Head and Neck CarcinomaPhase 1NCT01384890
Feasibility of VMAT and CBCT for Head and Neck Carcinomas
A Phase 1 study testing VMAT with CBCT and VMAT with kV-ray in people with Head and Neck Carcinoma, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
This will be a prospective longitudinal study describing clinical throughput metrics and patient reported quality of life outcome measures for patients undergoing Volumetric modulated arc therapy (VMAT) with and without Cone-beam computed tomography (CBCT) for head and neck carcinoma at the British Columbia Cancer… Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Head and Neck Carcinoma
- What is being tested?
- VMAT with CBCT and VMAT with kV-ray
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to May 2012
- Phase
- Phase 1
- 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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age greater than 18 years
- undergoing radical radiation therapy for head and neck carcinoma at the BC Cancer Agency
Who cannot join
- treatment being offered is not for curative intent
- patient has received previous radiation for head and neck cancer
- patient has systemic lupus erythematosis or scleroderma
- patients has other autoimmune connective tissue disorders
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, V5Z4E6
About this study
Official title: Feasibility of Volumetric Modulated Arc Therapy and Cone-Beam Computed Tomography for Head and Neck Carinomas: Analysis of Clinical Throughput and Patient Reported Outcomes.
This will be a prospective longitudinal study describing clinical throughput metrics and patient reported quality of life outcome measures for patients undergoing Volumetric modulated arc therapy (VMAT) with and without Cone-beam computed tomography (CBCT) for head and neck carcinoma at the British Columbia Cancer Agency.
- VMAT for the treatment of patients with HNC will provide opportunities for image-guided radiotherapy using CBCT online correction to reduce systematic and random error.
- Analysis of patient reported quality of life outcomes during VMAT, with and without CBCT acquisition, will be hypothesis generating.
- Conditions
- Head and Neck Carcinoma
- Being tested
- VMAT with CBCT, VMAT with kV-ray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VMAT with CBCTRadiation
volumetric modulated arc therapy (VMAT) with cone-beam computed tomography (CBCT) position verification
VMAT with kV-rayRadiation
Volumetric modulated arc therapy (VMAT) with kV-ray position verification
| Study group | Role | What they receive |
|---|---|---|
| VMAT with CBCT | Experimental | Volumetric modulated arc therapy (VMAT) with cone-beam computed tomography position (CBCT) verification Receives: Radiation: VMAT with CBCT |
| VMAT with kV-ray | Active comparator | Volumetric modulation arc therapy (VMAT) with kV-ray position verification Receives: Radiation: VMAT with kV-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficiency for volumetric modulated arc therapy (VMAT) delivery
Prospective work-flow metrics describing clinical efficiency for volumetric modulated arc therapy (VMAT) delivery with and without cone-beam computed tomography (CBCT) acquisition at the BCCA, generated from time requirements for treatment verification and delivery. The time spent by the patients at each stage of radiation therapy delivery will be recorded, including; time in radiation bunker, time in immobilization frame, kV or CBCT acquisition and online correction time, and beam on time
Measured: After patient treated
Position verification
Summary description of position verification and online corrections for volumetric modulated arch therapy (VMAT) delivery with and without cone-beam computed tomography (CBCT)
Measured: After patient treated
Secondary outcomes (1)
Quality of life
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Head and Neck Cancer (EORTC QLQ - HN35) (23) (see Appendix V) and State Trait Anxiety Index (STAI)
Measured: No time frame (ongoing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CarcinomaStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonn Wu, British Columbia Cancer Agency
- Investigators
- Jonn Wu, MD, Principal investigator, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384890
- Sponsor's protocol ID
- VMAT, CBCT for H&N ca
- Status last verified
- Feb 2013
- First submitted
- 28 Jun 2011
- Last updated
- 6 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Volumetric Modulated Arc Therapy and Cone-Beam Computed Tomography for Head and Neck Carinomas: Analysis of Clinical Throughput and Patient Reported Outcomes.
- ClinicalTrials.gov ID
- NCT01384890
- Acronym / sponsor ID
- VMAT, CBCT for H&N ca
- Conditions
- Head and Neck Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 29 Jun 2011 (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.
This will be a prospective longitudinal study describing clinical throughput metrics and patient reported quality of life outcome measures for patients undergoing Volumetric modulated arc therapy (VMAT) with and without Cone-beam computed tomography (CBCT) for head and neck carcinoma at the British Columbia Cancer Agency.
- VMAT for the treatment of patients with HNC will provide opportunities for image-guided radiotherapy using CBCT online correction to reduce systematic and random error.
- Analysis of patient reported quality of life outcomes during VMAT, with and without CBCT acquisition, will be hypothesis generating.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VMAT with CBCT | Experimental | Radiation: VMAT with CBCTVolumetric modulated arc therapy (VMAT) with cone-beam computed tomography position (CBCT) verification |
| VMAT with kV-ray | Active comparator | Radiation: VMAT with kV-rayVolumetric modulation arc therapy (VMAT) with kV-ray position verification |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- age greater than 18 years
- undergoing radical radiation therapy for head and neck carcinoma at the BC Cancer Agency
Key exclusion criteria (4 listed)
- treatment being offered is not for curative intent
- patient has received previous radiation for head and neck cancer
- patient has systemic lupus erythematosis or scleroderma
- patients has other autoimmune connective tissue disorders
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 |
|---|---|---|
| VMAT with CBCTvolumetric modulated arc therapy (VMAT) with cone-beam computed tomography (CBCT) position verification | Radiation | VMAT with CBCT |
| VMAT with kV-rayVolumetric modulated arc therapy (VMAT) with kV-ray position verification | Radiation | VMAT with kV-ray |
Primary outcome
Clinical efficiency for volumetric modulated arc therapy (VMAT) delivery
Time frame: After patient treated
Prospective work-flow metrics describing clinical efficiency for volumetric modulated arc therapy (VMAT) delivery with and without cone-beam computed tomography (CBCT) acquisition at the BCCA, generated from time requirements for treatment verification and delivery. The time spent by the patients at each stage of radiation therapy delivery will be recorded, including; time in radiation bunker, time in immobilization frame, kV or CBCT acquisition and online correction time, and beam on time
Position verification
Time frame: After patient treated
Summary description of position verification and online corrections for volumetric modulated arch therapy (VMAT) delivery with and without cone-beam computed tomography (CBCT)
1 secondary outcome
Quality of life
Time frame: No time frame (ongoing)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2013.
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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.
Jonn Wu, MD principal investigator
British Columbia Cancer Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VMAT with CBCT and VMAT with kV-ray in people with Head and Neck Carcinoma, run by British Columbia Cancer Agency at 1 site in Canada.
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 6 Feb 2013. 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical efficiency for volumetric modulated arc therapy (VMAT) delivery (time frame: After patient treated). The study lists 2 primary outcomes in all. 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 6 Feb 2013.