Proton versus Photon Radiotherapy In Adults with primary brain tumors Evaluating functional survival A Phase 3 Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Primary endpoint
研究概览
简要总结
This study will be done in adults with brain tumors having good life expectancy requiring treatment with radiotherapy. The current practice for brain radiotherapy involves an advanced technique of radiation using X rays (photon radiotherapy). Another newer technology for delivering radiation is available called proton beam therapy, which allows to reduce the lower dose of radiation to the parts pf brain surrounding the tumor. After treatment with photon radiotherapy certain late effects of radiation like memory decline, hormonal deficits, hearing loss, worsening of neurological function can occur in some patients. From evaluation of dose profiling, proton beam therapy has potential to reduce the possibility of side effects by reducing dose to critical organs. However, there is no clinical data to demonstrate whetherthe theoretical dose reduction translates to a clinically meaningful benefit. In the proposed study, 156 patients will be randomly allocated to either proton or photon radiotherapy in 1: 1 ratio. The primary objective of the study is to explore whether proton therapy improves functional survival which is life expectancy without recurrence, death or complications from radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Primary brain tumors
- •Age at irradiation 18 to 70 years
- •Karnofsky Performance Status more than 60
- •Diagnosis histopathological radiological of primary brain tumor with an expected survival of above 5 years
- •Planned for focal cranial radiotherapy
- •Informed consent taken.
排除标准
- •Reirradiation
- •Palliative radiotherapy
- •Multifocal or multicentric disease
- •Planned for whole brain irradiation or craniospinal irradiation
- •Planned for hypofractionated or stereotactic radiotherapy.
结局指标
主要结局
Primary endpoint
时间窗: 5 years
The 5 year rate of overall survival without functional deterioration functional survival equal to fS will be
时间窗: 5 years
calculated from the date of randomization. An event concerning the primary endpoint will include
时间窗: 5 years
Neurocognitive decline
时间窗: 5 years
CTCAE grade 2 ototoxicity
时间窗: 5 years
New neuroendocrine axis dysfunction or worsening of pre existing dysfunction
时间窗: 5 years
Neurological and functional impairment
时间窗: 5 years
CTCAE gr 3 radionecrosis
时间窗: 5 years
Disease progression
时间窗: 5 years
All cause mortality
时间窗: 5 years
次要结局
- Secondary endpoints:(1. Overall survival & Progression-free survival.)
研究者
Dr ARCHYA DASGUPTA
Tata Memorial Hospital
