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

Not Applicable

• Conditions: Head and Neck Neoplasm

• Registration Number: NCT05011500
• Lead Sponsor: Cancer Research Antwerp

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-29
• Study Start: 2021-06-01
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-17
• Last Update Submitted: 2021-08-17
• Study First Posted: 2021-08-18
• Last Update Posted: 2021-08-18
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.

Trial Locations

Locations (1)

GZA Ziekenhuizen campus Sint-Augustinus; 🇧🇪 Antwerp, Belgium