What side effects are associated with this type of intervention?

Radiation therapy, commonly used to treat meningiomas, involves high-energy x-rays to kill tumor cells and shrink tumors. Known side effects of this treatment include radiation necrosis, characterized by tissue damage and cerebral edema, which can lead to focal neurologic symptoms. Other potential complications are cognitive decline, particularly with whole-brain radiotherapy, and an increased risk of secondary cancers. Acute and subacute radiation encephalopathy may also occur, presenting with headaches, nausea, and focal neurologic deficits. Long-term effects can include leukoencephalopathy and other neurocognitive impairments.

What prior FDA approvals exist?

The treatment of meningioma, particularly atypical and malignant types, often involves radiation therapy to improve local control and progression-free survival after surgical resection. While specific FDA approvals for radiation therapy in meningioma are not detailed, this modality is a well-established treatment approach. Studies have shown that adjuvant radiation therapy, such as external beam radiation, can significantly reduce the risk of tumor recurrence. Other investigational treatments, including brachytherapy and systemic therapies, are also being explored to enhance outcomes for patients with refractory or recurrent meningiomas.

What other types of research exist?

Promising novel alternatives to traditional radiation therapy for meningioma patients include proton beam therapy, which offers precise targeting with minimal damage to surrounding tissues, and investigational therapies such as chimeric antigen receptor (CAR) T-cell therapy targeting specific tumor markers. Additionally, advanced imaging-guided techniques like intensity-modulated radiation therapy (IMRT) and stereotactic radiosurgery (SRS) are also being explored for their potential to improve outcomes with fewer side effects.

Other

Radiation Therapy vs Observation for Meningioma

Columbia, MO

Phase 3

Recruiting

Led By Michael A Vogelbaum

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

Must not have

Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration

Type II neurofibromatosis (NF2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to disease-related death, assessed up to 10 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial studies if radiation therapy helps prevent the return of grade II meningioma after surgery. Radiation therapy uses powerful x-rays to destroy any leftover cancer cells. The goal is to see if this improves patient outcomes compared to just monitoring them. Radiation therapy has shown success in stabilizing tumor growth and reducing recurrence risk.

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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 below

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My meningioma is confirmed to be grade II by a specialized review.

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I have a newly diagnosed, single brain tumor (meningioma) that has been completely removed and confirmed as grade II.

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My meningioma is confirmed to be grade II by a central pathology review.

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I registered for the trial within 6 months of my first surgery, even if I had a second one.

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My surgery removed all visible tumor, confirmed by MRI.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on IV antibiotics for a bacterial or fungal infection.

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I have been diagnosed with Type II neurofibromatosis.

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I do not have a severe lung condition that requires hospital care right now.

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I have conditions that make radiation therapy riskier for me.

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I have had radiation therapy on my head and now have tumors in the lining of my brain.

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I have a specific type of tumor affecting my optic nerve, spine, or other areas outside the brain.

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I have not been hospitalized for heart issues at the time of step 2 registration.

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My meningioma has spread to other parts of my body.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to disease-related death, assessed up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to disease-related death, assessed up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to disease-related death, assessed up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression free survival (PFS)

Secondary study objectives

Change in neurocognitive function (NCF) assessed by MD Anderson Symptom Inventory with Brain Tumor (MDASI-BT)

Change in patient reported outcomes (PRO) as assessed by MDASI-BT

DSS rates

+7 more

Awards & Highlights

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.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (radiation therapy)Experimental Treatment6 Interventions

Patients undergo IMRT or proton beam radiation therapy 5 days a week over 6.5-7 weeks for a total of 33 fractions in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and blood collection throughout the study.

Group II: Arm I (observation)Active Control5 Interventions

Patients undergo observation. Additionally, patients undergo MRI and blood collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~1810

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~2070

Magnetic Resonance Imaging

2020

Completed Phase 3

~1180

Proton Beam Radiation Therapy

2013

Completed Phase 2

~110

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Radiation therapy, a common treatment for meningioma, works by using high-energy x-rays to target and kill tumor cells, thereby shrinking the tumor. This is crucial for meningioma patients as it can reduce tumor size, alleviate symptoms, and potentially improve survival rates. Understanding this mechanism allows for better optimization of treatment plans and helps in minimizing side effects, making it a vital component in the management of meningioma.