Head and Neck CancerPhase 3OPENNCT06327139
Optimising Patient Experience in Head and Neck Radiotherapy
A Phase 3 study testing Conventional 5 point closed face immobilisation mask., 5 point open face immobilization mask and 3 point open face immobilization mask in people with Head and Neck Cancer, run by Irish Research Radiation Oncology Group at 1 site in Ireland.
Trial summary
This study is a phase III, randomized, single-centre, multiple arm trial examining the set-up accuracy of three different types of immobilization methods for head and neck cancer patients receiving radical radiation therapy. 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?
- Conventional 5 point closed face immobilisation mask., 5 point open face immobilization mask and 3 point open face immobilization mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteIreland
- Study dates
- 2 Jan 2024to Jul 2025
- Phase
- Phase 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All radical H\&N patients receiving 30-35 fractions of Radiotherapy
- Written informed consent obtained prior to any study-specific procedures
- ≥18 years of age
Who cannot join
- 1) Patient who from the outset who would not tolerate or would be unable to proceed with treatment if placed in a closed mask, at the discretion of either the patient or the clinician.
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
St. Luke's Radiation Oncology Network
Dublin, D06 HH36
Roisin O Maolalai, BSc, 0035314065458, Roisin.OMaolalai@slh.ie
Emma Noone, BSc MA, 003534065467, Emma.Noone@slh.ie
About this study
Official title: A Phase 3 Study Optimising Patient Experience in Head and Neck Radiotherapy
This study is a phase III, randomized, single-centre, multiple arm trial examining the set-up accuracy of three different types of immobilization methods for head and neck cancer patients receiving radical radiation therapy. The methods of immobilization under investigation in this study are two types of open faced head and neck masks compared with the convention closed faced head and neck mask. Patients receiving treatment using an open faced mask will have their intra fraction motion monitored through the use of intra fraction surface guided monitoring. The study aims to determine the set-up accuracy of the three types of immobilization through measuring the magnitude of the translational corrections on the daily cone beam computed tomography (CBCT). To be eligible for the study a patient must be planned to receive a minimum of 30 fractions of head and neck radiation therapy.
Patients distress levels associated with each type of immobilization device will be measured using the psychological measure General Health Questionnaire-12 (GHQ-12) which will be collected at the beginning and end of their course of radiation therapy treatment.
Read the detailed description
This study is a phase III, randomized, single-centre, multiple arm trial of immobilization methods for head and neck cancer patients receiving radical radiation therapy.
The two types of immobilization under investigation consist of a faceless three point head and neck mask in conjunction with intra fraction surface guided monitoring and a faceless five point mask in conjunction with intra fraction surface guided monitoring.
The standard of care immobilization consists of a conventional closed face five point mask without the use of intra fraction surface guided monitoring. .
The primary aim of this study is to determine the set-up accuracy of the two types of faceless mask compared with the conventional closed face mask. The set-up accuracy will be measured based on the magnitude of the translational corrections measured prior to delivery of each radiation therapy fraction. This will be measured in millimeters on the daily CBCT.
The secondary aim of this study is to determine the level of distress associated with each type of immobilization device.
A total of 198 evaluable patients will be required for the study. The sample size was calculated based on power calculations to detect clinically significant differences in setup accuracy and patient experience across the three arms.
The enrollment period is expected to be 1 year.
Translational corrections will be measured prior to each fraction of radiation therapy delivered and a minimum of 30 fractions must be delivered in order for a patient to be considered evaluable on trial. The open faced masks will be considered equivalent to the standard of care closed faced mask in terms of set-up accuracy if the difference in translational corrections across the three groups does not indicate a necessity for an increase in the planning target volume for patients planned for radiation therapy treatment using an open faced mask.
Level's of distress will be measured using the psychological measure General Health Questionnaire-12 (GHQ-12). The open faced masks will be considered equivalent to the standard of care closed faced mask the difference in level's of distress between groups does not meet the significance level 0.5.
