Head and Neck Neoplasm
Conditions
Keywords
Radiotherapy, Radiotherapy, Image-Guided
Brief summary
The purpose of this study is to investigate the feasibility of using open masks or no masks in combination with optical surface scanning for radiotherapy in patients with head and neck cancer.
Interventions
RADIATIONRadiotherapy with Closed Mask
Radiotherapy for head and neck cancer, using a closed mask (full thermoplastic mask) to restrict patient movement.
RADIATIONRadiotherapy with Open Mask and Surface Scanning
Radiotherapy for head and neck cancer, using an open mask to restrict patient movement. Surface Scanning is used to monitor patient movement/positioning.
RADIATIONRadiotherapy with No Mask
Radiotherapy for head and neck cancer, without using a mask to restrict patient movement. Surface Scanning is used to monitor patient movement/positioning.
Sponsors
Cancer Research Antwerp
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥ 18 years old * Histologically confirmed head and neck cancer. * Patients treated with radiotherapy (RT) as primary treatment. * An Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0-1 as defined in Appendix 3. * Each subject must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study. * Patients must be willing to comply with treatment plan and other study procedures
Exclusion criteria
* Patients with significantly altered mental status or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study. * Patients who cannot stay still during fraction because of a disorder (e.g. Parkinson's disease)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positional Deviation | Positional Deviation will be assessed from start of treatment period to end of treatment period (up to 7 weeks). | Patient positioning and movement during treatment will be assessed using cone-beam computed tomopgraphy (CBCT). The position of the patient and target volumes measured by CBCT will be compared to computed tomography (CT) scans made during the initial simulation of treatment. CBCT-scans are made right before administering radiation and after radiation has been administered. Translational and rotational deviations will be measured and expressed in millimeters (for translational deviation) and degrees (for rotational deviation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Distress | Patient distress will be assessed from start of treatment period to end of treatment period (up to 7 weeks). | Patient Distress, measured every week using the Subjective Units of Distress Scale (SUDs), a scale of 0-10 where a higher number indicates a worse outcome. |
| Duration of Treatment | Duration of treatment will be assessed from start of treatment period to end of treatment period (up to 7 weeks). | Duration of treatment (in minutes), registered in radiotherapy software. |
| Radiotherapy Technician Satisfaction | Radiotherapy technician satisfaction will be assessed from start of treatment period to end of treatment period (up to 7 weeks). | Personnel satisfaction, questioned weekly using a personnel satisfaction scale from 0 to 10, where a higher number indicates a better outcome. |
| Radiation Dose | Radiation dose will be assessed from start of treatment period to end of treatment period (up to 7 weeks). | In vivo dosimetry will be used to asses the accuracy of treatment. Using PerFRACTION™ in vivo dosimetry. Administered radiation doses will be measured for the target volume and expressed in Gray (Gy). |
Countries
Belgium
Contacts
Primary ContactDaan Nevens, PhD
Outcome results
None listed