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Radiation Therapy
Adaptive Radiotherapy for Glioblastoma (UNITED Trial)
N/A
Waitlist Available
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients aged 18 years and older
Histopathologically confirmed malignant glioma of the brain, Grade 4 (GBM)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
UNITED Trial Summary
This trial is testing a new way to give radiation therapy for brain tumors that may result in less side effects.
Who is the study for?
This trial is for adults over 18 with a specific brain tumor called Grade 4 glioblastoma, who can communicate in English and have an expected survival of more than 12 weeks. They should be fit enough for radiotherapy or chemo and have a tumor volume less than 150 cm3. It's not suitable for those unable to wear a head mask, with certain previous treatments, weight over 140 kg, MRI contraindications, or poor kidney function.Check my eligibility
What is being tested?
The study tests adaptive radiotherapy using MR-Linac technology on patients with high-grade gliomas. This method updates the treatment plan daily based on MRI scans to target tumors more precisely and reduce healthy brain tissue exposure compared to standard non-adaptive methods.See study design
What are the potential side effects?
Potential side effects may include typical radiation therapy risks such as skin irritation at the treatment site, fatigue, headaches, nausea, hair loss near treated areas and potential cognitive changes due to reduced exposure of healthy brain tissue.
UNITED Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My brain tumor is a confirmed Grade 4 glioma.
Select...
I am eligible for radiation therapy, with or without a specific chemotherapy drug.
Select...
I can perform light activities but not work.
Select...
My treatment area is smaller than 150 cm3.
UNITED Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Imaging-detected tumor recurrence at the edge of the radiation volume ("marginal" failure)
Secondary outcome measures
Acute radiation toxicity based on RTOG/EORTC Common Toxicity Criteria
Dexamethasone usage
Quality of life based on EORTC QLQ-BN20
+2 moreFind a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,551,329 Total Patients Enrolled
3 Trials studying Glioblastoma
105 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I weigh more than 140 kg or my waist is over 60 cm in circumference.I have had radiation therapy to my head before.I am 18 years old or older.I can speak and understand English well enough to answer questions.I cannot lie flat on my back for 30 minutes.Your doctor thinks you will live for more than 12 weeks.I am unable to understand and agree to the study's procedures and risks.My brain tumor is a confirmed Grade 4 glioma.I am eligible for radiation therapy, with or without a specific chemotherapy drug.My brain tumor is located below the tentorium or has spread thinly across multiple areas.I cannot have MRI contrast dyes due to an allergy or other health reasons.I can perform light activities but not work.I cannot wear a head thermoplastic mask due to discomfort or other reasons.My treatment area is smaller than 150 cm3.My kidney function is low, with an eGFR under 60 mL/min.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants can join this experiment?
"Affirmative. The clinicaltrial.gov site conveys that this medical trial, which opened on March 29th 2021, is still actively looking for participants. A total of 97 patients need to be enrolled from one location specifically."
Answered by AI
Are there opportunities for new participants to join this research endeavor?
"According to clinicaltrials.gov, this medical trial is currently recruiting participants. It was first published on March 29th 2021 and the information was most recently updated October 19th 2022."
Answered by AI
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