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

February 16, 2026 updated by: Centre Georges Francois Leclerc

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.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: David DT THIBOUW, Doctor
  • Phone Number: 03 45 34 81 07
  • Email: dthibouw@cgfl.fr

Study Contact Backup

  • Name: Emilie ER REDERSTORFF, Project Manager
  • Phone Number: 03 45 34 81 16
  • Email: erederstorff@cgfl.fr

Study Locations

  • France
      • Dijon, France, 21000
        • Centre Georges-Francois Leclerc
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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).
  • Pregnant or breastfeeding women (pregnancy test required at inclusion).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Arm - Coplanar Radiotherapy
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
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.
Experimental: Experimental Arm - Non-coplanar Radiotherapy
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline (before radiotherapy) to 3 months after the completion of radiotherapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Georges Francois Leclerc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

February 28, 2028

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-A02764-45

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Squamous Cell Carcinoma of the Oral Cavity and Oropharynx

Clinical Trials on Coplanar External Beam Radiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe