Squamous Cell Carcinoma of the Oral Cavity and OropharynxBaReToxNCT07413627
A Study Evaluating the Contribution of Non-Coplanar Beam Arrangement in Reducing Toxicity in Radiotherapy for Upper Aerodigestive Tract Cancers
A study testing Coplanar External Beam Radiotherapy and Non-Coplanar External Beam Radiotherapy in people with Squamous Cell Carcinoma of the Oral Cavity and Oropharynx, run by Centre Georges Francois Leclerc at 1 site in France.
Trial summary
Cancers of the upper aerodigestive tract (UADT) are frequently treated with external beam radiotherapy, either alone or in combination with chemotherapy. Despite major advances achieved with intensity-modulated radiotherapy (IMRT/VMAT), irradiation of organs at risk (OARs) remains unavoidable and may lead to acute and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Oral Cavity and Oropharynx
- What is being tested?
- Coplanar External Beam Radiotherapy and Non-Coplanar External Beam Radiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2026to 1 Nov 2029
- 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
- Age ≥ 18 years
- Patient diagnosed with non-operated, non-metastatic squamous cell carcinoma of the oral cavity or oropharynx, histologically confirmed, with p16 status determined by immunohistochemistry, and indicated for curative bilateral radiotherapy, with or without concomitant chemotherapy
- Patient scheduled to receive standard photobiomodulation treatment protocol during radiotherapy
- ECOG performance status ≤ 2
- Presence of xerostomia < 1 according to CTCAE v6.0 at pre-inclusion
- Patient able to provide informed consent and capable of complying with study follow-up, including visits for completion of quality of life questionnaires and salivary tests
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- Patient affiliated with a social security system or equivalent
- Inclusion Criteria (RECOARD 2.0 recommendations) to be confirmed with the information provided by the simulation/plan treatment CT scan :
- Exceedance of a dose constraint for at least one Organ at Risk (OAR) as defined below with a coplanar beam arrangement :
- The average dose delivered to at least one parotid gland must be greater than 26 Grays, and/or => 65% of the oral cavity receives a dose greater than 30 Grays, and/or
- The average dose delivered to at least one submandibular gland must be greater than 32 Grays, and/or
- The average dose delivered to the larynx exceeds 43.5 Grays.
Who cannot join
- Other head and neck locations than the oral cavity and oropharynx, and/or a surgically treated UADT cancer, and/or radiotherapy treatment already started.
- Histologies other than squamous cell carcinoma
- Tumors requiring only unilateral irradiation.
- Non-curative irradiation and/or metastatic patient
- Double tumor localization
- Previous history of head and neck radiotherapy.
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- Inability to comply with study follow-up visits and medical assessments due to geographical, social, or psychological reasons.
- Individuals under legal custody or guardianship (including curatorship).
- Pregnant or breastfeeding women (pregnancy test required at inclusion).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre Georges-François Leclerc
Dijon, 21000
David DT THIBOUW, Doctor, 03 80 73 75 18, DThibouw@cgfl.fr
About this study
Official title: A Randomized Pilot Study Evaluating the Contribution of Non-Coplanar Beam Arrangement in Reducing Toxicity in Radiotherapy for Upper Aerodigestive Tract Cancers
Cancers of the upper aerodigestive tract (UADT) are frequently treated with external beam radiotherapy, either alone or in combination with chemotherapy. Despite major advances achieved with intensity-modulated radiotherapy (IMRT/VMAT), irradiation of organs at risk (OARs) remains unavoidable and may lead to acute and late toxicities such as xerostomia, hyposalivation, swallowing disorders, and impaired quality of life. These toxicities are closely related to the dose delivered to salivary glands and other critical structures, and recommended OAR dose constraints are often exceeded to ensure adequate tumor coverage.
Non-coplanar beam arrangements (NCBA) represent a potential strategy to further reduce radiation dose to OARs while maintaining equivalent target coverage. However, their clinical implementation has been limited due to technical complexity and the risk of collisions between the linear accelerator and the patient. The recent implementation of the opto-numerical solution MapRT® (VisionRT), based on three-dimensional modeling of the patient and the linear accelerator, allows safe and reliable identification of feasible non-coplanar beam trajectories. Retrospective dosimetric analyses conducted at our institution have demonstrated significant dose reductions to several OARs in UADT cancer patients treated with NCBA compared with conventional coplanar beam arrangements, without compromising tumor dose coverage.
Read more
BaReTox is a prospective, open-label, randomized, single-center pilot trial designed to evaluate the clinical impact of non-coplanar beam radiotherapy on treatment-related toxicities and quality of life in patients with non-operated, non-metastatic squamous cell carcinoma of the oral cavity or oropharynx. Adult patients eligible for curative-intent bilateral radiotherapy, with known HPV (p16) status, are randomized to receive either standard coplanar radiotherapy (control arm) or non-coplanar radiotherapy (experimental arm), with or without concomitant chemotherapy. All patients receive a standard photobiomodulation protocol during radiotherapy.
