Radiation Therapy vs Observation for Meningioma

Recruiting at 210 trial locations

Overseen By C. Leland Rogers, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: NRG Oncology

Disqualifiers: Metastatic meningioma, Prior invasive malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 15

Duration: 6.5-7 weeks

163 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether radiation therapy is more effective than observation for patients with a specific type of brain tumor called grade II meningioma that has been completely removed by surgery. Radiation therapy uses high-energy x-rays to target and kill any remaining tumor cells. The trial seeks participants who have had a single grade II meningioma successfully removed through surgery. Participants will either undergo regular monitoring or receive radiation therapy to determine which approach better prevents tumor recurrence. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that radiation therapy for meningioma, a type of brain tumor, is generally well-tolerated. Studies have found that both photon and proton beam radiation effectively control tumor growth with a good safety record. For example, in cases of more aggressive meningiomas, patients experienced positive results with few serious side effects.

Proton beam therapy, in particular, has been studied for its safety. Reports indicate it maintains or even improves vision in 84% of patients with tumors near the optic nerve, suggesting its safety, especially given the importance of protecting healthy brain tissue.

Overall, radiation therapy for meningioma has demonstrated promising safety results. The treatment is well-researched and has been used effectively in similar conditions. Prospective trial participants can feel reassured by these findings. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it directly compares radiation therapy with clinical observation for managing meningioma, a common type of brain tumor. Unlike the traditional approach of immediate intervention, this trial investigates whether simply observing certain meningiomas can be just as effective as treatment with radiation, which typically involves intense sessions over several weeks. By exploring the possibility of observation as a viable option, this trial could lead to less aggressive management for patients, reducing exposure to potential side effects of radiation without compromising outcomes. This approach could significantly impact how we handle cases where the tumor shows slow or no growth.

What evidence suggests that radiation therapy could be effective for meningioma?

This trial will compare radiation therapy with clinical observation for treating meningiomas. Research has shown that radiation therapy effectively treats meningiomas, including grade II types. Specifically, studies indicate that intensity-modulated radiation therapy (IMRT) prevents most tumors from regrowing for five years in 93% of cases. Additionally, about 88% of patients live without their cancer worsening for five years, which is notably high. Proton therapy, another type of radiation, also yields excellent results and serves as a good alternative to traditional radiation treatments. These findings suggest that radiation therapy can effectively control meningiomas after surgery. Participants in this trial will either receive radiation therapy or undergo clinical observation. ^{3 5 6 7 8}

Who Is on the Research Team?

Michael A Vogelbaum

Principal Investigator

NRG Oncology

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

I've had a full physical and neurological exam within the last 60 days.

Exclusion Criteria

Major medical illnesses or psychiatric impairments which, in the investigator's opinion, will prevent administration or completion of the protocol therapy and/or preclude informed consent

I had a major heart attack in the last 6 months.

I have been diagnosed with Type II neurofibromatosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo either observation or radiation therapy (IMRT or proton beam) 5 days a week over 6.5-7 weeks for a total of 33 fractions

6.5-7 weeks

5 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits at 3, 6, and 12 months, every 6 months for years 2 and 3, then yearly for 10 years

10 years

Multiple visits over 10 years

What Are the Treatments Tested in This Trial?

Interventions

• Clinical Observation
• Radiation Therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm II (radiation therapy) Experimental Treatment 6 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 Control 5 Interventions

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

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 140 patients with intracranial meningiomas, adjuvant radiation therapy after subtotal resection significantly improved 5-year overall survival rates to 85% for benign tumors and 58% for malignant tumors, highlighting its efficacy in treatment.

The study found that for benign meningiomas, factors such as younger age and treatment after 1980 using advanced imaging techniques were associated with better progression-free survival rates, suggesting that modern treatment planning enhances outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative irradiation for subtotally resected meningiomas. A retrospective analysis of 140 patients treated from 1967 to 1990. Goldsmith, BJ., Wara, WM., Wilson, CB., et al.[2022]

A study involving 51 patients treated with a combination of photon and proton radiation therapy for benign meningiomas showed excellent acute tolerance and significant improvement in 68.8% of eye-related symptoms and 67% of other symptoms after a median follow-up of 25.4 months.

