Head & Neck CancerRISE RNCT07887048
Radiotherapy In a Sitting Position for Enhanced Reproducibility
A study testing Simulation of radiotherapy session in sitting position in people with Head & Neck Cancer, run by Centre Leon Berard.
Trial summary
Qualitative, longitudinal and single-center study To explore the reproductibility and the acceptability of the sitting position for head and neck cancer patients through their experience of sitting and supine positions in the context of radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head & Neck Cancer
- What is being tested?
- Simulation of radiotherapy session in sitting position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2026to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 1. Patient age ≥ 18 years; 2. Head and/or neck cancer patient treated with radiotherapy; 3.Covered by a medical insurance; 4.Signed and dated informed consent document
Who cannot join
- 1. Pregnant women or lactating mother; 2. Patient under guardianship or curatorship; 3. Patient who does not understand or read French; 4. Patient who cannot stand, seat or walk.
About this study
Official title: Repositioning and Immobilisation Assessment for Head and Neck Treatment Localisation in Sitting Position
Qualitative, longitudinal and single-center study To explore the reproductibility and the acceptability of the sitting position for head and neck cancer patients through their experience of sitting and supine positions in the context of radiation therapy.
Read the detailed description
Patients will receive their radiation therapy and undergo a dosimetric CT scan as part of standard care.
During their first week of treatment, an initial positioning in the sitting position will be performed. The time required for positioning and repositioning in both the sitting and supine positions will be recorded, as well as the acquisition of the optical reference image.
The second, third, and fourth positioning sessions in the sitting position will take place during the patient's first two weeks of treatment. The setup and take-off times in the supine and sitting positions will be recorded again, and the reproducibility of sitting position will be assessed by comparing it to the reference image. During the radiotherapy simulation in the sitting position, the patient will be seated in a chair. The chair will perform 6 clockwise and counterclockwise rotations over a 21-minute period. Every 3 minutes, the patient's position will be compared to the reference image. Abdominal discomfort in the sitting position will be assessed at each setup. Comfort, satisfaction, level of apprehension, and difficulty swallowing will be assessed at the end of the four setups.
To study the acceptability of sitting position among patients, a focus group will be organized. Patients will join a videoconference using a pseudonym and turn off their cameras. They will be asked questions, and their reactions will be recorded.
- Conditions
- Head & Neck Cancer
- Being tested
- Simulation of radiotherapy session in sitting position
- 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.
Simulation of radiotherapy session in sitting positionRadiation
Simulation of dosimetry and radiotherapy session in sitting position. Radiation therapy will be perform in supine position and as per standard practices.
| Study group | Role | What they receive |
|---|---|---|
| Standard radiation therapy in supine position and simulation in sitting position | Experimental | Not described Receives: Radiation: Simulation of radiotherapy session in sitting position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with setups performed in sitting position for which all interfraction shifts are below 3 mm in all 3 directions and 3 anatomical subregions
Measured: From enrollment to the end of follow up at 8 months
Secondary outcomes (13)
Proportion of patients with all the measurements below 3 mm in each anatomical subregion
Measured: From enrollment to the end of follow up at 8 months
Variability of the inter fraction motion (quantitative values) measured at each setup
Measured: From enrollment to the end of follow up at 8 months
Variability of the intra fraction motion from optical images during the first 2 weeks for the chin, neck and shoulders over a 21-min period
Measured: From enrollment to the end of follow up at 8 months
Likert scale about satisfaction and comfort in both positions.
Measured: From enrollment to the end of follow up at 8 months
Interruption is defined by the number of times where the patient will request to remove the thermoplastic mask during the beam delivery or the treatment simulation.
Measured: From enrollment to the end of follow up at 8 months
Difference in motion illness symptoms measured before and after upright test based on the motion illiness symptoms classification
Measured: From enrollment to the end of follow up at 8 months
Difference between the result of the distress thermometer in supine and in sitting position
Measured: From enrollment to the end of follow up at 8 months
Rate of patients with dysphagia based on the PRO-CTCAE on difficulty swallowing
Measured: From enrollment to the end of follow up at 8 months
Number of patients who accepted to be setup on the chair and tolerate the simulation of the treatment.
Measured: From enrollment to the end of follow up at 8 months
Time between the moment when the patient is ready to setup and before acquisition of reference images. (in minutes)
Measured: From enrollment to the end of follow up at 8 months
Time between the moment when the patient is ready to setup and before images verification (in minutes).
Measured: From enrollment to the end of follow up at 8 months
Time between the moment when RTT is close to the patient and the patient is in standing position (in minutes).