The primary objective is to compare the change in head and neck cancer-specific quality of life between baseline and three months after completion of radiotherapy, assessed using the EORTC QLQ-H\&N35 questionnaire, focusing on swallowing, social eating, and dry mouth domains. Secondary objectives include comparison of acute and late toxicities graded according to CTCAE version 5.0, assessment of salivary function by sialometry, evaluation of global and disease-specific quality of life over time, progression-free survival, feasibility of delivering non-coplanar radiotherapy, dosimetric impact on organs at risk, and evaluation of radiation-induced lymphopenia.
This pilot study aims to provide clinical proof of concept for the benefit of non-coplanar beam radiotherapy in reducing toxicity and improving quality of life in patients with UADT cancers
- Being tested
- Coplanar External Beam Radiotherapy, Non-Coplanar External Beam Radiotherapy
- Keywords
- Head and Neck Squamous Cell Carcinoma, Upper Aerodigestive Tract Cancer, Oral Cavity Cancer, Oropharyngeal Cancer, Radiotherapy, Non-Coplanar Beam Radiotherapy, Xerostomia, Intensity-Modulated Radiotherapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Mouth Neoplasms, Oropharyngeal Neoplasms, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coplanar External Beam RadiotherapyRadiation
Patients receive external beam radiotherapy using a coplanar beam arrangement (standard approach) to treat squamous cell carcinoma of the oral cavity or oropharynx. Treatment is delivered according to routine clinical protocols with curative intent.
Non-Coplanar External Beam RadiotherapyRadiation
Patients receive external beam radiotherapy using a non-coplanar beam arrangement, planned with 3D modeling (MapRT®) to reduce dose to organs at risk while maintaining tumor coverage. Treatment is delivered according to routine clinical protocols with curative intent.
| Study group | Role | What they receive |
|---|---|---|
| Standard Arm - Coplanar Radiotherapy | Active comparator | Patients receive external beam radiotherapy wioth a coplanar beam arrangement, delivered according to standard clinical protocols. Toxicities and quality of life will be assessed during and after treatment. Receives: Radiation: Coplanar External Beam Radiotherapy |
| Experimental Arm - Non-coplanar Radiotherapy | Experimental | Patients receive external beam radiotherapy with a non-coplanar beam arrangement, designed to reduce dose to organs at risk while maintaining tumor coverage. Receives: Radiation: Non-Coplanar External Beam Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life (QOL) after Radiotherapy with Coplanar vs Non-Coplanar Beam Arrangement
This outcome measures the change in quality of life (QOL) from baseline to three months post-radiotherapy using the EORTC QLQ-H\&N35 questionnaire (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Head and Neck Cancer Module). The focus is on swallowing, social eating, and dry mouth symptoms, comparing two different radiotherapy techniques: coplanar external beam radiotherapy (Control Arm) and non-coplanar external beam radiotherapy (Experimental Arm) in patients with squamous cell carcinoma of the oral cavity or oropharynx.
This is a symptom assessment scale. A high score indicates a more unfavourable situation (presence of symptoms). A low score indicates few symptoms.
Measured: From baseline (before radiotherapy) to 3 months after the completion of radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Oral Cavity and OropharynxStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Control Arm: Radiotherapy treatment using coplanar beam arrangement * Experimental Arm: Radiotherapy treatment using non-coplanar beam arrangement
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413627
- Sponsor's protocol ID
- 2025-A02764-45
- Acronym
- BaReTox
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Study Evaluating the Contribution of Non-Coplanar Beam Arrangement in Reducing Toxicity in Radiotherapy for Upper Aerodigestive Tract Cancers
- ClinicalTrials.gov ID
- NCT07413627
- Acronym / sponsor ID
- BaReTox / 2025-A02764-45
- Keywords
- Head and Neck Squamous Cell Carcinoma, Upper Aerodigestive Tract Cancer, Oral Cavity Cancer, Oropharyngeal Cancer, Radiotherapy, Non-Coplanar Beam Radiotherapy, Xerostomia, Intensity-Modulated Radiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 17 Feb 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.
Cancers of the upper aerodigestive tract (UADT) are frequently treated with external beam radiotherapy, either alone or in combination with chemotherapy. Despite major advances achieved with intensity-modulated radiotherapy (IMRT/VMAT), irradiation of organs at risk (OARs) remains unavoidable and may lead to acute and late toxicities such as xerostomia, hyposalivation, swallowing disorders, and impaired quality of life. These toxicities are closely related to the dose delivered to salivary glands and other critical structures, and recommended OAR dose constraints are often exceeded to ensure adequate tumor coverage.
Non-coplanar beam arrangements (NCBA) represent a potential strategy to further reduce radiation dose to OARs while maintaining equivalent target coverage. However, their clinical implementation has been limited due to technical complexity and the risk of collisions between the linear accelerator and the patient. The recent implementation of the opto-numerical solution MapRT® (VisionRT), based on three-dimensional modeling of the patient and the linear accelerator, allows safe and reliable identification of feasible non-coplanar beam trajectories. Retrospective dosimetric analyses conducted at our institution have demonstrated significant dose reductions to several OARs in UADT cancer patients treated with NCBA compared with conventional coplanar beam arrangements, without compromising tumor dose coverage.
