Economic Evaluation of Image Guided Radiation Therapy For Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 470
- 试验地点
- 1
- 主要终点
- Prostate position under the LINAC is checked by 3D OBI (mainly cone-beam imaging, CBI) performed before the fraction.
研究概览
简要总结
During the 7 to 8 weeks of conformal radiotherapy for prostate carcinoma, the prostate has an intra-pelvic motion which is not detectable by the conventional portal imaging. This prostate motion may lead to a mistargeting, which possibly decreases the local control. On the other hand, the new 3D on board imaging (3D OBI) allows to localize the target but is expensive. The cost/effectiveness ratio is not well established, as well as the frequency of using such imaging during the course of radiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •prostate adenocarcinoma
- •intermediate / high risk group
- •N0 or N -
- •treatment by conformal radiotherapy (including or not IMRT), with or without androgen deprivation
排除标准
- •pelvic irradiation
- •metal objects in the pelvis
研究组 & 干预措施
Standard imaging
干预措施: Standard imaging (Procedure)
Control position by 3DOBI daily
干预措施: Control position by 3DOBI before the fraction (Procedure)
结局指标
主要结局
Prostate position under the LINAC is checked by 3D OBI (mainly cone-beam imaging, CBI) performed before the fraction.
To validate the optimal strategy of IGRT for prostate adenocarcinoma based on 2 and 5 year-disease free survival rates (events= biochemical failure or death).
次要结局
- Rectal and bladder, acute and late toxicities (CTCAE, SOMA-LENT)
- Cost comparison and cost/effectiveness analysis
- Lack of dose in the prostate in case of decreasing the CBI frequency (using the 1rst arm for testing)
- 2 and 5 years clinical relapse free survival rates