Measured: From enrollment to the end of follow up at 8 months
Number of interruptions in supine and sitting position during the beam delivery or the treatment simulation
Measured: From enrollment to the end of follow up at 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start31 Dec 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head & 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887048
- Sponsor's protocol ID
- ET26-063 (RISE R)
- Acronym
- RISE R
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 21 Oct 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repositioning and Immobilisation Assessment for Head and Neck Treatment Localisation in Sitting Position
- ClinicalTrials.gov ID
- NCT07887048
- Acronym / sponsor ID
- RISE R / ET26-063 (RISE R)
- Conditions
- Head & Neck Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 21 Oct 2026 (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.
Qualitative, longitudinal and single-center study To explore the reproductibility and the acceptability of the sitting position for head and neck cancer patients through their experience of sitting and supine positions in the context of radiation therapy.
Detailed description
Patients will receive their radiation therapy and undergo a dosimetric CT scan as part of standard care.
During their first week of treatment, an initial positioning in the sitting position will be performed. The time required for positioning and repositioning in both the sitting and supine positions will be recorded, as well as the acquisition of the optical reference image.
The second, third, and fourth positioning sessions in the sitting position will take place during the patient's first two weeks of treatment. The setup and take-off times in the supine and sitting positions will be recorded again, and the reproducibility of sitting position will be assessed by comparing it to the reference image. During the radiotherapy simulation in the sitting position, the patient will be seated in a chair. The chair will perform 6 clockwise and counterclockwise rotations over a 21-minute period. Every 3 minutes, the patient's position will be compared to the reference image. Abdominal discomfort in the sitting position will be assessed at each setup. Comfort, satisfaction, level of apprehension, and difficulty swallowing will be assessed at the end of the four setups.
To study the acceptability of sitting position among patients, a focus group will be organized. Patients will join a videoconference using a pseudonym and turn off their cameras. They will be asked questions, and their reactions will be recorded.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard radiation therapy in supine position and simulation in sitting position | Experimental | Radiation: Simulation of radiotherapy session in sitting position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patient age ≥ 18 years; 2. Head and/or neck cancer patient treated with radiotherapy; 3.Covered by a medical insurance; 4.Signed and dated informed consent document
Key exclusion criteria (1 listed)
- 1. Pregnant women or lactating mother; 2. Patient under guardianship or curatorship; 3. Patient who does not understand or read French; 4. Patient who cannot stand, seat or walk.
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 |
|---|---|---|
| Simulation of radiotherapy session in sitting positionSimulation of dosimetry and radiotherapy session in sitting position. Radiation therapy will be perform in supine position and as per standard practices. | Radiation | Standard radiation therapy in supine position and simulation in sitting position |
Primary outcome
Proportion of patients with setups performed in sitting position for which all interfraction shifts are below 3 mm in all 3 directions and 3 anatomical subregions
Time frame: From enrollment to the end of follow up at 8 months
13 secondary outcomes
Proportion of patients with all the measurements below 3 mm in each anatomical subregion
Time frame: From enrollment to the end of follow up at 8 months
Variability of the inter fraction motion (quantitative values) measured at each setup
Time frame: From enrollment to the end of follow up at 8 months
Variability of the intra fraction motion from optical images during the first 2 weeks for the chin, neck and shoulders over a 21-min period
Time frame: From enrollment to the end of follow up at 8 months
Likert scale about satisfaction and comfort in both positions.
Time frame: From enrollment to the end of follow up at 8 months
Interruption is defined by the number of times where the patient will request to remove the thermoplastic mask during the beam delivery or the treatment simulation.
Time frame: From enrollment to the end of follow up at 8 months
Difference in motion illness symptoms measured before and after upright test based on the motion illiness symptoms classification
Time frame: From enrollment to the end of follow up at 8 months
Difference between the result of the distress thermometer in supine and in sitting position
Time frame: From enrollment to the end of follow up at 8 months
Rate of patients with dysphagia based on the PRO-CTCAE on difficulty swallowing
Time frame: From enrollment to the end of follow up at 8 months
Number of patients who accepted to be setup on the chair and tolerate the simulation of the treatment.
Time frame: From enrollment to the end of follow up at 8 months
Time between the moment when the patient is ready to setup and before acquisition of reference images. (in minutes)
Time frame: From enrollment to the end of follow up at 8 months
Time between the moment when the patient is ready to setup and before images verification (in minutes).
Time frame: From enrollment to the end of follow up at 8 months
Time between the moment when RTT is close to the patient and the patient is in standing position (in minutes).
Time frame: From enrollment to the end of follow up at 8 months
Number of interruptions in supine and sitting position during the beam delivery or the treatment simulation
Time frame: From enrollment to the end of follow up at 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
Related trials for Head & Neck Cancer
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation of radiotherapy session in sitting position in people with Head & Neck Cancer, run by Centre Leon Berard.
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: opening soon, as of the sponsor's last update on 21 Oct 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of patients with setups performed in sitting position for which all interfraction shifts are below 3 mm in all 3 directions and 3 anatomical subregions (time frame: From enrollment to the end of follow up at 8 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 21 Oct 2026.