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

  • STATUS
    Recruiting
  • End date
    Mar 24, 2024
  • participants needed
    97
  • sponsor
    Sunnybrook Health Sciences Centre
Updated on 24 March 2022
cancer
MRI
residual tumor
malignant glioma
brain tumor

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.

Details
Condition Glioblastoma Multiforme
Treatment Reduced margin adaptive radiotherapy
Clinical Study IdentifierNCT04726397
SponsorSunnybrook Health Sciences Centre
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note