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Radiation Therapy

Radiosurgery for Brain Cancer

Phase 2

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

2016

Completed Phase 2

~460

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

Cognitive Assessment

2011

Completed Phase 2

~1320

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,764 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 — Phase 2

Cancer Research Study Groups: Supportive care (SRS/SBRT, neurocognitive testing)

Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy Highlights & Side Effects. Trial Name: NCT03184038 — Phase 2

Stereotactic Body Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03184038 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are enrolled in this experiment?

"Verified, the details provided by clinicaltrials.gov demonstrate that this medical trial is actively enrolling patients since it was first advertised on February 21st 2017. Currently 90 participants are needed at 3 different locations nationwide."

Answered by AI

Are any vacancies available in this trial for prospective participants?

"According to clinicaltrials.gov, this medical research trial is actively recruiting participants; initial posting took place on February 21st 2017 with the most recent update occurring September 14th 2022."

Answered by AI

What hazards are associated with this medical treatment?

"The safety of this treatment is estimated to be a 2 due to the Phase 2 nature of the trial, which indicates that data exists in support of its security but none confirming effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery

2017. "Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03184038.

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