A Study Evaluating the Contribution of Non-Coplanar Beam Arrangement in Reducing Toxicity in Radiotherapy for Upper Aerodigestive Tract Cancers

NCT07413627 | Not Yet Recruiting

• 1 other identifier: 2025-A02764-45
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Squamous Cell Carcinoma of the Oral Cavity and Oropharynx

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

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline (before radiotherapy) to 3 months after the completion of radiotherapy.

Study Arms (2)

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.

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.

Radiation: Non-Coplanar External Beam Radiotherapy

Interventions

Coplanar External Beam Radiotherapy RADIATION

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.

Standard Arm - Coplanar Radiotherapy

Non-Coplanar External Beam Radiotherapy RADIATION

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.

Experimental Arm - Non-coplanar Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Patient affiliated with a social security system or equivalent
• \- 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (1)

Centre Georges-François Leclerc

Dijon, 21000, France

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Mouth Neoplasms; Oropharyngeal Neoplasms; Xerostomia

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Salivary Gland Diseases

Central Study Contacts

David DT THIBOUW, Doctor

CONTACT

03 45 34 81 07; dthibouw@cgfl.fr

Emilie ER REDERSTORFF, Project Manager

CONTACT

03 45 34 81 16; erederstorff@cgfl.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Control Arm: Radiotherapy treatment using coplanar beam arrangement * Experimental Arm: Radiotherapy treatment using non-coplanar beam arrangement

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): November 1, 2029
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)