- Conditions
- Head and Neck Cancer
- Being tested
- Conventional 5 point closed face immobilisation mask., 5 point open face immobilization mask, 3 point open face immobilization mask
- Keywords
- Radiation Therapy, Set-up Accuracy, Faceless Mask, Immobilisation, Quality of Life
- 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.
Conventional 5 point closed face immobilisation mask.Device
The conventional closed face mask is a standard of care immobilization device for head and neck cancer patients which covers and immobilizes the entire anterior portion of the patients head, neck and shoulders using a semi rigid thermoplastic material.
5 point open face immobilization maskDevice
Also called The open face mask is a type of immobilization device for head and neck cancer patients which does not cover the patients face or chest.
The 5 point open face mask is a type of immobilization device for head and neck cancer patients which does not cover the patients face or chest. The device uses a semi rigid thermoplastic material and covers from the superior aspect of the patients head to the level of their clavicle.
3 point open face immobilization maskDevice
The 3 point open face mask is a type of immobilization device for head and neck cancer patients which does not cover the patients face. The device uses a semi rigid thermoplastic material and covers from the superior aspect of the patients head to the below the patients chin. The three point mask does not cover the patients shoulders and does not extend inferiorly to the level of the clavicle.
| Study group | Role | What they receive |
|---|---|---|
| Arm One: Conventional 5 point closed face immobilisation mask. | Active comparator | Participants will be immobilized using the standard of care immobilization for patients receiving radical radiation therapy to the head and neck which is a five point closed face mask. The thermoplastic mask immobilizes the patients head, neck and shoulders fully. Participants randomized to this group will not be monitored using intra fraction surface guided monitoring. Receives: Device: Conventional 5 point closed face immobilisation mask. |
| Arm Two: 5 point open face immobilization mask | Experimental | Participants will be immobilized using the 5 point open face immobilization mask. The thermoplastic mask immobilizes the participants head, neck and shoulders however the mask does not cover the patients anterior portion of the participants face or chest Participants randomized to this group will be monitored using intra fraction surface guided monitoring. Receives: Device: 5 point open face immobilization mask |
| Arm Three: 3 point open face immobilization mask | Experimental | Participants will be immobilized using the 3 point open face immobilization mask. The thermoplastic mask immobilizes the patients head only and does not cover the participants face. Participants randomized to this group will be monitored using intra fraction surface guided monitoring. Receives: Device: 3 point open face immobilization mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
The setup accuracy of each immobilization device will be measured based on the magnitude of the translational corrections measured in millimeters prior to delivery of each radiation therapy fraction.
The vertical, lateral and longitudinal translational corrections are measured in millimeters on the daily pre treatment CBCT. The magnitude of this translational correction will be measured for every fraction of radiation therapy and used as a measurement of the set up accuracy of each type of immobilization device under investigation. The mean (M) and standard deviation (SD) of the corrections of the three arms in the translational direction will be analyzed, using Independent t-test and Mann-Whitney U test
Measured: 21 months
Secondary outcomes (1)
Estimate of distress levels during the first week and during the final week of the participants course of radiation therapy using the psychological measure General Health Questionnaire-12 (GHQ-12).
The mean and standard deviation of the GHQ-12 at first week and final week of treatment will be reported. Scoring will be in line with the published guidelines and will use the GHQ-12 summary score. The scales are from 1(Much less than usual) to 4(More so than usual) with 1 being the worst outcome and from 1(Much less able) to 4 (More so than usual) with 1 being the worst outcome. The proportion of patients who report 'More so than usual' for each domain or measure will be reported. Changes in scores over time for each patient will be calculated by subtracting the results at first week of treatment from the last week of treatment results. The mean and SD of the changes will be reported. A Wilcoxon signed rank test will be used to compare differences from baseline. The number of patients who had a clinically meaningful change in distress levels as identified by the method recommended by the EORTC QoL Group at the time of analysis will also be reported.
