A Phase 3 Study Optimising Patient Experience in Head and Neck Radiotherapy
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All radical H&N patients receiving 30-35 fractions of Radiotherapy
- •Written informed consent obtained prior to any study-specific procedures
- •≥18 years of age
排除标准
- •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.
研究组 & 干预措施
Arm Three: 3 point open face immobilization mask
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.
干预措施: 3 point open face immobilization mask (Device)
Arm One: Conventional 5 point closed face immobilisation mask.
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.
干预措施: Conventional 5 point closed face immobilisation mask. (Device)
Arm Two: 5 point open face immobilization mask
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.
干预措施: 5 point open face immobilization mask (Device)
结局指标
主要结局
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.
时间窗: 21 months
The vertical, lateral and longitudinal translational corrections are measured in millimeters on the daily pre treatment CBCT. The magnitude of this translational correction will be measured for every fraction of radiation therapy and used as a measurement of the set up accuracy of each type of immobilization device under investigation. The mean (M) and standard deviation (SD) of the corrections of the three arms in the translational direction will be analyzed, using Independent t-test and Mann-Whitney U test
次要结局
- Estimate of distress levels during the first week and during the final week of the participants course of radiation therapy using the psychological measure General Health Questionnaire-12 (GHQ-12).(21 months)