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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4-5 years from first subject enrolled

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

Radiographic Local Control

Secondary outcome measures

Leptomeningeal disease

Pseudo-Progression

Radio-Necrosis

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 / 10Eligibility criteria met

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Who is running the clinical trial?

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Lead Sponsor

47 Previous Clinical Trials

13,059 Total Patients Enrolled

Elekta LimitedIndustry Sponsor

9 Previous Clinical Trials

8,808 Total Patients Enrolled

Rodney E Wegner, MDPrincipal InvestigatorAHN Radiation Oncology

1 Previous Clinical Trials

163 Total Patients Enrolled

Media Library

Pre-operative Stereotactic Radiosurgery (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT05341739 — N/A

Brain Metastases Research Study Groups: Pre-Operative Stereotactic Radiosurgery (SRS)

Brain Metastases Clinical Trial 2023: Pre-operative Stereotactic Radiosurgery Highlights & Side Effects. Trial Name: NCT05341739 — N/A

Pre-operative Stereotactic Radiosurgery (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05341739 — N/A

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 partaking in this clinical research?

"Affirmative. Clinical trials data reveals that this medical investigation, which was initially posted on December 14th 2021, is actively recruiting volunteers. Approximately 20 individuals are required to be enrolled from 1 centre."

Answered by AI

Does this clinical trial have any open positions for participants?

"Indeed, the information posted on clinicaltrials.gov confirms that this investigation is still in search of participants; it was initially made available on December 14th 2021 and has been updated as recently as April 18th 2022. Approximately 20 people are needed across a single medical centre to complete the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase II Study of Pre-Op SRS Followed by Surgical Resection for Brain Metastases

Rodney Wegner 2021. "A Phase II Study of Pre-Op SRS Followed by Surgical Resection for Brain Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05341739.

All > Brain Metastases