Optical Surface Guidance for External Radiotherapy of Head and Neck Cancer (SUGAR)

Feasibility of Surface Optical Guidance to Replace the Restraint Mask for External Radiotherapy of Head and Neck Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Otorhinolaryngeal Cancer
• Intervention / Treatment: Procedure: Surface Guided RadioTherapy (SGRT) without mask

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marion Trochet; Phone Number: +33 02 99 25 31 65; Email: m.trochet@rennes.unicancer.fr
• Study Contact Backup: Name: Valérie Jolaine; Phone Number: +33 02 99 25 30 36; Email: v.jolaine@rennes.unicancer.fr

Study Locations

• France
  • Bretagne
    • Rennes, Bretagne, France, 35042
      • Recruiting
      • Centre de lutte contre le cancer Eugène Marquis
      • Contact: Coralie Geffroy; Phone Number: +33 0299253139; Email: c.hulot@rennes.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Center Eugene Marquis
• Investigators: Principal Investigator: Coralie Geffroy, Centre de lutte contre le cancer Eugène Marquis

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2024
• Primary Completion (Estimated): October 12, 2026
• Study Completion (Estimated): January 12, 2027

Study Registration Dates

• First Submitted: September 25, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Radiotherapy; Optical surface guidance
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Otorhinolaryngologic Diseases; Head and Neck Neoplasms; Otorhinolaryngologic Neoplasms
• Other Study ID Numbers: 2023-4-74-003; 2023-A02324-41 (Registry Identifier: ID RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No