BaReTox is a prospective, open-label, randomized, single-center pilot trial designed to evaluate the clinical impact of non-coplanar beam radiotherapy on treatment-related toxicities and quality of life in patients with non-operated, non-metastatic squamous cell carcinoma of the oral cavity or oropharynx. Adult patients eligible for curative-intent bilateral radiotherapy, with known HPV (p16) status, are randomized to receive either standard coplanar radiotherapy (control arm) or non-coplanar radiotherapy (experimental arm), with or without concomitant chemotherapy. All patients receive a standard photobiomodulation protocol during radiotherapy.
The primary objective is to compare the change in head and neck cancer-specific quality of life between baseline and three months after completion of radiotherapy, assessed using the EORTC QLQ-H\&N35 questionnaire, focusing on swallowing, social eating, and dry mouth domains. Secondary objectives include comparison of acute and late toxicities graded according to CTCAE version 5.0, assessment of salivary function by sialometry, evaluation of global and disease-specific quality of life over time, progression-free survival, feasibility of delivering non-coplanar radiotherapy, dosimetric impact on organs at risk, and evaluation of radiation-induced lymphopenia.
This pilot study aims to provide clinical proof of concept for the benefit of non-coplanar beam radiotherapy in reducing toxicity and improving quality of life in patients with UADT cancers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Control Arm: Radiotherapy treatment using coplanar beam arrangement * Experimental Arm: Radiotherapy treatment using non-coplanar beam arrangement
| Arm | Type | Receives |
|---|---|---|
| Standard Arm - Coplanar Radiotherapy | Active comparator | Radiation: Coplanar External Beam RadiotherapyPatients receive external beam radiotherapy wioth a coplanar beam arrangement, delivered according to standard clinical protocols. Toxicities and quality of life will be assessed during and after treatment. |
| Experimental Arm - Non-coplanar Radiotherapy | Experimental | Radiation: Non-Coplanar External Beam RadiotherapyPatients receive external beam radiotherapy with a non-coplanar beam arrangement, designed to reduce dose to organs at risk while maintaining tumor coverage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years
- Patient diagnosed with non-operated, non-metastatic squamous cell carcinoma of the oral cavity or oropharynx, histologically confirmed, with p16 status determined by immunohistochemistry, and indicated for curative bilateral radiotherapy, with or without concomitant chemotherapy
- Patient scheduled to receive standard photobiomodulation treatment protocol during radiotherapy
- ECOG performance status ≤ 2
- Presence of xerostomia < 1 according to CTCAE v6.0 at pre-inclusion
Key exclusion criteria (9 listed)
- Other head and neck locations than the oral cavity and oropharynx, and/or a surgically treated UADT cancer, and/or radiotherapy treatment already started.
- Histologies other than squamous cell carcinoma
- Tumors requiring only unilateral irradiation.
- Non-curative irradiation and/or metastatic patient
- Double tumor localization
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 |
|---|---|---|
| Coplanar External Beam RadiotherapyPatients receive external beam radiotherapy using a coplanar beam arrangement (standard approach) to treat squamous cell carcinoma of the oral cavity or oropharynx. Treatment is delivered according to routine clinical protocols with curative intent. | Radiation | Standard Arm - Coplanar Radiotherapy |
| Non-Coplanar External Beam RadiotherapyPatients receive external beam radiotherapy using a non-coplanar beam arrangement, planned with 3D modeling (MapRT®) to reduce dose to organs at risk while maintaining tumor coverage. Treatment is delivered according to routine clinical protocols with curative intent. | Radiation | Experimental Arm - Non-coplanar Radiotherapy |
Primary outcome
Change in Quality of Life (QOL) after Radiotherapy with Coplanar vs Non-Coplanar Beam Arrangement
Time frame: From baseline (before radiotherapy) to 3 months after the completion of radiotherapy.
This outcome measures the change in quality of life (QOL) from baseline to three months post-radiotherapy using the EORTC QLQ-H\&N35 questionnaire (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Head and Neck Cancer Module). The focus is on swallowing, social eating, and dry mouth symptoms, comparing two different radiotherapy techniques: coplanar external beam radiotherapy (Control Arm) and non-coplanar external beam radiotherapy (Experimental Arm) in patients with squamous cell carcinoma of the oral cavity or oropharynx. This is a symptom assessment scale. A high score indicates a more unfavourable situation (presence of symptoms). A low score indicates few symptoms.
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 18 Feb 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coplanar External Beam Radiotherapy and Non-Coplanar External Beam Radiotherapy in people with Squamous Cell Carcinoma of the Oral Cavity and Oropharynx, run by Centre Georges Francois Leclerc 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 12 inclusion and 9 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 18 Feb 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?
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?
Contact David DT THIBOUW, Doctor (03 45 34 81 07, dthibouw@cgfl.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life (QOL) after Radiotherapy with Coplanar vs Non-Coplanar Beam Arrangement (time frame: From baseline (before radiotherapy) to 3 months after the completion of radiotherapy.). 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 18 Feb 2026; AzTrials last refreshed its copy on 1 Nov 2026.