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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 6-24 months
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, anticipated 6-24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, anticipated 6-24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Changes in neurologic function
Health-related Quality of Life
Rate of toxicity
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Adaptive, two-phase RTExperimental Treatment1 Intervention
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Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
674 Previous Clinical Trials
1,565,815 Total Patients Enrolled
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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.
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