Stereotactic Radiosurgery for Meningioma

(SRS-AIM Trial)

Overseen By Jamese Johnson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Multifocal disease, Tumors near brainstem, Active malignancy, Uncontrolled seizures, others

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

Compensation: Varies

Number of Visits: 8

Duration: 1 week

23 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new radiation treatment to determine its safety and effectiveness for people with certain brain tumors called meningiomas. It targets individuals with either a grade II meningioma or a grade I meningioma that has returned after treatment. The treatment, hypofractionated stereotactic radiosurgery, is a precise radiation therapy that delivers high doses over a shorter period to target the tumor. This trial may suit those who have undergone surgery to remove their meningioma and have a recent MRI showing the tumor's location is suitable for this radiation therapy. As an unphased trial, it provides access to innovative treatment options not yet widely available.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that hypofractionated stereotactic radiosurgery is safe for treating meningiomas?

Research has shown that hypofractionated stereotactic radiosurgery, a precise type of radiation treatment, is generally safe and well-tolerated. Studies have found it effective for treating brain tumors, such as meningiomas. This treatment delivers higher doses of radiation over a short period, potentially leading to fewer side effects compared to traditional methods.

A thorough review found that patients who received this treatment had a high overall survival rate, indicating it is a reliable option. Another study confirmed that this radiosurgery safely manages intracranial meningiomas, a type of brain tumor. While every treatment carries some risks, current evidence supports the safety of this approach for treating meningiomas after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for meningioma, which often involve prolonged radiation therapy over several weeks, hypofractionated stereotactic radiosurgery (SRS) is unique because it delivers high doses of radiation in a much shorter timeframe—just 15-30 minutes per day over five days. This precision-focused method targets the tumor with minimal impact on surrounding healthy tissue, potentially reducing side effects. Researchers are excited about this approach because it offers a more convenient and less taxing treatment schedule for patients without compromising effectiveness.

What evidence suggests that hypofractionated stereotactic radiosurgery is effective for meningioma?

Research has shown that hypofractionated stereotactic radiosurgery, which participants in this trial will undergo, holds promise for treating meningiomas, a type of brain tumor. One study found that 85.2% of patients did not experience tumor growth, and 91.0% were still alive after five years. This indicates that most patients' tumors did not return, and a high percentage survived five years later. Another study found that this treatment led to better survival rates compared to other methods. Additionally, side effects were relatively low, with only 3.2% of patients experiencing severe long-term effects. These findings suggest that hypofractionated stereotactic radiosurgery can be both safe and effective for certain types of meningiomas. ^{2 3 4 6 7}

Who Is on the Research Team?

William Chen, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for patients who've had surgery for grade II meningiomas or recurrent grade I meningiomas. It's testing a shorter, high-dose radiation therapy called hypofractionated stereotactic radiosurgery (SRS) to see if it's safe and effective in treating these tumors.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document

I had surgery to remove a brain tumor completely within the last 6 months.

My post-surgery MRI shows I'm a candidate for targeted radiation therapy.

Exclusion Criteria

Any underlying medical or psychiatric condition that would interfere with evaluation of study treatment or interpretation of participant safety or study results

Concurrent participation in another clinical study with an investigational product unless it is an observational (non-interventional) study or the follow-up period of an interventional study

I have seizures that are not controlled by medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo hypofractionated stereotactic radiosurgery over 15-30 minutes once daily on days 1-5

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Follow-up at months 3 and 6, then annually up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Stereotactic Radiosurgery

Trial Overview The study involves using advanced imaging techniques like CT and MRI to guide the SRS treatment. The goal is to precisely target tumor cells with higher doses of radiation over fewer sessions, potentially improving outcomes and reducing side effects.

How Is the Trial Designed?

Group I: Hypofractionated Stereotactic Radiosurgery (SRS) Experimental Treatment 3 Interventions

Participants undergo hypofractionated stereotactic radiosurgery over 15-30 minutes QD on days 1-5 in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

American Society of Clinical Oncology

Collaborator

Trials

40

Recruited

148,000+

Published Research Related to This Trial

In a study of 31 patients with intracranial meningiomas treated with hypofractionated stereotactic radiation therapy, the five-year overall survival rate was 86% and the progression-free survival rate was 83%, indicating the treatment's efficacy over a median follow-up of 48 months.

