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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

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 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

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
Cognitive Assessment
2011
Completed Phase 2
~1420

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,910 Total Patients Enrolled
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
162 Previous Clinical Trials
10,821 Total Patients Enrolled
Wenyin Shi, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University
2 Previous Clinical Trials
155 Total Patients Enrolled

Media Library

Stereotactic Body Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03184038 — N/A
Cancer Research Study Groups: Supportive care (SRS/SBRT, neurocognitive testing)
Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy Highlights & Side Effects. Trial Name: NCT03184038 — N/A
Stereotactic Body Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03184038 — N/A
~0 spots leftby Sep 2024
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