Your session is about to expire
← Back to Search
Other
Radiation Therapy vs Observation for Meningioma
Phase 3
Recruiting
Led By C. Leland Rogers, MD
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed diagnosis of WHO grade II meningioma confirmed by central pathology review prior to step 2 registration
Patient must have a newly diagnosed unifocal intracranial meningioma, gross totally resected, and histologically confirmed as WHO grade II based upon pathology findings at the enrolling institution
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years after randomization
Awards & highlights
Study Summary
This trial compares radiation therapy with observation in treating patients with newly diagnosed grade II meningioma.
Who is the study for?
This trial is for patients with a specific brain tumor called Grade II meningioma, which has been fully removed by surgery. Participants must have had a complete surgical removal confirmed by MRI and be in good physical condition. Pregnant women can't join, and those who might get pregnant agree to use birth control if they receive radiation.Check my eligibility
What is being tested?
The study compares the effectiveness of post-surgery observation versus radiation therapy in patients with newly diagnosed Grade II meningioma that was surgically removed. Radiation therapy involves high-energy x-rays aimed at killing any remaining tumor cells.See study design
What are the potential side effects?
Radiation therapy may cause headaches, fatigue, hair loss at the treatment site, skin irritation like redness or dryness, nausea, and could potentially affect brain function depending on the area treated.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My meningioma is confirmed to be grade II by a specialized review.
Select...
I have a newly diagnosed, single brain tumor (meningioma) that has been completely removed and confirmed as grade II.
Select...
My meningioma is confirmed to be grade II by a central pathology review.
Select...
I registered for the trial within 6 months of my first surgery, even if I had a second one.
Select...
My surgery removed all visible tumor, confirmed by MRI.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years after randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years after randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-Free Survival (PFS)
Secondary outcome measures
3 Year Disease-Specific Survival (DSS)
3 Year Progression-Free Survival (PFS)
5 Year Disease-Specific Survival (DSS)
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (Radiation Therapy)Experimental Treatment1 Intervention
Patients undergo radiation therapy 5 days a week over 6.5-7 weeks for a total of 33 fractions after gross total resection.
Group II: Arm I (Clinical Observation)Experimental Treatment1 Intervention
Patients undergo observation after gross total resection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,706 Total Patients Enrolled
45 Trials studying Meningioma
4,089 Patients Enrolled for Meningioma
NRG OncologyLead Sponsor
231 Previous Clinical Trials
100,704 Total Patients Enrolled
1 Trials studying Meningioma
244 Patients Enrolled for Meningioma
C. Leland Rogers, MDPrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials
244 Total Patients Enrolled
1 Trials studying Meningioma
244 Patients Enrolled for Meningioma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My meningioma is confirmed to be grade II by a specialized review.I had a major heart attack in the last 6 months.I speak English, French, or Spanish and will participate in the study's surveys.I have a newly diagnosed, single brain tumor (meningioma) that has been completely removed and confirmed as grade II.I am currently on IV antibiotics for a bacterial or fungal infection.I have been diagnosed with Type II neurofibromatosis.I do not have a severe lung condition that requires hospital care right now.I have conditions that make radiation therapy riskier for me.You cannot have an MRI with or without a special dye called gadolinium.I've had a full physical and neurological exam within the last 60 days.My surgery removed all visible cancer, confirmed by MRIs before and after surgery.I have been cancer-free for at least 3 years, except for non-melanoma skin cancer.My meningioma is confirmed to be grade II by a central pathology review.I have had radiation therapy on my head and now have tumors in the lining of my brain.I registered for the trial within 6 months of my first surgery, even if I had a second one.I have a specific type of tumor affecting my optic nerve, spine, or other areas outside the brain.My neurosurgeon has determined my Simpson grade for surgery.I have not been hospitalized for heart issues at the time of step 2 registration.My surgery removed all visible tumor, confirmed by MRI.My meningioma has spread to other parts of my body.I have been mostly active and able to carry on all pre-disease activities without restriction after surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (Clinical Observation)
- Group 2: Arm II (Radiation Therapy)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Meningioma Patient Testimony for trial: Trial Name: NCT03180268 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the target number of people that should enroll in this clinical trial?
"One hundred and forty-eight volunteers are necessary to complete this study. Inclusion criteria must be met to be eligible. Patients can go to UC Irvine Health/Chao Family Comprehensive Cancer Center in Orange, California or AdventHealth Orlando in Orlando, Florida to participate."
Answered by AI
Can people with the necessary qualifications join this clinical trial at this time?
"Indeed, this clinical trial is still looking for participants. According to the website, the posting went up on 6/14/2017 and the most recent update was on 8/29/2022."
Answered by AI
Is Radiation Therapy a risky treatment for patients?
"Radiation Therapy has been studied extensively and is considered safe."
Answered by AI
Who else is applying?
What state do they live in?
Wisconsin
What site did they apply to?
Marshfield Medical Center-EC Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
Need some extra money.
PatientReceived 2+ prior treatments
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger