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
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2024
CompletedFirst Posted
Study publicly available on registry
October 4, 2024
CompletedStudy Start
First participant enrolled
December 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 12, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 12, 2027
February 13, 2025
September 1, 2024
1.8 years
September 25, 2024
February 11, 2025
Conditions
Keywords
Outcome Measures
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
Through study completion, an average of 1 year
Study Arms (1)
Surface Guided RadioTherapy without face mask
EXPERIMENTALRadiotherapy 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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 may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre de Lutte contre le Cancer Eugène Marquis
Rennes, Brittany Region, 35042, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Coralie Geffroy
Centre de Lutte contre le Cancer Eugène Marquis
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2024
First Posted
October 4, 2024
Study Start
December 12, 2024
Primary Completion (Estimated)
October 12, 2026
Study Completion (Estimated)
January 12, 2027
Last Updated
February 13, 2025
Record last verified: 2024-09