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Optimising Patient Experience in Head and Neck Radiotherapy - Trial NCT06327139

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.

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NCT06327139
Phase 3
Recruiting
Device Trial
device
Trial Details
ClinicalTrials.gov โ€ข NCT06327139
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Optimising Patient Experience in Head and Neck Radiotherapy
A Phase 3 Study Optimising Patient Experience in Head and Neck Radiotherapy

Study Focus

Head and Neck Cancer

Conventional 5 point closed face immobilisation mask.

Interventional

device

Sponsor & Location

Irish Research Radiation Oncology Group

Dublin, Ireland

Timeline & Enrollment

Phase 3

Jan 02, 2024

Jul 01, 2025

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 neck
Malignant neoplasm: Skin of scalp and neck
Malignant neoplasm: Connective and soft tissue of head, face and neck
Carcinoma in situ: Skin of scalp and neck
Secondary and unspecified malignant neoplasm: Lymph nodes of head, face and neck

Data Source

ClinicalTrials.gov

NCT06327139

Device Trial