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Radiation Therapy
Targeted Radiation Therapy for Brain Cancer (CogRT Trial)
N/A
Recruiting
Led By Sahaja Acharya, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if better radiation planning can reduce brain impairment for kids with brain tumors. It will compare the effects of different radiation treatments on the brain.
Who is the study for?
This trial is for children and young adults aged 1 to <26 with new brain or head and neck tumors needing radiation therapy. It includes those who finished radiation at least two years ago without recurrence, and healthy kids for comparison.
What is being tested?
The study tests if targeting radiation more precisely to protect brain areas important for thinking can reduce learning impairments. Participants undergo neurocognitive testing and MRI scans to assess the impact of different radiation plans.
What are the potential side effects?
While not a treatment, this trial involves risks from additional MRIs like discomfort or reactions in claustrophobic patients, plus potential distress from extra neurocognitive testing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of plans that meet substructure-informed planning constraints
Secondary study objectives
Cumulative incidence of local and distant tumor recurrence
Fractional anisotropy values
characterize longitudinal CVLT scores in survivors of pediatric brain tumor who are ≥ 2 years post radiation
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Stratum C (healthy controls matched to Stratum A)Experimental Treatment2 Interventions
Healthy patients who are matched to Stratum A patients
Group II: Stratum B (patients ≥ 2 years after standard radiation therapy)Experimental Treatment2 Interventions
Patients who completed radiation therapy under standard planning procedures ≥ 2 years ago.
Group III: Stratum A (new diagnosis, substructure informed radiation therapy)Experimental Treatment3 Interventions
Patients will undergo radiation therapy which has been planned according to dose constraints to specific brain substructures.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI
2009
Completed Phase 2
~2810
Find a Location
Who is running the clinical trial?
United States Department of DefenseFED
910 Previous Clinical Trials
333,393 Total Patients Enrolled
Clark Charitable FoundationUNKNOWN
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
570 Previous Clinical Trials
32,892 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 5 and 25 years old and can undergo imaging tests without needing sedation.I am not pregnant, can undergo brain function tests, and do not have conditions like Down's syndrome or autism.I have a major psychiatric, neurologic, or medical condition.I was diagnosed with a brain tumor before 26, had brain radiation over 2 years ago, and my tumor hasn't come back since.I am between 1 and 25 years old with a brain tumor receiving radiation therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Stratum A (new diagnosis, substructure informed radiation therapy)
- Group 2: Stratum B (patients ≥ 2 years after standard radiation therapy)
- Group 3: Stratum C (healthy controls matched to Stratum A)
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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