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2010
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Principal investigator, Quynh-Thu Le, Stanford University
- Investigators
- Quynh-Thu Le, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011842
- Sponsor's protocol ID
- IRB-16791
- Other IDs
- SU-09082009-3800, ENT0028
- Status last verified
- Apr 2019
- First submitted
- 9 Nov 2009
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intrafraction Motion in Patients With Head and Neck Cancer Using Real-Time kV Imaging vs. Real-Time 3D Patient Surface Tracking
- ClinicalTrials.gov ID
- NCT01011842
- Acronym / sponsor ID
- IRB-16791
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- Oct 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if a new optical system that can track a patient's movement during treatment can be used to measure motion and allow for motion adjustments in order to decrease the amount of healthy tissue that receives radiation without limiting our ability to cure cancers using radiation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| radiation therapy arm | Experimental | Procedure: Radiotherapy, Procedure: Align RT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with HNC undergoing radiation therapy at Stanford University
- Age >= 18 years old
- Radiation course >= 4 weeks duration
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (2 listed)
- Factors such as claustrophobia inhibiting use of thermoplastic mask immobilization device.
- Patients who are pregnant or nursing, which preclude them from undergoing active radiation treatment.
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 |
|---|---|---|
| RadiotherapyAlso: Radiation therapy, radiation oncologyStandard of care | Procedure or surgery | radiation therapy arm |
| Align RTAlso: Image-Guided Radiation TherapyStandard of care | Procedure or surgery | radiation therapy arm |
Primary outcome
We are measuring how much a patient moves during treatment.
Time frame: This information will be available immediately have the patient is treated.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- 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.
Quynh-Thu Le principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy and Align RT in people with Head and Neck Cancer, run by Stanford University 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 9 Apr 2019. 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?
The study was stopped early. Results are not available in the source record.
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?
We are measuring how much a patient moves during treatment. (time frame: This information will be available immediately have the patient is treated.). 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 9 Apr 2019.