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临床试验/CTRI/2025/01/079080
CTRI/2025/01/079080尚未招募2 期

Hypofractionated accelerated Radiotherapy versus Conventional Radiotherapy in Glioblastoma Multiforme: A prospective randomised controlled study

Department of Radiotherapy and Radiation Medicine Institute of Medical Sciences BHU1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年1月30日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
52
试验地点
1
主要终点
Loco regional control

研究概览

简要总结

This is a prospective, open label randomised controlled study comparing the safety and efficacy of Hypofractionated accelerated Radiotherapy at 52.5 Grey in 15 fractions with Conventional Radiotherapy at 60 Grey in 30 fractions, both administered with concurrent temozolomide @ 75 mg/m2 once daily throughout radiotherapy and six cycles of adjuvant temozolomide @ 150-200 mg/m2 starting 4 weeks after Radiotherapy, administered once daily for 5 days and each cycle delivered at an interval of 4 weeks in 52 patients of Glioblastoma Multiforme. The study is single institutional which aims to assess loco-regional control as primary outcome and overall survival, progression free survival and Quality of life as secondary oiutcomes.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
10.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Histologically proven patients of Glioblastoma Multiforme
  • Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Patients willing to give written consent for the study.

排除标准

  • Recurrent cases of Glioblastoma Multiforme, previously treated.
  • Patients with any contraindications to Radiotherapy.

结局指标

主要结局

Loco regional control

时间窗: 2 years

次要结局

  • Overall Survival(Progression free survival)

研究者

发起方
Department of Radiotherapy and Radiation Medicine Institute of Medical Sciences BHU
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dipanjan Nandi

Department of Radiotherapy and Radiation Medicine, Institute of Medical Sciences, BHU, Varanasi

研究点 (1)

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