Optical Surface Guidance for External Radiotherapy of Head and Neck Cancer

Trial Title: Optical Surface Guidance for External Radiotherapy of Head and Neck Cancer

NCT ID: NCT06627075

Condition: Otorhinolaryngeal Cancer

Conditions: Official terms:
Head and Neck Neoplasms
Otorhinolaryngologic Neoplasms

Conditions: Keywords:
Radiotherapy
Optical surface guidance

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Surface Guided RadioTherapy (SGRT) without mask
Description: Firstly, patients are positioned in a vacuum mattress that moulds their head, neck and shoulders for a reference scan. During the treatment sessions, patients are positioned according to the reference scan, using the surface camera system. Once the observed offsets have been applied, the patient's surface is captured. Treatment can then begin, with continuous monitoring of displacements by the surface camera system. Automatic beam interruption is provided during treatment in the event of motion detection exceeding the standard tolerance threshold (>3 mm). If the use of a thermoformed mask during your treatment prove necessary, for whatever reason, will not result in a halt to the research. Patients receive between 10 and a max of 35 radiotherapy sessions. The follow-up period begins after the last radiotherapy session, and patients are assessed at 4 or 6 weeks and at 3 months by a radiotherapist.
Arm group label: Surface Guided RadioTherapy without face mask

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.

Criteria for eligibility:
Criteria:
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 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: November 2024

Completion date: December 2026

Lead sponsor:
Agency: Center Eugene Marquis
Agency class: Other

Source: Center Eugene Marquis

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06627075