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 : February 18, 2022
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||97 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- Radiation: Reduced margin adaptive radiotherapy
Reduced (5 mm) clinical target volume margin with weekly contrast-enhanced adaptive radiation on the MR-Linac treatment machine
- 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.
- Tumor volume changes during RT [ Time Frame: 6 weeks ]Change in gross tumor volume (%) from start to end of RT
- 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
- 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
- Dexamethasone usage [ Time Frame: 10 weeks ]Amount of dexamethasone required during RT
- 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
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
|Contact: Jay Detsky, MD||416-480-6000 ext firstname.lastname@example.org|
|Contact: Arjun Sahgal, MD||416-480-6100 ext email@example.com|
|Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N3M5|
|Contact: Jay Detsky, MD 416-480-4806 firstname.lastname@example.org|