Otorhinolaryngeal Cancer
Conditions
Keywords
Radiotherapy, Optical surface guidance
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.
Interventions
PROCEDURESurface 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.
Sponsors
Center Eugene Marquis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement patient displacement during surface-guided radiotherapy sessions | Through study completion, an average of 1 year | Average length of linear translation vector during session (measured by surface cameras) over all sessions performed |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORCoralie Geffroy
Centre de Lutte contre le Cancer Eugène Marquis
Outcome results
None listed