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Radiation

Pre-Op SRS Before Surgery for Brain Metastases

N/A

Recruiting

Led By Rodney E Wegner, MD

Research Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Eligibility Criteria Checklist

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

Must have

Solid tumor brain metastases

Brain MRI within 1 month of initiation of brain SRS

Must not have

Karnofsky Performance Status (KPS) less than <70

Prior WBRT or SRS to the index lesion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4-5 years from first subject enrolled

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if performing stereotactic radiosurgery (SRS) before surgical resection of a brain metastasis improves local control and lowers the risk of radionecrosis and leptomeningeal disease.

Who is the study for?

This trial is for adults with solid tumor brain metastases who can consent to treatment, have a Karnofsky Performance Status of ≥70 (meaning they are able to care for themselves), and agree to use contraception. They must be planning surgery for at least one brain metastasis smaller than 5 cm. Those with serious medical or psychiatric illnesses, prior whole-brain radiation, or pregnant women cannot participate.

What is being tested?

The study tests if performing stereotactic radiosurgery (SRS) before surgical removal of the brain tumor improves chances of complete removal without recurrence and reduces risks like tissue breakdown at the tumor site and leptomeningeal disease development.

What are the potential side effects?

Potential side effects include complications from radiation such as headaches, nausea, hair loss near treated areas, fatigue, skin irritation at the treatment site, swelling in the brain which might cause various neurological symptoms depending on location.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has spread to my brain.

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I had a brain MRI less than a month before starting brain SRS.

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I am 18 years old or older.

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I have had radiation therapy for brain cancer before.

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I am mostly able to care for myself.

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I have not had radiation therapy to my brain.

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My cancer diagnosis is confirmed by tissue or cell analysis.

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I have several brain tumors and will undergo surgery for each.

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The largest tumor to be removed from my brain is smaller than 5 cm.

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I have agreed to surgery for brain metastasis.

Exclusion Criteria

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

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I need assistance with my daily activities.

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I have had whole brain radiation therapy or stereotactic radiosurgery on the main tumor.

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My brain tumor is 5 cm or smaller.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-5 years from first subject enrolled

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4-5 years from first subject enrolled

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-5 years from first subject enrolled for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Radiographic Local Control

Secondary study objectives

Leptomeningeal disease

Pseudo-Progression

Radio-Necrosis

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: Pre-Operative Stereotactic Radiosurgery (SRS)Experimental Treatment1 Intervention

Subjects are treated using the standard of care SRS to a total dose of 24-27 Gray (Gy) in 3 fractions with a once daily fractionation or every other day at treating physician discretion. The preferred dose will be 27 Gy, with ability to drop dose down to 24 Gy if normal tissue constraints cannot be met. It should be noted, that while the dosing remains within standard of care, the timing of the radiation (pre-operative) is still not considered standard of care but is supported by emerging data as described in the study background. Additional metastatic lesions may be treated using SRS according to institutional practices. The radiation dose prescribed to the non-index lesions is at the discretion of the treating physicians. Surgical resection will be performed within 2 weeks of completion of SRS.

0 / 13Eligibility criteria met