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

NCT ID: NCT04726397

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-29

Study Completion Date

2024-05-15

Brief Summary

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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.

Detailed Description

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Conditions

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Glioblastoma Multiforme

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Reduced margin adaptive radiotherapy

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Jay Detsky

Radiation Oncologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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3412

Identifier Type: -

Identifier Source: org_study_id