Status:
COMPLETED
UNIty-Based MR-Linac Guided AdapTive RadiothErapy for High GraDe Glioma: a Phase 2 Trial
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
NA
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. Radiati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2024
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04726397
Start Date
March 29 2021
End Date
May 15 2024
Last Update
November 29 2024
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5