Optical Surface Guidance for External Radiotherapy of Head and Neck Cancer
ConditionOtorhinolaryngeal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCenter Eugene Marquis
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Surface Guided RadioTherapy (SGRT) without mask
Procedure/SurgeryFirstly, 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Surface Guided RadioTherapy without face maskExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Measurement patient displacement during surface-guided radiotherapy sessions
Average length of linear translation vector during session (measured by surface cameras) over all sessions performed
Time frame
Through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov