Optical Surface Guidance for External Radiotherapy of Head and Neck Cancer

Not Applicable

Not yet recruiting

• Conditions: Otorhinolaryngeal Cancer
• Interventions: Procedure: Surface Guided RadioTherapy (SGRT) without mask

• Registration Number: NCT06627075
• Lead Sponsor: Center Eugene Marquis

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-25
• Study First Submitted QC: 2024-10-03
• Last Update Submitted: 2024-10-03
• Study First Posted: 2024-10-04
• Last Update Posted: 2024-10-04
• Study Start: 2024-11
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surface Guided RadioTherapy without face mask	Surface Guided RadioTherapy (SGRT) without mask	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.

Primary Outcome Measures

Name	Time	Method
Measurement patient displacement during surface-guided radiotherapy sessions	Through study completion, an average of 1 year	Average length of linear translation vector during session (measured by surface cameras) over all sessions performed