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

NCT04726397 | Completed

• 1 other identifier: 3412
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

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

  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.

  Within 1 year from end of radiation

Secondary Outcomes (5)

• Tumor volume changes during RT

  6 weeks

• Acute radiation toxicity based on RTOG/EORTC Common Toxicity Criteria

  6 weeks

• Quality of life changes based on EORTC QLQ-C30

  1 year

• Dexamethasone usage

  10 weeks

• Quality of life based on EORTC QLQ-BN20

  1 year

Interventions

Reduced margin adaptive radiotherapy RADIATION

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 27, 2021
• Study Start: March 29, 2021
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)