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Radiation Therapy

Pre-Surgery Radiosurgery for Brain Tumor

Phase < 1
Waitlist Available
Led By Stephen Shiao, MD, PhD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non-acute KPS ≥ 60%
Patients with prior histopathological diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial will study if giving radiation to a brain tumor before neurosurgery will help keep brain tissue healthy and potentially eliminate the need for radiation after surgery.

Who is the study for?
This trial is for adults with a life expectancy of at least 3 months who have certain types of cancer, excluding small cell lung cancer, lymphoma, and germ cell cancers. They must have one brain tumor suitable for surgery and radiosurgery, be able to follow study requirements, not be pregnant if applicable, and have a performance status indicating they are mostly independent.Check my eligibility
What is being tested?
The trial tests whether giving stereotactic radiosurgery (a type of focused radiation therapy) before surgically removing brain tumors can improve outcomes and reduce the need for additional treatments. It also aims to determine the best dose of radiation by monitoring effectiveness and side effects.See study design
What are the potential side effects?
Potential side effects include damage to healthy brain tissue leading to neurological problems, fatigue from radiation therapy, skin irritation at the treatment site, headaches or swelling due to changes in the tumor area after treatment.

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 assistance.
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I have a history of cancer, but it was not small cell lung cancer, lymphoma, or germ cell cancer.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD)
Secondary outcome measures
Adverse events
Describe preliminary rates of image-complete resection
Describe preliminary rates of intracranial control
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Neoadjuvant stereotactic radiosurgeryExperimental Treatment2 Interventions
Stereotactic radiosurgery will be performed prior to neurosurgical resection of the indexed brain metastasis. The dose of radiation to be administered to the indexed lesion will be established as a function of tumor size.

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
499 Previous Clinical Trials
164,832 Total Patients Enrolled
Stephen Shiao, MD, PhDPrincipal Investigator - Cedars-Sinai Medical Center
Cedars-Sinai Medical Center, Westside Radiation Oncology Medical Group Inc
Yale University School Of Medicine (Medical School)
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Neoadjuvant Stereotactic Radiosurgery (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03163368 — Phase < 1
Brain Tumor Research Study Groups: Neoadjuvant stereotactic radiosurgery
Brain Tumor Clinical Trial 2023: Neoadjuvant Stereotactic Radiosurgery Highlights & Side Effects. Trial Name: NCT03163368 — Phase < 1
Neoadjuvant Stereotactic Radiosurgery (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03163368 — Phase < 1

Frequently Asked Questions

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

Is this clinical trial still enrolling patients?

"That is correct, the online clinicaltrials.gov registry shows that this study is actively recruiting patients. The listing indicates that the trial began on May 9th, 2017 and was most recently updated on August 4th, 2022. They are looking for a total of 25 patients across 1 site."

Answered by AI

How many individuals are signed up to help with this research?

"Yes, this trial is still looking for patients, according to the most recent data from clinicaltrials.gov. The posting date was May 9th, 2017, and the trial is taking place at a single location. They need 25 total participants."

Answered by AI
~3 spots leftby Apr 2025