Head and Neck NeoplasmsPhase 2/3NCT00363441
A Study of Conventional 3D Radiation vs. Intensity-Modulated Radiation in Squamous Cell Cancer of the Head and Neck
A Phase 2/3 study testing Intensity Modulated Radiotherapy in people with Head and Neck Neoplasms and Squamous Cell Cancer, run by Alberta Health services.
Trial summary
This is a randomized study of conventional 3d radiation versus intensity-modulated radiation in squamous cell cancer of the head and neck. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Squamous Cell Cancer
- What is being tested?
- Intensity Modulated Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 2/3
- 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
- Adult, Older adult
Who may be able to join
- histologically proven squamous cell carcinoma of the head and neck or squamous cell cancer to the neck from an unknown head and neck primary site, stage I-IV disease which is M0, age greater than 18 years, KPS greater than 70, signed study-specific consent
Who cannot join
- M1; bilateral N3 disease; primary greater than 10cm; salivary gland disease; life expectancy less than 2 years; prior radiotherapy to the head and neck; no signed study-specific consent form
About this study
Official title: A Randomized Phase II Study of Conventional 3D Radiation (3DCRT) Versus Intensity-Modulated Radiation (IMRT) in Squamous Cell Cancer of the Head and Neck (SCCHN): Pilot Feasibility Study
This is a randomized study of conventional 3d radiation versus intensity-modulated radiation in squamous cell cancer of the head and neck.
- Conditions
- Head and Neck Neoplasms, Squamous Cell Cancer
- Being tested
- Intensity Modulated Radiotherapy
- Keywords
- head and neck neoplasms, squamous cell cancer, intensity modulated radiotherapy
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity Modulated RadiotherapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and severity of side effects according to Radiation Therapy Oncology Group
scales and CTCAE version 3.0 for acute and chronic radiation toxicities, local control rates
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alberta Health services
- Sponsor type
- University, hospital or other
- Investigators
- Harold P Lau, MD, Principal investigator, Tom Baker Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363441
- Sponsor's protocol ID
- 20313
- Status last verified
- Jan 2011
- First submitted
- 9 Aug 2006
- Last updated
- 19 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Conventional 3D Radiation (3DCRT) Versus Intensity-Modulated Radiation (IMRT) in Squamous Cell Cancer of the Head and Neck (SCCHN): Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT00363441
- Acronym / sponsor ID
- 20313
- Conditions
- Head and Neck Neoplasms, Squamous Cell Cancer
- Keywords
- head and neck neoplasms, squamous cell cancer, intensity modulated radiotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alberta Health servicesUniversity, hospital or other
- First posted
- 15 Aug 2006 (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 is a randomized study of conventional 3d radiation versus intensity-modulated radiation in squamous cell cancer of the head and neck.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- histologically proven squamous cell carcinoma of the head and neck or squamous cell cancer to the neck from an unknown head and neck primary site, stage I-IV disease which is M0, age greater than 18 years, KPS greater than 70, signed study-specific consent
Key exclusion criteria (1 listed)
- M1; bilateral N3 disease; primary greater than 10cm; salivary gland disease; life expectancy less than 2 years; prior radiotherapy to the head and neck; no signed study-specific consent form
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 |
|---|---|---|
| Intensity Modulated Radiotherapy | Procedure or surgery | – |
Primary outcome
Prevalence and severity of side effects according to Radiation Therapy Oncology Group
scales and CTCAE version 3.0 for acute and chronic radiation toxicities, local control rates
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
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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.
Harold P Lau, MD principal investigator
Tom Baker Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intensity Modulated Radiotherapy in people with Head and Neck Neoplasms and Squamous Cell Cancer, run by Alberta Health services.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Prevalence and severity of side effects according to Radiation Therapy Oncology Group. 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 19 Jan 2012.