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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

Must not have

Patients with >4 brain metastases

Patients deemed medically unfit to undergo surgical resection of brain metastasis, such as those who are neurologically or hemodynamically unstable despite appropriate medical interventions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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I have more than 4 brain metastases.

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I am not a candidate for brain surgery due to my unstable health condition.

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I have a genetic condition or autoimmune disease like MS, lupus, or scleroderma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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

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

Primary study objectives

Maximum tolerated dose (MTD)

Secondary study objectives

Adverse events

Describe preliminary rates of rate of salvage treatment

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: 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.

0 / 6Eligibility criteria met