The study found that larger tumor volumes (specifically, a planning target volume greater than 11 cm³) were significantly associated with the development of peritumoral edema, suggesting that tumor size is an important factor to consider when evaluating treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significance of tumor volume related to peritumoral edema in intracranial meningioma treated with extreme hypofractionated stereotactic radiation therapy in three to five fractions. Morimoto, M., Yoshioka, Y., Shiomi, H., et al.[2022]

Stereotactic radiosurgery using a hypofractionated regimen shows promising long-term tumor control and overall survival rates for patients with recurrent WHO grade II meningiomas, with a 60-month survival rate of 87%.

For WHO grade III meningiomas, while the recurrence rate is higher at 66%, the treatment still provides a viable option, although with a lower overall survival rate of 50% at 12 months and a notable complication rate of 7.5%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CyberKnife Stereotactic Radiosurgery for Atypical and Malignant Meningiomas. Zhang, M., Ho, AL., D'Astous, M., et al.[2017]

In a study of 70 patients treated with moderately hypofractionated IMRT (30 Gy at 3 Gy per fraction) for benign meningiomas or schwannomas, the local control rate was an impressive 92.9% after a median follow-up of 3.2 years.

The treatment was well-tolerated, with only 2.9% of patients experiencing disease progression and one case of asymptomatic radiation necrosis that resolved without intervention, making it a convenient option for patients who may not tolerate longer treatment regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderately Hypofractionated Radiation for Benign Meningiomas and Schwannomas: A Report of 70 Patients Treated Between 2008 and 2018. Dhere, VR., Tian, S., Buchwald, Z., et al.[2022]

In a study of 231 patients with intracranial meningiomas treated with the CyberKnife system over 27 months, tumor growth was successfully controlled in 100% of WHO grade I tumors, 66.7% of grade II tumors, and 60% of grade III tumors, demonstrating the efficacy of this treatment.

While the CyberKnife treatment was effective, 16% of patients experienced deterioration after radiation, with some cases linked to radiation-induced reactions, indicating the need for careful monitoring and further research on treatment standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Early results of irradiation of intracranial meningiomas using CyberKnife]. Galkin, MV., Golanov, AV., Zolotova, SV., et al.[2018]

In a study of 273 patients with large benign meningiomas treated with single-session stereotactic radiosurgery, the tumor control rate was 90% and the 5-year progression-free survival rate was 96%.

The treatment was found to be safe, with only 15% of patients experiencing temporary adverse radiation effects, and a high percentage (96%) of patients with perioptic meningiomas reported favorable visual outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-Session Stereotactic Radiosurgery for Large Benign Meningiomas: Medium-to Long-Term Results. El-Shehaby, AMN., Reda, WA., Abdel Karim, KM., et al.[2021]

A prospective phase 2 trial involving 178 patients demonstrated that a hypofractionated radiosurgery schedule of 25 Gy in 5 fractions is safe, with a low overall toxicity rate of 12.7%, and only 11.7% at 5 years follow-up.

The treatment showed excellent efficacy, achieving a 5-year local tumor control rate of 97%, indicating that this approach is effective for managing large and critically located grade 1 intracranial meningiomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated Radiosurgery for Large or in Critical-Site Intracranial Meningioma: Results of a Phase 2 Prospective Study. Pinzi, V., Marchetti, M., Viola, A., et al.[2023]

In a study of 220 skull base meningiomas treated with different radiation techniques, there was no significant difference in tumor control or clinical response among stereotactic radiosurgery (SRS), hypofractionated stereotactic radiotherapy (hFSRT), and fractionated stereotactic radiotherapy (FSRT).

The median follow-up was 32 months, and the results suggest that treatment can be tailored based on tumor size and location, as all methods achieved high rates of radiographic control (91-95%) and clinical response (89-100%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study of stereotactic radiosurgery, hypofractionated, and fractionated stereotactic radiotherapy in the treatment of skull base meningioma. Han, J., Girvigian, MR., Chen, JC., et al.[2022]

In gamma knife radiosurgery for intracranial meningiomas, a linear relationship was found between treatment volume and the likelihood of complications at a dose of 15 Gy, indicating that larger treatment volumes may increase risk.