The treatment demonstrated a high local control rate of 98% and an overall survival rate of 100%, with minimal severe side effects, indicating that this combined radiation therapy is both effective and safe for managing intracranial meningiomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional outcome of patients with benign meningioma treated by 3D conformal irradiation with a combination of photons and protons. Noël, G., Bollet, MA., Calugaru, V., et al.[2019]

In a study involving 10 patients with atypical and anaplastic skull base meningioma, carbon ion therapy (12C) and proton therapy (IMPT) demonstrated significantly better target homogeneity and organ-at-risk sparing compared to intensity-modulated photon therapy (IMXT).

Dose escalation above 60 Gy(RBE) was achievable for four patients using ion beam therapies, indicating a potential for more aggressive treatment while minimizing damage to surrounding healthy tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of improved organ at risk sparing for meningioma: light ion beam therapy as boost versus sole treatment option. Mock, U., Georg, D., Sölkner, L., et al.[2018]

Particle therapy (PT) using protons or carbon ions has been shown to effectively control meningioma tumors, with a 5-year local tumor control rate of 85-99% for WHO grade I meningiomas, indicating its efficacy in treating these tumors while sparing surrounding healthy brain tissue.

For higher-grade meningiomas (WHO grade II or III), the local control rate is lower at 52%, suggesting that while PT is promising, its effectiveness may vary significantly based on tumor grade and previous treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton Therapy for Intracranial Meningioma for the Treatment of Primary/Recurrent Disease Including Re-Irradiation. Weber, DC., Bizzocchi, N., Bolsi, A., et al.[2021]

In a study of 44 patients with benign meningiomas treated with either 55.8 Gy or 63.0 Gy of combined proton-photon radiation therapy, local control rates were very high at 98% at 10 years and 90% at 15 years, indicating the treatment's effectiveness.

There was no significant difference in progression-free survival or overall survival between the two radiation dose levels, suggesting that increasing the dose may not provide additional benefits, while 59% of patients experienced late toxicities, including a notable risk of cerebrovascular accidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective, Randomized Study of Radiation Dose Escalation With Combined Proton-Photon Therapy for Benign Meningiomas. Sanford, NN., Yeap, BY., Larvie, M., et al.[2022]

Combined proton and photon radiotherapy is highly effective for treating recurrent or incompletely resected benign meningiomas, achieving a 5-year recurrence-free survival rate of 100% and an overall survival rate of 93% based on a study of 46 patients over a median follow-up of 53 months.

While the treatment is effective, there is a risk of severe long-term toxicity, particularly at higher doses, with 80% of patients surviving without severe side effects at 5 and 10 years; careful dose management is crucial to minimize complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benign meningioma: partially resected, biopsied, and recurrent intracranial tumors treated with combined proton and photon radiotherapy. Wenkel, E., Thornton, AF., Finkelstein, D., et al.[2019]

Particle-based radiotherapy for high-grade meningiomas shows promising local control rates between 46.7% and 86% and overall survival rates ranging from 0% to 100%, indicating its potential effectiveness as a treatment option.

The treatment has a relatively low risk of severe side effects, with radiation necrosis occurring in only 3.9% of cases, suggesting it may be safer than traditional photon-based therapies, although more controlled studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and toxicity of particle radiotherapy in WHO grade II and grade III meningiomas: a systematic review. Wu, A., Jin, MC., Meola, A., et al.[2020]

In a study of 21 patients treated for intracranial meningioma, radiotherapy showed a 5-year overall survival rate of 71% for benign tumors and 63% for malignant tumors, indicating its effectiveness in managing these conditions.

Patients receiving higher doses of radiotherapy (60 Gy or more) had significantly better survival rates (83%) compared to those receiving lower doses (43%), suggesting that higher radiation doses may improve outcomes for meningioma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Radiotherapy for intracranial meningioma: special reference to malignant and high risk benign meningioma]. Shimizu, T., Iijima, M., Tanaka, Y.[2011]

In a Phase I/II trial involving 10 patients with meningiomas, carbon ion radiation therapy (RT) combined with precision photon RT showed promising outcomes, with 5-year survival rates of 75% and local control rates of 86% for primary treatments.

