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Radiation Therapy
Adaptive Radiotherapy for Glioblastoma (UNITED-3 Trial)
N/A
Recruiting
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, anticipated 12-24 months
Awards & highlights
UNITED-3 Trial Summary
This trial will test an adaptive two-phase radiation therapy approach to see if it better controls glioblastoma than standard radiation therapy. It will also monitor survival, side effects and quality of life.
Who is the study for?
This trial is for adults with newly diagnosed glioblastoma or grade 4 astrocytoma. They must have had a biopsy or surgery within the last 12 weeks, good blood counts and organ function, an expected survival of at least 12 weeks, and be in fair to good physical condition. Participants need to understand English for questionnaires and commit to treatment follow-up.Check my eligibility
What is being tested?
The study tests an adaptive two-phase radiation therapy (RT) against standard RT in patients with glioblastoma. It aims to see if this new method improves tumor control, survival rates without disease progression, failure patterns, toxicity impact on neurological functions, and life quality.See study design
What are the potential side effects?
While not specified here, typical side effects of radiation therapy may include fatigue, skin reactions at the treatment site like redness or irritation; headaches; nausea; hair loss around treated area; and potential cognitive changes.
UNITED-3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, anticipated 12-24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, anticipated 12-24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of marginal failure (if 20-80% of the recurrent GTV (rGTV) falls within the 95% isodose line)
Secondary outcome measures
Adaptive Radiation Dosimetry
Changes in neurologic function
Functional Imaging Kinetics as a Correlate of Treatment Response
+6 moreUNITED-3 Trial Design
1Treatment groups
Experimental Treatment
Group I: Adaptive, two-phase RTExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,551,268 Total Patients Enrolled
3 Trials studying Glioblastoma
173 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have MRI contrast dyes due to an allergy or other health issue.My cancer has spread to the lining of my brain and spinal cord.I have had radiation therapy to the head before.I cannot lie flat for 30 minutes.I cannot tolerate being immobilized in a head mask.I weigh more than 140 kg or my waist is over 60 cm.I have had cancer before, but it was either skin cancer treated successfully or another type of cancer that has been gone for over 2 years.My doctor thinks it's suitable for me to have radiation and medication treatment together.I had a biopsy or surgery for my condition within the last 12 weeks.My blood, kidney, and liver tests are within normal ranges.My diagnosis is glioblastoma or grade 4 astrocytoma.I can take care of myself and perform daily activities.My kidney function is good enough for the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Adaptive, two-phase RT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum capacity of this research program?
"Affirmative, clinicaltrials.gov reveals that recruitment for this trial is still ongoing; the listing was first posted on April 1st 2023 and recently updated on April 13th 2023. There is a need for 40 participants at one location."
Answered by AI
Are there any available slots for participants in this experiment?
"That is affirmatively correct. As per the information provided on clinicaltrials.gov, this clinical trial has been recruiting patient since April 1st 2023 and was last updated on April 13th 2023. The enrolment size for this study comprises of 40 individuals at one site."
Answered by AI
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