UNIty-Based MR-Linac Guided AdapTive RadiothErapy for High GraDe Glioma: A Phase 2 Trial

Official Title

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

Summary:

Glioblastoma (GBM) is a high grade glioma (brain tumour) that is treated with surgery or biopsy followed by radiation therapy (RT) given daily over 3 or 6 weeks with or without an oral chemotherapy. Radiation is targeted to the visible residual tumour on magnetic resonance imaging (MRI) images plus a large margin of 15 to 30 mm to account for possible cancer cells outside the visible tumour and for potential growth or shifts in tumour 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 tumour or the patient's anatomy on that given day. This allows for a smaller (5 mm) margin on the visible tumour 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 tumour 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.

Trial Description

Primary Outcome:

  • Imaging-detected tumour recurrence at the edge of the radiation volume ("marginal" failure)
Secondary Outcome:
  • Tumour volume changes during RT
  • Acute radiation toxicity based on RTOG/EORTC Common Toxicity Criteria
  • Quality of life changes based on EORTC QLQ-C30
  • Dexamethasone usage
  • Quality of life based on EORTC QLQ-BN20

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society