Optical Surface Guidance for External Radiotherapy of Head and Neck Cancer

NCT ID: NCT06627075

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-12
• Study Completion Date: 2027-01-12

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.

Conditions

Otorhinolaryngeal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Surface Guided RadioTherapy without face 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.

Group Type: EXPERIMENTAL

Surface Guided RadioTherapy (SGRT) without mask

Intervention Type: PROCEDURE

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.

Interventions

Surface Guided RadioTherapy (SGRT) without mask

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center Eugene Marquis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Coralie Geffroy

Role: PRINCIPAL_INVESTIGATOR

Centre de Lutte contre le Cancer Eugène Marquis

Locations

Centre de Lutte contre le Cancer Eugène Marquis

Rennes, Brittany Region, France

Site Status: RECRUITING

Countries

France

Central Contacts

Marion Trochet

Role: CONTACT

m.trochet@rennes.unicancer.fr

02 99 25 31 65 ext. +33

Valérie Jolaine

Role: CONTACT

v.jolaine@rennes.unicancer.fr

02 99 25 30 36 ext. +33

Facility Contacts

Coralie Geffroy

Role: primary

c.hulot@rennes.unicancer.fr

0299253139 ext. +33

Other Identifiers

2023-A02324-41

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-4-74-003

Identifier Type: -

Identifier Source: org_study_id