Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06327139
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2023-11-20
Brief Title:
Optimising Patient Experience in Head and Neck Radiotherapy
Sponsor:
Irish Research Radiation Oncology Group
Organization:
Irish Research Radiation Oncology Group
Study Overview
Official Title:
A Phase 3 Study Optimising Patient Experience in Head and Neck Radiotherapy
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPEN
Brief 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
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
Detailed 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
Levels 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 levels of distress between groups does not meet the significance level 05
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
Levels 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 levels of distress between groups does not meet the significance level 05
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None