Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma

NCT06557512 | Recruiting DMC FDA Device

• 2 other identifiers: 24724NCI-2024-06542
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial tests the safety and effectiveness of hypofractionated stereotactic radiosurgery for treating patients who have undergone surgical resection for grade II meningiomas or grade I meningiomas that have come back after a period of improvement (recurrent). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Hypofractionated stereotactic radiosurgery may be safe, tolerable, and effective in treating patients with grade II or recurrent grade I meningiomas after surgical resection.

Conditions

Meningioma; Meningioma, Malignant; Recurrent Meningioma

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with reported adverse events

  Adverse events will be classified and graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The proportion of CTCAE grade 3-5 toxicity within 1 year of radiation will be estimated along with the exact 90% confidence interval.

  Up to 1 year

Secondary Outcomes (10)

• Median Local Freedom from recurrence (LFFR)

  Up to 3 years

• Median Progression-Free Survival (PFS)

  Up to 3 years

• Median overall survival (OS)

  Up to 3 years

• Mean score on the Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) over time

  Up to 3 months

• Frequency of responses on the Brief Work and Transportation Survey

  Up to 3 months

Study Arms (1)

Hypofractionated Stereotactic Radiosurgery (SRS)

EXPERIMENTAL

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

Radiation: Hypofractionated Stereotactic Radiosurgery (SRS); Procedure: Magnetic Resonance Imaging (MRI); Procedure: Computed Tomography (CT)

Interventions

Hypofractionated Stereotactic Radiosurgery (SRS) RADIATION

Undergo Hypofractionated Stereotactic Radiosurgery

Also known as: Fractionated Stereotactic Radiation Therapy, SRS

Hypofractionated Stereotactic Radiosurgery (SRS)

Magnetic Resonance Imaging (MRI) PROCEDURE

Undergo MRI

Also known as: MRI, MR

Hypofractionated Stereotactic Radiosurgery (SRS)

Computed Tomography (CT) PROCEDURE

Undergo CT imaging

Also known as: CT

Hypofractionated Stereotactic Radiosurgery (SRS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>+ 18 years at time of study entry
• Ability to understand and the willingness to sign a written informed consent document.
• Histologic diagnosis of newly diagnosed World Health Organization (WHO) grade 2 or recurrent WHO grade 1 meningioma. With regard to recurrent WHO grade 1 meningioma, participants must present with radiographic evidence of recurrence, and have a histologic diagnosis of WHO grade 1 meningioma at the most recent resection.
• \* Note: For participants diagnosed outside of University of California San Francisco (UCSF), re-review of pathology at UCSF is strongly encouraged. Hematoxylin and eosin (H\&E) slides will be reviewed by UCSF pathologists.
• Participants must have undergone a gross-total surgical resection as deemed by their neurosurgeon (Simpson grade I-III resection), using all available information which can include post-operative MRI, of a meningioma within 180 days of enrollment.
• Participants must have a pre-operative MRI.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky score of 70 or higher)
• Participants must have post-operative MRI indicating anatomy suitable for hypofractionated radiosurgery, as reviewed by the Radiation Oncology co-principal investigators (PIs).

You may not qualify if:

• 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.
• Extensive multifocal (3 or more meningiomas) or metastatic disease.
• Participants with tumors within 2mm of the optic apparatus or brainstem will be excluded.
• Participants with another active primary malignancy or history of previous malignancy (except non-melanoma skin cancers, low and favourable-intermediate risk prostate cancers, and in situ cancers such as bladder, gastric, colon, cervical/dysplasia, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period.
• Female participants who are pregnant.
• Any underlying medical or psychiatric condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of participant safety or study results.
• Participants with uncontrolled seizures, defined as greater than 3 disabling seizures per day while on anti-epileptic drugs.
• Participants who have had previous intracranial radiotherapy overlapping with the area that would be targeted for stereotactic radiosurgery by this study.

Sponsors & Collaborators

• University of California, San Francisco: lead
• American Society of Clinical Oncology: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Meningioma

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• William Chen, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamese Johnson

CONTACT

(415) 530-9805; Jamese.Johnson@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 16, 2024
• Study Start: December 13, 2024
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: January 8, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)