Masks Against Surface-Scanning for Radiation Therapy Immobilisation in Head and Neck Cancer (MASSC)

Study Overview
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Brief Summary
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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.

Official Title
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Masks Against Surface-Scanning for Radiation Therapy Immobilisation in Head and Neck Cancer (MASSC Study)

Conditions
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Head and Neck Neoplasm

Intervention / Treatment
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* Radiation: Radiotherapy with Closed Mask
* Radiation: Radiotherapy with Open Mask and Surface Scanning
* Radiation: Radiotherapy with No Mask


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Starting with closed mask<br>Patient 1-8, receiving radiotherapy for head and neck cancer in this study. Patients will receive 35 fractions of radiotherapy in total. For the first 5 fractions these patients will receive radiotherapy using a closed mask. For the next 5 fractions these patients will receive radiotherapy using an open mask. For the 5 fractions after that these patients will receive radiotherapy using no mask. This schedule repeats for the rest of their treatment. | Radiation: Radiotherapy with Closed Mask<br>* Radiotherapy for head and neck cancer, using a closed mask (full thermoplastic mask) to restrict patient movement.<br>* Other names: Full thermoplastic mask;Radiation: Radiotherapy with Open Mask and Surface Scanning<br>* Radiotherapy for head and neck cancer, using an open mask to restrict patient movement. Surface Scanning is used to monitor patient movement/positioning.<br>Radiation: Radiotherapy with No Mask<br>* Radiotherapy for head and neck cancer, without using a mask to restrict patient movement. Surface Scanning is used to monitor patient movement/positioning.<br>|
| Experimental: Starting with open mask<br>Patient 9-16, receiving radiotherapy for head and neck cancer in this study. Patients will receive 35 fractions of radiotherapy in total. For the first 5 fractions these patients will receive radiotherapy using an open mask. For the next 5 fractions these patients will receive radiotherapy using no mask. For the 5 fractions after that these patients will receive radiotherapy using a closed mask. This schedule repeats for the rest of their treatment. | Radiation: Radiotherapy with Closed Mask<br>* Radiotherapy for head and neck cancer, using a closed mask (full thermoplastic mask) to restrict patient movement.<br>* Other names: Full thermoplastic mask;Radiation: Radiotherapy with Open Mask and Surface Scanning<br>* Radiotherapy for head and neck cancer, using an open mask to restrict patient movement. Surface Scanning is used to monitor patient movement/positioning.<br>Radiation: Radiotherapy with No Mask<br>* Radiotherapy for head and neck cancer, without using a mask to restrict patient movement. Surface Scanning is used to monitor patient movement/positioning.<br>|
| Experimental: Starting with no mask<br>Patient 17-24, receiving radiotherapy for head and neck cancer in this study. Patients will receive 35 fractions of radiotherapy in total. For the first 5 fractions these patients will receive radiotherapy using no mask. For the next 5 fractions these patients will receive radiotherapy using a closed mask. For the 5 fractions after that these patients will receive radiotherapy using an open mask. This schedule repeats for the rest of their treatment. | Radiation: Radiotherapy with Closed Mask<br>* Radiotherapy for head and neck cancer, using a closed mask (full thermoplastic mask) to restrict patient movement.<br>* Other names: Full thermoplastic mask;Radiation: Radiotherapy with Open Mask and Surface Scanning<br>* Radiotherapy for head and neck cancer, using an open mask to restrict patient movement. Surface Scanning is used to monitor patient movement/positioning.<br>Radiation: Radiotherapy with No Mask<br>* Radiotherapy for head and neck cancer, without using a mask to restrict patient movement. Surface Scanning is used to monitor patient movement/positioning.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positional Deviation | 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). | Positional Deviation will be assessed from start of treatment period to end of treatment period (up to 7 weeks). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Distress | 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. | Patient distress will be assessed from start of treatment period to end of treatment period (up to 7 weeks). | 
| Duration of Treatment | Duration of treatment (in minutes), registered in radiotherapy software. | Duration of treatment will be assessed from start of treatment period to end of treatment period (up to 7 weeks). | 
| Radiotherapy Technician Satisfaction | Personnel satisfaction, questioned weekly using a personnel satisfaction scale from 0 to 10, where a higher number indicates a better outcome. | Radiotherapy technician satisfaction will be assessed from start of treatment period to end of treatment period (up to 7 weeks). | 
| Radiation Dose | 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). | Radiation dose will be assessed from start of treatment period to end of treatment period (up to 7 weeks). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy, Radiotherapy, Image-Guided