Optimising Patient Experience in Head and Neck Radiotherapy (OPEN)

Irish Research Radiation Oncology Group

Status and phase: Enrolling; Phase 3

Conditions: Head and Neck Cancer

Treatments: Device: Conventional 5 point closed face immobilisation mask.; Device: 5 point open face immobilization mask; Device: 3 point open face immobilization mask

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06327139

CTRIAL 23-24

Details and patient eligibility

About

This study is a phase III, randomized, single-centre, multiple arm trial examining the set-up accuracy of three different types of immobilization methods for head and neck cancer patients receiving radical radiation therapy. The methods of immobilization under investigation in this study are two types of open faced head and neck masks compared with the convention closed faced head and neck mask. Patients receiving treatment using an open faced mask will have their intra fraction motion monitored through the use of intra fraction surface guided monitoring. The study aims to determine the set-up accuracy of the three types of immobilization through measuring the magnitude of the translational corrections on the daily cone beam computed tomography (CBCT). To be eligible for the study a patient must be planned to receive a minimum of 30 fractions of head and neck radiation therapy.

Patients distress levels associated with each type of immobilization device will be measured using the psychological measure General Health Questionnaire-12 (GHQ-12) which will be collected at the beginning and end of their course of radiation therapy treatment.

Full description

This study is a phase III, randomized, single-centre, multiple arm trial of immobilization methods for head and neck cancer patients receiving radical radiation therapy.

The two types of immobilization under investigation consist of a faceless three point head and neck mask in conjunction with intra fraction surface guided monitoring and a faceless five point mask in conjunction with intra fraction surface guided monitoring.

The standard of care immobilization consists of a conventional closed face five point mask without the use of intra fraction surface guided monitoring. .

The primary aim of this study is to determine the set-up accuracy of the two types of faceless mask compared with the conventional closed face mask. The set-up accuracy will be measured based on the magnitude of the translational corrections measured prior to delivery of each radiation therapy fraction. This will be measured in millimeters on the daily CBCT.

The secondary aim of this study is to determine the level of distress associated with each type of immobilization device.

A total of 198 evaluable patients will be required for the study. The sample size was calculated based on power calculations to detect clinically significant differences in setup accuracy and patient experience across the three arms.

The enrollment period is expected to be 1 year.

Translational corrections will be measured prior to each fraction of radiation therapy delivered and a minimum of 30 fractions must be delivered in order for a patient to be considered evaluable on trial. The open faced masks will be considered equivalent to the standard of care closed faced mask in terms of set-up accuracy if the difference in translational corrections across the three groups does not indicate a necessity for an increase in the planning target volume for patients planned for radiation therapy treatment using an open faced mask.

Level's of distress will be measured using the psychological measure General Health Questionnaire-12 (GHQ-12). The open faced masks will be considered equivalent to the standard of care closed faced mask the difference in level's of distress between groups does not meet the significance level 0.5.

Enrollment: 201 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. All radical H&N patients receiving 30-35 fractions of Radiotherapy
2. Written informed consent obtained prior to any study-specific procedures
3. ≥18 years of age

Exclusion criteria

1. Patient who from the outset who would not tolerate or would be unable to proceed with treatment if placed in a closed mask, at the discretion of either the patient or the clinician.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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201 participants in 3 patient groups

Arm One: Conventional 5 point closed face immobilisation mask.

Active Comparator group

Description:

Participants will be immobilized using the standard of care immobilization for patients receiving radical radiation therapy to the head and neck which is a five point closed face mask. The thermoplastic mask immobilizes the patients head, neck and shoulders fully. Participants randomized to this group will not be monitored using intra fraction surface guided monitoring.

Treatment:

Device: Conventional 5 point closed face immobilisation mask.

Arm Two: 5 point open face immobilization mask

Experimental group

Description:

Participants will be immobilized using the 5 point open face immobilization mask. The thermoplastic mask immobilizes the participants head, neck and shoulders however the mask does not cover the patients anterior portion of the participants face or chest Participants randomized to this group will be monitored using intra fraction surface guided monitoring.

Treatment:

Device: 5 point open face immobilization mask

Arm Three: 3 point open face immobilization mask

Experimental group

Description:

Participants will be immobilized using the 3 point open face immobilization mask. The thermoplastic mask immobilizes the patients head only and does not cover the participants face. Participants randomized to this group will be monitored using intra fraction surface guided monitoring.

Treatment:

Device: 3 point open face immobilization mask