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

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ClinicalTrials.gov Identifier: NCT04726397
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : September 21, 2021
Sponsor:
Information provided by (Responsible Party):
Jay Detsky, Sunnybrook Health Sciences Centre

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.


Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Radiation: Reduced margin adaptive radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: UNIty-Based MR-Linac Guided AdapTive RadiothErapy for High GraDe Glioma: A Phase 2 Trial (UNITED Trial)
Actual Study Start Date : March 29, 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine



Intervention Details:
  • Radiation: Reduced margin adaptive radiotherapy
    Reduced (5 mm) clinical target volume margin with weekly contrast-enhanced adaptive radiation on the MR-Linac treatment machine


Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04726397


Contacts
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Contact: Jay Detsky, MD 416-480-6000 ext 4806 jay.detsky@sunnybrook.ca
Contact: Arjun Sahgal, MD 416-480-6100 ext 4998 arjun.sahgal@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Jay Detsky, MD    416-480-4806    jay.detsky@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
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Responsible Party: Jay Detsky, Radiation Oncologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04726397    
Other Study ID Numbers: 3412
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue