Otorhinolaryngeal CancerSUGARNCT06627075
Optical Surface Guidance for External Radiotherapy of Head and Neck Cancer
A study testing Surface Guided RadioTherapy (SGRT) without mask in people with Otorhinolaryngeal Cancer, run by Center Eugene Marquis at 1 site in France.
Trial summary
The goal of this clinical trial is to test the use of surface repositioning alone, without a restraint mask, during radiotherapy sessions for patients with head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Otorhinolaryngeal Cancer
- What is being tested?
- Surface Guided RadioTherapy (SGRT) without mask
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2024to 29 Jul 2026
- 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 over 18 years of age
- Patients undergoing palliative or curative treatment for oro-rhino-laryngeal cancer
- Patients with an indication for radiotherapy treatment, with or without complementary treatment (chemotherapy, immunotherapy), with a number of sessions between 10 and 35
- Patients who have dated and signed an informed consent form
Who cannot join
- Patients with uncontrollable movements
- Patients under psychiatric care
- Patients who do not understand or read French
- Patients participating in an interventional study testing another medical intervention
- Patients under guardianship, curatorship, safeguard of justice or deprived of liberty
- Pregnant or breast-feeding women
- Patients without social security coverage
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Lutte contre le Cancer Eugène Marquis
Rennes, Brittany Region, 35042
About this study
Official title: Feasibility of Surface Optical Guidance to Replace the Restraint Mask for External Radiotherapy of Head and Neck Cancer
The goal of this clinical trial is to test the use of surface repositioning alone, without a restraint mask, during radiotherapy sessions for patients with head and neck cancer.
Read the detailed description
In radiotherapy treatments for head and neck cancer, the use of a mask is recommended for patient immobilization. The mask completely covers the head and shoulders, ensuring reproducible positioning at every session. However, using a mask can be oppressive and anxiety-provoking for patients.
At the same time, technological developments have led us to use optical surface camera systems to position and monitor patients in the treatment room. In this way, if a movement exceeding the threshold is detected during a session, the treatment is automatically interrupted.
However, despite the use of the mask, movements are still possible underneath, and are not detected by the surface cameras.
The study's hypothesis is that the use of surface repositioning alone could guarantee reproducible treatment, as in combination with a thermoformed mask. In addition, eliminating the mask would mean greater comfort and improved quality of life for patients.
- Conditions
- Otorhinolaryngeal Cancer
- Being tested
- Surface Guided RadioTherapy (SGRT) without mask
- Keywords
- Radiotherapy, Optical surface guidance
- Medical subject headings
- Otorhinolaryngologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface Guided RadioTherapy (SGRT) without maskProcedure or surgery
Firstly, patients are positioned in a vacuum mattress that moulds their head, neck and shoulders for a reference scan.
During the treatment sessions, patients are positioned according to the reference scan, using the surface camera system.
Once the observed offsets have been applied, the patient's surface is captured. Treatment can then begin, with continuous monitoring of displacements by the surface camera system. Automatic beam interruption is provided during treatment in the event of motion detection exceeding the standard tolerance threshold (>3 mm).
If the use of a thermoformed mask during your treatment prove necessary, for whatever reason, will not result in a halt to the research.
Patients receive between 10 and a max of 35 radiotherapy sessions. The follow-up period begins after the last radiotherapy session, and patients are assessed at 4 or 6 weeks and at 3 months by a radiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Surface Guided RadioTherapy without face mask | Experimental | Radiotherapy sessions will be carried out using the surface camera system, replacing the restraint mask.
Self-assessment questionnaires will also be completed by healthcare professionals concerning the level of difficulty encountered during each SGRT session without mask.
Skin side effects are recorded by the radiotherapist during weekly follow-up consultations.
