Actively Recruiting
Feasibility of Surface Optical Guidance to Replace the Restraint Mask for External Radiotherapy of Head and Neck Cancer
Led by Center Eugene Marquis · Updated on 2025-02-13
40
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of surface repositioning without a restraint mask during radiotherapy sessions for patients with head and neck cancer. This study explores whether surface optical guidance alone can provide reproducible treatment positioning, potentially improving patient comfort and quality of life by eliminating the traditional mask, which can cause anxiety and discomfort. The study is sponsored by Center Eugene Marquis and focuses on patients undergoing radiotherapy for oro-rhino-laryngeal cancer. Participants will receive between 10 and a maximum of 35 radiotherapy sessions. Patients are positioned using a vacuum mattress to create a reference scan of the head, neck, and shoulders. During treatment, the surface camera system monitors patient positioning and automatically interrupts treatment if movement exceeds 3 millimeters. If necessary, a traditional thermoformed mask may be used without stopping the study. Follow-up assessments occur at 4 or 6 weeks and again at 3 months after treatment completion. Throughout the study, displacement during surface-guided radiotherapy sessions is measured to assess treatment accuracy. Healthcare professionals complete self-assessment questionnaires on session difficulty without the mask, while skin side effects are monitored weekly by radiotherapists. Patients also complete experience questionnaires at the end of treatment. The total participation duration includes treatment and follow-up assessments over approximately one year.
CONDITIONS
Brief Title
Optical Surface Guidance for External Radiotherapy of Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of radiotherapy sessions, between 10 and 35 sessions
Participants receive surface guided radiotherapy without a face mask, positioned using a vacuum mattress and surface camera system. Treatment sessions include continuous monitoring for movement with automatic beam interruption if displacement exceeds tolerance. Participants have between 10 and 35 radiotherapy sessions.
Between 10 and 35 radiotherapy sessions
Duration - Up to 3 months after treatment
After the last radiotherapy session, participants are assessed by a radiotherapist to monitor skin side effects and complete patient experience questionnaires.
Visits at 4 or 6 weeks and at 3 months after treatment
Trial Site Locations
Total: 1 location
1
Centre de Lutte contre le Cancer Eugène Marquis
Rennes, Brittany Region, France, 35042
Actively Recruiting
Research Team
M
Marion Trochet
V
Valérie Jolaine
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
Frequently Asked Questions
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