RECRUITING

Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma

Conditions

Meningioma Meningioma, Malignant Recurrent Meningioma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Pilot Trial of Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma (SRS-AIM)

Quick Facts

Study Start:2024-12-13

Study Completion:2029-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06557512

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * 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).	* 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.

Inclusion Criteria

Exclusion Criteria

* 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.
* 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).

* 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.

Contacts and Locations

Study Contact

Jamese Johnson

CONTACT

(415) 530-9805

Jamese.Johnson@ucsf.edu

Principal Investigator

William Chen, MD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94143

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

William Chen, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-13

Study Completion Date2029-09-30

Study Record Updates

Study Start Date2024-12-13

Study Completion Date2029-09-30

Terms related to this study

Additional Relevant MeSH Terms

Meningioma
Meningioma, Malignant
Recurrent Meningioma