Masks Against Surface-Scanning for Radiation Therapy Immobilisation in Head and Neck Cancer (MASSC Study)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Positional Deviation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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)
Arms & Interventions
Starting with closed mask
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.
Intervention: Radiotherapy with Closed Mask (Radiation)
Starting with closed mask
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.
Intervention: Radiotherapy with Open Mask and Surface Scanning (Radiation)
Starting with closed mask
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.
Intervention: Radiotherapy with No Mask (Radiation)
Starting with open mask
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.
Intervention: Radiotherapy with Closed Mask (Radiation)
Starting with open mask
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.
Intervention: Radiotherapy with Open Mask and Surface Scanning (Radiation)
Starting with open mask
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.
Intervention: Radiotherapy with No Mask (Radiation)
Starting with no mask
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.
Intervention: Radiotherapy with Closed Mask (Radiation)
Starting with no mask
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.
Intervention: Radiotherapy with Open Mask and Surface Scanning (Radiation)
Starting with no mask
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.
Intervention: Radiotherapy with No Mask (Radiation)
Outcomes
Primary Outcomes
Positional Deviation
Time Frame: 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 Outcomes
- Radiation Dose(Radiation dose will be assessed from start of treatment period to end of treatment period (up to 7 weeks).)
- Patient Distress(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 will be assessed from start of treatment period to end of treatment period (up to 7 weeks).)
- Radiotherapy Technician Satisfaction(Radiotherapy technician satisfaction will be assessed from start of treatment period to end of treatment period (up to 7 weeks).)