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Adjuvant Hypofractionated Stereotactic Radiosurgery for Intermediate-risk Meningioma

ConditionsMeningiomaMeningioma, MalignantRecurrent Meningioma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Hypofractionated Stereotactic Radiosurgery (SRS)

    Radiation

    Undergo Hypofractionated Stereotactic Radiosurgery

  • Magnetic Resonance Imaging (MRI)

    Procedure/Surgery

    Undergo MRI

  • Computed Tomography (CT)

    Procedure/Surgery

    Undergo CT imaging

Treatment groups

23 Participants
are divided into 1 treatment group
Group A: Hypofractionated Stereotactic Radiosurgery (SRS)Experimental treatment 3 interventions

Trial outcomes

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.

Time frame
Up to 1 year

Secondary outcomes

1

Median Local Freedom from recurrence (LFFR)

Local freedom from recurrence (LFFR) is defined as time from start of treatment to date of an event as defined by the above criteria, dated to the imaging study date on which recurrence was assessed. The 3-year LFFR will be estimated by the Kaplan-Meier method. Median LFFR will be estimated, if possible, from the Kaplan-Meier method.

Time frame
Up to 3 years
2

Median Progression-Free Survival (PFS)

Progression free survival (PFS) is defined as the duration of time from start of treatment to date of death or progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, dated to the imaging study date on which PD was assessed. The 3-year PFS will be estimated by the Kaplan-Meier method. Median PFS will be estimated, if possible, from the Kaplan-Meier method.

Time frame
Up to 3 years
3

Median overall survival (OS)

Overall survival (OS) is defined as the duration of time from start of treatment to date of death or censored at the date of final visit if lost to follow-up. The 3-year OS will be estimated by the Kaplan-Meier method. Median OS will be estimated, if possible, from the Kaplan-Meier method.

Time frame
Up to 3 years
4

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

The COST-FACIT is an 11-item measure used to assess financial toxicity. Each item is measured on a five-point Likert scale (0 = not at all, 4 = very much), with recall based on the past 7 days related to the participant's disease management. A score is computed by first reverse coding seven items, then taking the sum of all items, multiplying the sum by 1the number of items on the scale, and dividing that number by the number of items answered. Higher scores indicate better Financial Well-Being.

Time frame
Up to 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

American Society of Clinical Oncology

Collaborator

Source ClinicalTrials.gov
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