The study suggests that the 3% isodose curve can serve as a guideline for dose selection, as patients treated below this curve experienced no complications, while those above it had a significantly higher complication rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-volume effect in gamma knife radiosurgery of meningiomas. Kang, CS., Zheng, LG., Xu, DS.[2018]

In a study of 75 patients with WHO Grade I meningiomas treated with stereotactic radiosurgery (SRS), 52% showed no volumetric tumor growth, while 92% had stable diametric measurements, indicating that SRS is effective in controlling tumor growth in most cases.

A lower conformity index was significantly linked to the development of edema post-SRS, suggesting that careful planning of radiation delivery can help minimize adverse effects like swelling in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of response to Gamma Knife radiosurgery for intracranial meningiomas. Mansouri, A., Larjani, S., Klironomos, G., et al.[2022]

Hypofractionated stereotactic radiotherapy (hFSRT) was well tolerated in a study of 35 patients with intracranial meningiomas, showing no significant acute or late toxicity, which suggests a favorable safety profile for this treatment.

After a median follow-up of 29 months, 91% of treated lesions remained stable, and 84% of patients experienced clinical improvement in neurological symptoms, indicating that hFSRT is an effective treatment option for managing meningiomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated stereotactic radiotherapy for intracranial meningiomas: preliminary results of a feasible trial. Trippa, F., Maranzano, E., Costantini, S., et al.[2022]

Moderate hypofractionated stereotactic radiotherapy (hFSRT) demonstrated a high local control rate of 84% for intracranial meningiomas over a median follow-up of 56 months, making it an effective treatment option.

The treatment was found to be safe, with no significant acute or late toxicities reported, and it offers a lower number of treatment fractions, which reduces discomfort for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcome of moderate hypofractionated stereotactic radiotherapy for meningiomas. Maranzano, E., Draghini, L., Casale, M., et al.[2022]

In a study of 38 patients with skull base meningiomas treated with hypofractionated stereotactic radiotherapy (SRT), the treatment showed promising efficacy, with no patients experiencing radiological progression and 6 patients reporting symptom resolution after a median follow-up of 47 months.

The treatment was well-tolerated, with most patients remaining unchanged in their condition, suggesting that hypofractionated SRT is a safe and effective option for managing benign CNS tumors, especially when considering resource allocation and patient tolerance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of hypofractionated stereotactic radiotherapy in treatment of skull base meningiomas. Gorman, L., Ruben, J., Myers, R., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8482200/

Hypofractionated Stereotactic Radiotherapy for the Treatment ... The five-year PFS and OS were 85.2% and 91.0%, respectively. The late grade III/IV toxicity rate was 3.2% and the radionecrosis rate was 4.8%.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06557512

Study Details | NCT06557512 | Adjuvant Hypofractionated ... Hypofractionated stereotactic radiosurgery may be safe, tolerable, and effective in treating patients with grade II or recurrent grade I meningiomas after ...

3. nature.com nature.com/articles/s41598-018-32124-8

Hypofractionated Stereotactic Radiotherapy for Patients ... in 50 patients receiving SRS for grades II and III meningiomas showed LC levels of 85% and 45% at one and five years, respectively. These ...

4. redjournal.org redjournal.org/article/S0360-3016(22)03236-9/fulltext

Hypofractionated Radiosurgery for Large or in Critical-Site ... We carried out a prospective phase 2 trial, aiming to establish whether a fractionated RS schedule of 25 Gy in 5 fractions would be safe and effective.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0967586825003571

Efficacy and safety of stereotactic radiosurgery for large ... Hypofractionated SRS (99 % [95 % CI: 91 %–100 %]) was associated with a significantly higher pooled OS rate than volume-staged SRS (82 % [95 % CI: 69 %–92 %]) ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40505253/

A comprehensive systematic review and meta-analysis Hypofractionated SRS (99 % [95 % CI: 91 %-100 %]) was associated with a significantly higher pooled OS rate than volume-staged SRS (82 % [95 % ...

7. thejns.org thejns.org/focus/view/journals/neurosurg-focus/46/6/article-pE2.xml

a systematic review and meta-analysis in These findings are consistent with a previous meta-analysis of skull base meningiomas that reported a local tumor control rate at 5 years with SRT of 85%–100%, ...