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临床试验/NCT04726397
NCT04726397已完成不适用

UNIty-Based MR-Linac Guided AdapTive RadiothErapy for High GraDe Glioma: a Phase 2 Trial (UNITED Trial)

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2021年3月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
2
主要终点
Imaging-detected tumor recurrence at the edge of the radiation volume ("marginal" failure)

研究概览

简要总结

Glioblastoma (GBM) is a high grade glioma (brain tumor) that is treated with surgery or biopsy followed by radiotherapy (RT) given daily over 3 or 6 weeks with or without an oral chemotherapy. Radiation is targeted to the visible residual tumor on magnetic resonance imaging (MRI) images plus a large margin of 15 to 30 mm to account for possible cancer cells outside the visible tumor and for potential growth or shifts in tumor position throughout the prolonged RT course. Standard RT uses MRI to create a reference plan (with large margins) and treats that same volume every day. This exposes a large amount of healthy brain tissue to radiation leading to toxicity and reduced quality of life.

A new technology, the MR-Linac, combines an MRI scanner and a Linac (radiation delivery machine) into one unit. This allows for "adaptive" RT by obtaining an updated MRI scan each day just prior to treatment, adapting the RT plan to take into account any changes in the tumor or the patient's anatomy on that given day. This allows for a smaller (5 mm) margin on the visible tumor as its position can be tracked daily. The goal of this study is to use adaptive RT with small margins to demonstrate that the local control of the visible tumor is not compromised compared to the large volumes used with standard non-adaptive RT, while determining whether smaller margins lead to decreased radiation toxicity and therefore improved quality of life by minimizing radiation exposure.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 years and older
  • Histopathologically confirmed malignant glioma of the brain, Grade 4 (GBM)
  • Eligible for RT in 15 or 30 fractions with or without chemotherapy (temozolamide)
  • Expected survival greater than 12 weeks
  • WHO performance status less than or equal to 2
  • Able to converse and answer questionnaires in English language
  • Has a maximum final planning volume less than 150 cm3

排除标准

  • Contraindications to MRI examination as per standard MRI screening policy
  • Contraindication to Gadolinium-based contrast media
  • Unable to lie flat in a supine position for 30 minutes
  • Poor baseline kidney function with an eGFR < 60 mL/min
  • Unable to tolerate immobilization in a head thermoplastic mask
  • Patients >140 kg and/or a circumference >60cm
  • Previous cranial irradiation
  • Infratentorial tumour extent, multifocal of leptomeningeal disease
  • Unable to give informed consent

结局指标

主要结局

Imaging-detected tumor recurrence at the edge of the radiation volume ("marginal" failure)

时间窗: Within 1 year from end of radiation

The presence of tumor on contrast-enhanced MRI between 1-2 cm from the edge of the treated radiation volume (commonly known as a marginal failure) within 1 year from radiation.

次要结局

  • Acute radiation toxicity based on RTOG/EORTC Common Toxicity Criteria(6 weeks)
  • Tumor volume changes during RT(6 weeks)
  • Quality of life changes based on EORTC QLQ-C30(1 year)
  • Quality of life based on EORTC QLQ-BN20(1 year)
  • Dexamethasone usage(10 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jay Detsky

Radiation Oncologist

Sunnybrook Health Sciences Centre

研究点 (2)

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