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NCT06327139Recruiting

Optimising Patient Experience in Head and Neck Radiotherapy

A Phase 3 Study Optimising Patient Experience in Head and Neck Radiotherapy
Irish Research Radiation Oncology GroupPhase 3ClinicalTrials.govdeviceDevice trial
Study focus
Disease/Condition
Head and Neck Cancer
Drug/Device/Intervention
Conventional 5 point closed face immobilisation mask.
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Irish Research Radiation Oncology Group
Location
Dublin, Ireland
Timeline & enrollment
Phase
Phase 3
Start date
Jan 02, 2024
End date
Jul 01, 2025
Enrollment
201 participants
Primary outcome

The setup accuracy of each immobilization device will be measured based on the magnitude of the translational corrections measured in millimeters prior to delivery of each radiation therapy fraction.

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.

ICD-10 classifications
Malignant neoplasm of other and ill-defined sites: Head, face and neckMalignant neoplasm: Skin of scalp and neckMalignant neoplasm: Connective and soft tissue of head, face and neckCarcinoma in situ: Skin of scalp and neckSecondary and unspecified malignant neoplasm: Lymph nodes of head, face and neck
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06327139
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06327139 through Pure Global AI's free database. This Phase 3 trial is sponsored by Irish Research Radiation Oncology Group and is currently Recruiting. The study focuses on Head and Neck Cancer. Target enrollment is 201 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.