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Radiation Therapy

Radiosurgery for Brain Cancer

N/A

Recruiting

Led By Wenyin Shi, MD

Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky performance status >= 60

Pathologically proven solid tumor malignancy (except for small cell lung cancer [SCLC], germ cell tumor)

Must not have

Intractable seizures while on adequate anticonvulsant therapy-more than 1 seizure per week for the past 2 months

Patient with diagnosis of glioma, or other World Health Organization (WHO) grade II - IV primary brain tumor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether SRS or SBRT help preserve neurological function in patients with multiple brain metastases.

Who is the study for?

This trial is for adults with solid tumor cancers, except SCLC and germ cell tumors, who have 1-10 brain metastases. They must be in good enough health to follow the study plan and complete cognitive tests. Pregnant women or those planning chemotherapy during radiosurgery are excluded.

What is being tested?

The trial is testing how stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT) affects neurological function in patients with multiple brain metastases. It aims to determine if SRS better preserves neurocognition than SBRT.

What are the potential side effects?

Potential side effects include typical reactions from radiation therapy such as headaches, fatigue, hair loss at treatment site, nausea, and potential short-term memory issues due to the focus on brain areas.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can care for myself but may need occasional help.

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I have a confirmed solid tumor cancer, not including small cell lung or germ cell tumors.

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My brain tumor or surgery area is 6 cm or smaller.

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My kidney function is within the required range.

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I have 1 to 10 brain tumors, with no more than two larger than 3 cm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had more than one seizure per week despite taking seizure medication.

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I have been diagnosed with a grade II-IV primary brain tumor.

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I will receive chemotherapy while undergoing radiosurgery.

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My cancer has spread to the lining of my brain and spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Neurocognitive function as measured by neurocognitive decline on a battery of tests

Secondary study objectives

Change in neurocognitive function as measured by neurocognitive decline on a battery of tests conducted by the primary investigator or a trained member of the clinical team

Change in symptom burden as measured by the MD Anderson Symptom Inventory- Brain Tumor Module (MDASI-BT)

Incidence of adverse events graded according to the Common Terminology Criteria for Adverse Events version 5.0

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Supportive care (SRS/SBRT, neurocognitive testing)Experimental Treatment4 Interventions

Patients undergo SRS on day 1 or SBRT for 3 fractions over days 1-7 and undergo neurocognitive testing at baseline, 4, and 12 months after undergoing SRS or SBRT.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Radiosurgery

2021

Completed Phase 2

~440

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~790