Skip to main content
OpenTrials
Completed

NCT Number: NCT04726397

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glioblastoma Multiforme Astrocytoma Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Reduced margin adaptive radiotherapy

Radiation

Reduced (5 mm) clinical target volume margin with weekly contrast-enhanced adaptive radiation on the MR-Linac treatment machine

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Tumor volume changes during RT

    Time frame: 6 weeks

    Change in gross tumor volume (%) from start to end of RT

  2. Acute radiation toxicity based on RTOG/EORTC Common Toxicity Criteria

    Time frame: 6 weeks

    Grades 1-4 toxicity during RT in the following categories: skin, CNS, eye, ear, and hematological

  3. Quality of life changes based on EORTC QLQ-C30

    Time frame: 1 year

    Changes in quality of life during and after RT based on accepted EORTC cancer quality of life instruments administered each week on RT, 1 month post RT, and every 3 months subsequently

  4. Dexamethasone usage

    Time frame: 10 weeks

    Amount of dexamethasone required during RT

  5. Quality of life based on EORTC QLQ-BN20

    Time frame: 1 year

    Changes in quality of life during and after RT based on accepted EORTC brain tumor quality of life instruments administered each week on RT, 1 month post RT, and every 3 months subsequently

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

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

Acronym: UNITED

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2021
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.