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start2 Jan 2024
- Primary completionMay 2025 (estimated)
- Study completionJul 2025 (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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a phase III, randomized, single-centre, multiple arm trial of immobilization methods for head and neck cancer patients receiving radical radiation therapy. A faceless three point head and neck mask in conjunction with intra fraction surface guided monitoring, a faceless five point mask in conjunction with intra fraction surface guided monitoring and a conventional closed face five point mask without the use of intra fraction surface guided monitoring are being investigated in this study. The set-up accuracy will be based on the magnitude of the translational corrections measured prior to delivery of each radiation therapy fraction.
- Masking
- None (open label)
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Irish Research Radiation Oncology Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327139
- Sponsor's protocol ID
- CTRIAL 23-24
- Acronym
- OPEN
- Status last verified
- Mar 2024
- First submitted
- 20 Nov 2023
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study Optimising Patient Experience in Head and Neck Radiotherapy
- ClinicalTrials.gov ID
- NCT06327139
- Acronym / sponsor ID
- OPEN / CTRIAL 23-24
- Conditions
- Head and Neck Cancer
- Keywords
- Radiation Therapy, Set-up Accuracy, Faceless Mask, Immobilisation, Quality of Life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- Irish Research Radiation Oncology GroupResearch network
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 25 Mar 2024 (actual)
- 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 study is a phase III, randomized, single-centre, multiple arm trial examining the set-up accuracy of three different types of immobilization methods for head and neck cancer patients receiving radical radiation therapy. The methods of immobilization under investigation in this study are two types of open faced head and neck masks compared with the convention closed faced head and neck mask. Patients receiving treatment using an open faced mask will have their intra fraction motion monitored through the use of intra fraction surface guided monitoring. The study aims to determine the set-up accuracy of the three types of immobilization through measuring the magnitude of the translational corrections on the daily cone beam computed tomography (CBCT). To be eligible for the study a patient must be planned to receive a minimum of 30 fractions of head and neck radiation therapy.
Patients distress levels associated with each type of immobilization device will be measured using the psychological measure General Health Questionnaire-12 (GHQ-12) which will be collected at the beginning and end of their course of radiation therapy treatment.
Detailed description
This study is a phase III, randomized, single-centre, multiple arm trial of immobilization methods for head and neck cancer patients receiving radical radiation therapy.
The two types of immobilization under investigation consist of a faceless three point head and neck mask in conjunction with intra fraction surface guided monitoring and a faceless five point mask in conjunction with intra fraction surface guided monitoring.
The standard of care immobilization consists of a conventional closed face five point mask without the use of intra fraction surface guided monitoring. .
The primary aim of this study is to determine the set-up accuracy of the two types of faceless mask compared with the conventional closed face mask. The set-up accuracy will be measured based on the magnitude of the translational corrections measured prior to delivery of each radiation therapy fraction. This will be measured in millimeters on the daily CBCT.
The secondary aim of this study is to determine the level of distress associated with each type of immobilization device.
A total of 198 evaluable patients will be required for the study. The sample size was calculated based on power calculations to detect clinically significant differences in setup accuracy and patient experience across the three arms.
The enrollment period is expected to be 1 year.
Translational corrections will be measured prior to each fraction of radiation therapy delivered and a minimum of 30 fractions must be delivered in order for a patient to be considered evaluable on trial. The open faced masks will be considered equivalent to the standard of care closed faced mask in terms of set-up accuracy if the difference in translational corrections across the three groups does not indicate a necessity for an increase in the planning target volume for patients planned for radiation therapy treatment using an open faced mask.
Level's of distress will be measured using the psychological measure General Health Questionnaire-12 (GHQ-12). The open faced masks will be considered equivalent to the standard of care closed faced mask the difference in level's of distress between groups does not meet the significance level 0.5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study is a phase III, randomized, single-centre, multiple arm trial of immobilization methods for head and neck cancer patients receiving radical radiation therapy. A faceless three point head and neck mask in conjunction with intra fraction surface guided monitoring, a faceless five point mask in conjunction with intra fraction surface guided monitoring and a conventional closed face five point mask without the use of intra fraction surface guided monitoring are being investigated in this study. The set-up accuracy will be based on the magnitude of the translational corrections measured prior to delivery of each radiation therapy fraction.
