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临床试验/CTRI/2025/03/082568
CTRI/2025/03/082568招募中3 期

Proton versus Photon Radiotherapy In Adults with primary brain tumors Evaluating functional survival A Phase 3 Randomized Controlled Trial

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2025年4月1日最近更新:

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

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr ARCHYA DASGUPTA

Tata Memorial Hospital

研究点 (1)

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