Use of Non-invasive 4D Ultrasound Clarity System in Prostate IMRT/RapidArc Therapy
Evaluation of the Use of Non-invasive 4D Ultrasound Clarity System in Real-time Tracking of the Target Volume in Prostate IMRT/RapidArc Therapy
研究概览
地位
条件
详细说明
Primarily, this is a single arm phase I study of prostate motion for prostate cancer to primarily compare prostate motion between different treatment duration for IMRT and VMAT. The radiation therapy is to be delivered using intensity modulated radiotherapy (IMRT) or Volumetric Modulated Arc therapy (VMAT) with the aid of volumetric image guidance to ensure accuracy and real-time 3D ultrasound images as observational record of the prostate motion. All the recruited patients are prescribed and treated with either VMAT or IMRT treatment. In order to simulate the behaviour of prostate motion in an IMRT scenario, the group of VMAT patients will be required to remain in treatment position for an additional 7 minutes depending on techniques used (once a week).
In order to assess the level of acceptance of the treatment position, responses to the same comfort survey for the current treatment position (i.e. using leg immobiliser) by a cohort of 60 patients treated in another IGRT treatment room will be used as the baseline. In addition, RTT satisfaction questionnaire will also be administered to assess the handling of the new immobilizer.
Acute toxicity will be measured at preset intervals using CTCAE version 3.0 and as will International prostate symptom score (IPSS) questionnaire which focuses on urinary symptoms. Symptoms or toxicities reported from this study is relevant for patients treated with IMRT or VMAT with full bladder protocol.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Singapore、新加坡、169610
- National Cancer Centre
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patient must be able to provide study-specific informed consent prior to study entry.
Exclusion Criteria:
- Patient who cannot abide to the departmental hydration protocol
- Prostatectomy cases
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatment involved in this protocol requires contact of ultrasound probe to the perineum area.
- Patient enrolled in other clinical trials
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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The extent of intra-fraction prostate motion using an ultrasound system during IMRT and during RapidArc therapy
大体时间:2 years
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2 years
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
The 3D ultrasound capability of the Clarity® system (from Elekta AB Stockholm, Sweden) in providing real-time information of the prostate movement during the treatment delivery
大体时间:2 years
|
2 years
|
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The efficacy of full bladder protocol for patient undergoing prostate radiotherapy
大体时间:2 years
|
2 years
|
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The rate of acute GI and GU side effects within 3 months (<90 days) after radical radiotherapy
大体时间:2 years
|
2 years
|
|
Patient comfort, compliance and tolerance of two setup techniques
大体时间:2 years
|
2 years
|
合作者和调查者
调查人员
- 首席研究员:Jeffrey Kit Long Tuan, Dr、National Cancer Centre, Singapore
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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