| Arm | Type | Receives |
|---|---|---|
| Arm One: Conventional 5 point closed face immobilisation mask. | Active comparator | Device: Conventional 5 point closed face immobilisation mask.Participants will be immobilized using the standard of care immobilization for patients receiving radical radiation therapy to the head and neck which is a five point closed face mask. The thermoplastic mask immobilizes the patients head, neck and shoulders fully. Participants randomized to this group will not be monitored using intra fraction surface guided monitoring. |
| Arm Two: 5 point open face immobilization mask | Experimental | Device: 5 point open face immobilization maskParticipants will be immobilized using the 5 point open face immobilization mask. The thermoplastic mask immobilizes the participants head, neck and shoulders however the mask does not cover the patients anterior portion of the participants face or chest Participants randomized to this group will be monitored using intra fraction surface guided monitoring. |
| Arm Three: 3 point open face immobilization mask | Experimental | Device: 3 point open face immobilization maskParticipants will be immobilized using the 3 point open face immobilization mask. The thermoplastic mask immobilizes the patients head only and does not cover the participants face. Participants randomized to this group will be monitored using intra fraction surface guided monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All radical H\&N patients receiving 30-35 fractions of Radiotherapy
- Written informed consent obtained prior to any study-specific procedures
- ≥18 years of age
Key exclusion criteria (1 listed)
- 1) Patient who from the outset who would not tolerate or would be unable to proceed with treatment if placed in a closed mask, at the discretion of either the patient or the clinician.
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 |
|---|---|---|
| Conventional 5 point closed face immobilisation mask.The conventional closed face mask is a standard of care immobilization device for head and neck cancer patients which covers and immobilizes the entire anterior portion of the patients head, neck and shoulders using a semi rigid thermoplastic material. | Device | Arm One: Conventional 5 point closed face immobilisation mask. |
| 5 point open face immobilization maskAlso: The open face mask is a type of immobilization device for head and neck cancer patients which does not cover the patients face or chest.The 5 point open face mask is a type of immobilization device for head and neck cancer patients which does not cover the patients face or chest. The device uses a semi rigid thermoplastic material and covers from the superior aspect of the patients head to the level of their clavicle. | Device | Arm Two: 5 point open face immobilization mask |
| 3 point open face immobilization maskThe 3 point open face mask is a type of immobilization device for head and neck cancer patients which does not cover the patients face. The device uses a semi rigid thermoplastic material and covers from the superior aspect of the patients head to the below the patients chin. The three point mask does not cover the patients shoulders and does not extend inferiorly to the level of the clavicle. | Device | Arm Three: 3 point open face immobilization mask |
Primary outcome
The setup accuracy of each immobilization device will be measured based on the magnitude of the translational corrections measured in millimeters prior to delivery of each radiation therapy fraction.
Time frame: 21 months
The vertical, lateral and longitudinal translational corrections are measured in millimeters on the daily pre treatment CBCT. The magnitude of this translational correction will be measured for every fraction of radiation therapy and used as a measurement of the set up accuracy of each type of immobilization device under investigation. The mean (M) and standard deviation (SD) of the corrections of the three arms in the translational direction will be analyzed, using Independent t-test and Mann-Whitney U test
1 secondary outcome
Estimate of distress levels during the first week and during the final week of the participants course of radiation therapy using the psychological measure General Health Questionnaire-12 (GHQ-12).
Time frame: 21 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Conventional 5 point closed face immobilisation mask., 5 point open face immobilization mask and 3 point open face immobilization mask in people with Head and Neck Cancer, run by Irish Research Radiation Oncology Group at 1 site in Ireland.
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 3 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: status not confirmed, as of the sponsor's last update on 25 Mar 2024. 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 Ireland. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roisin O Maolalai (0035314065000, Roisin.OMaolalai@slh.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The setup accuracy of each immobilization device will be measured based on the magnitude of the translational corrections measured in millimeters prior to delivery of each radiation therapy fraction. (time frame: 21 months). 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 25 Mar 2024.