Optimising Patient Experience in Head and Neck Radiotherapy

Last updated: March 21, 2024
Sponsor: Irish Research Radiation Oncology Group
Overall Status: Active - Recruiting

Phase

3

Condition

Nasopharyngeal Cancer

Head And Neck Cancer

Human Papilloma Virus (Hpv)

Treatment

Conventional 5 point closed face immobilisation mask.

5 point open face immobilization mask

3 point open face immobilization mask

Clinical Study ID

NCT06327139
CTRIAL 23-24
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

Study Design

Total Participants: 201
Treatment Group(s): 3
Primary Treatment: Conventional 5 point closed face immobilisation mask.
Phase: 3
Study Start date:
January 02, 2024
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • St. Luke's Radiation Oncology Network

    Dublin, D06 HH36
    Ireland

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.