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

Cancer Research Antwerp24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Head and Neck Neoplasm

Interventions

Radiotherapy with Closed MaskRADIATION

Radiotherapy for head and neck cancer, using a closed mask (full thermoplastic mask) to restrict patient movement.

Radiotherapy with Open Mask and Surface ScanningRADIATION

Radiotherapy for head and neck cancer, using an open mask to restrict patient movement. Surface Scanning is used to monitor patient movement/positioning.

Radiotherapy with No MaskRADIATION

Radiotherapy for head and neck cancer, without using a mask to restrict patient movement. Surface Scanning is used to monitor patient movement/positioning.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

GZA Ziekenhuizen campus Sint-Augustinus

Antwerp, Belgium

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: Positional Deviation will be assessed from start of treatment period to end of treatment period (up to 7 weeks).

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Central Contacts

Daan Nevens, PhD

CONTACT

0032034433737 Daan.Nevens@gza.be

Data from ClinicalTrials.gov

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