At the end of treatment, patients complete a patient experience questionnaire. Receives: Procedure: Surface Guided RadioTherapy (SGRT) without mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement patient displacement during surface-guided radiotherapy sessions
Average length of linear translation vector during session (measured by surface cameras) over all sessions performed
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start12 Dec 2024
- Primary completion16 Apr 2026
- Study completion29 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otorhinolaryngeal 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center Eugene Marquis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Coralie Geffroy, Principal investigator, Centre de Lutte contre le Cancer Eugène Marquis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627075
- Sponsor's protocol ID
- 2023-4-74-003
- Other IDs
- 2023-A02324-41
- Acronym
- SUGAR
- Status last verified
- Aug 2026
- First submitted
- 25 Sep 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Surface Optical Guidance to Replace the Restraint Mask for External Radiotherapy of Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT06627075
- Acronym / sponsor ID
- SUGAR / 2023-4-74-003
- Conditions
- Otorhinolaryngeal Cancer
- Keywords
- Radiotherapy, Optical surface guidance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Center Eugene MarquisUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 29 Jul 2026 (actual)
- First posted
- 4 Oct 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.
The goal of this clinical trial is to test the use of surface repositioning alone, without a restraint mask, during radiotherapy sessions for patients with head and neck cancer.
Detailed description
In radiotherapy treatments for head and neck cancer, the use of a mask is recommended for patient immobilization. The mask completely covers the head and shoulders, ensuring reproducible positioning at every session. However, using a mask can be oppressive and anxiety-provoking for patients.
At the same time, technological developments have led us to use optical surface camera systems to position and monitor patients in the treatment room. In this way, if a movement exceeding the threshold is detected during a session, the treatment is automatically interrupted.
However, despite the use of the mask, movements are still possible underneath, and are not detected by the surface cameras.
The study's hypothesis is that the use of surface repositioning alone could guarantee reproducible treatment, as in combination with a thermoformed mask. In addition, eliminating the mask would mean greater comfort and improved quality of life for patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surface Guided RadioTherapy without face mask | Experimental | Procedure: Surface Guided RadioTherapy (SGRT) without maskRadiotherapy sessions will be carried out using the surface camera system, replacing the restraint mask. Self-assessment questionnaires will also be completed by healthcare professionals concerning the level of difficulty encountered during each SGRT session without mask. Skin side effects are recorded by the radiotherapist during weekly follow-up consultations. At the end of treatment, patients complete a patient experience questionnaire. |
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 over 18 years of age
- Patients undergoing palliative or curative treatment for oro-rhino-laryngeal cancer
- Patients with an indication for radiotherapy treatment, with or without complementary treatment (chemotherapy, immunotherapy), with a number of sessions between 10 and 35
- Patients who have dated and signed an informed consent form
Key exclusion criteria (7 listed)
- Patients with uncontrollable movements
- Patients under psychiatric care
- Patients who do not understand or read French
- Patients participating in an interventional study testing another medical intervention
- Patients under guardianship, curatorship, safeguard of justice or deprived of liberty
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 |
|---|---|---|
| Surface Guided RadioTherapy (SGRT) without maskFirstly, patients are positioned in a vacuum mattress that moulds their head, neck and shoulders for a reference scan. During the treatment sessions, patients are positioned according to the reference scan, using the surface camera system. Once the observed offsets have been applied, the patient's surface is captured. Treatment can then begin, with continuous monitoring of displacements by the surface camera system. Automatic beam interruption is provided during treatment in the event of motion detection exceeding the standard tolerance threshold (>3 mm). If the use of a thermoformed mask during your treatment prove necessary, for whatever reason, will not result in a halt to the research. Patients receive between 10 and a max of 35 radiotherapy sessions. The follow-up period begins after the last radiotherapy session, and patients are assessed at 4 or 6 weeks and at 3 months by a radiotherapist. | Procedure or surgery | Surface Guided RadioTherapy without face mask |
Primary outcome
Measurement patient displacement during surface-guided radiotherapy sessions
Time frame: Through study completion, an average of 1 year
Average length of linear translation vector during session (measured by surface cameras) over all sessions performed
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 13 Aug 2026.
Related trials for Otorhinolaryngeal Cancer
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.
Coralie Geffroy principal investigator
Centre de Lutte contre le Cancer Eugène Marquis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surface Guided RadioTherapy (SGRT) without mask in people with Otorhinolaryngeal Cancer, run by Center Eugene Marquis at 1 site in France.
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 7 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 13 Aug 2026. 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 France. 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 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?
Measurement patient displacement during surface-guided radiotherapy sessions (time frame: Through study completion, an average of 1 year). 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 13 Aug 2026.