The study suggests that carbon ion RT may be effective for atypical or anaplastic meningiomas, but further research with larger groups is necessary to confirm these findings and compare them to other radiation therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbon ion radiation therapy for high-risk meningiomas. Combs, SE., Hartmann, C., Nikoghosyan, A., et al.[2018]

High-precision photon radiotherapy demonstrated excellent long-term tumor control in patients with skull base meningiomas, achieving a local control rate of 95% at 5 years and 88% at 10 years, particularly for benign tumors.

The treatment was well tolerated, with minimal side effects and preservation of quality of life, as 47.7% of patients reported no change in their quality of life and 37.5% experienced improvement over a median follow-up of 107 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skull base meningiomas: Long-term results and patient self-reported outcome in 507 patients treated with fractionated stereotactic radiotherapy (FSRT) or intensity modulated radiotherapy (IMRT). Combs, SE., Adeberg, S., Dittmar, JO., et al.[2022]

The combination of conformal photon and proton radiation therapy for treating intracranial meningiomas showed high efficacy, with 4-year local control and overall survival rates of 87.5% and 88.9%, respectively, based on a study of 17 patients over a median follow-up of 37 months.

This treatment was well tolerated, leading to clinical improvements in most patients, and in 12 out of 15 recurrent cases, the time before disease recurrence was longer than after initial surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Highly conformal therapy using proton component in the management of meningiomas. Preliminary experience of the Centre de Protonthérapie d'Orsay. Noël, G., Habrand, JL., Mammar, H., et al.[2019]

In a study of 135 patients with atypical meningioma treated with adjuvant radiotherapy, higher radiation doses were linked to better local control, progression-free survival, and overall survival, indicating a clear dose-response relationship.

For every 1 Gy increase in radiation dose, there was a 12% reduction in local failure, tumor progression, and death, highlighting the importance of optimizing radiation dosage in treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-response relationship in patients with newly diagnosed atypical meningioma treated with adjuvant radiotherapy. Kim, D., Chang, WI., Byun, HK., et al.[2023]

Hypofractionated high-energy proton therapy is effective for treating WHO grade I meningiomas, achieving 93% progression-free survival at 5 years and 85% at 10 years in a study of 170 patients.

The treatment has an acceptable safety profile, with only 9.4% of patients experiencing radiation-related complications, primarily pituitary insufficiency, and is particularly beneficial for larger tumors that cannot be completely surgically removed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated high-energy proton-beam irradiation is an alternative treatment for WHO grade I meningiomas. Vlachogiannis, P., Gudjonsson, O., Montelius, A., et al.[2019]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0936655525001323

Effectiveness of Intensity Modulate Proton Therapy in ... First study exploring the potential dosimetric and radiobiological benefits of intensity-modulated proton therapy (IMPT) for multiple meningiomas.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/12128128/

Intensity-modulated radiation therapy (IMRT) for meningioma Results: Cumulative 5-year local control, progression-free survival, and overall survival were 93%, 88%, and 89%, respectively. Two patients progressed after ...

3. redjournal.org redjournal.org/article/S0360-3016%2824%2903525-9/fulltext

Radiation Therapy for Meningiomas – Where Do We Stand ... The reported median progression-free survival for 31 high-grade meningiomas was 25.7 months, with more favorable outcomes observed in grade 2 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10296362/

Long Term Outcome and Quality of Life of Intracranial ... This study shows that PBS PT is an adequate alternative to conventional radiotherapy in meningioma treatment.

5. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-13353-9

Proton therapy versus conventional radiotherapy for the ... Although literature reports excellent outcomes for intracranial meningioma patients treated by proton-therapy, none of the eight ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12552385/

Long-term outcomes and toxicity of radiotherapy for WHO ... High-precision photon and particle radiotherapy achieved effective long-term control with favorable safety in high-grade meningiomas. Most ...

7. academic.oup.com academic.oup.com/noa/article/6/1/vdae160/7763046

Analysis of safety and efficacy of proton radiotherapy for optic ... A stable or improved visual outcome can be reached in patients with optic nerve sheath meningiomas in up to 84% after proton beam radiotherapy.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2331518023001257

Clinical Outcomes of Recurrent Intracranial Meningiomas ... There are limited data guiding reirradiation (reRT), and proton beam radiation therapy (PBRT) offers a potential advantage owing to lower integral brain dose.