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Radiation Therapy

Preoperative Stereotactic Radiosurgery for Brain Metastases

Phase 2

Recruiting

Led By Michael Yu, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Karnofsky Performance Status (KPS) >/=60

Histologically confirmed solid tumor malignancy other than lymphoma, or germ cell tumor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12 months

Awards & highlights

Study Summary

This trial will compare two cancer treatments to see which one is more effective.

Who is the study for?

This trial is for adults with certain solid tumor cancers that have spread to the brain, and are expected to live at least 3 more months. They must have one or more brain tumors suitable for surgery and not previously treated with specific radiosurgery. Participants should be able to undergo MRI scans, not be pregnant or breastfeeding, and willing to use effective contraception.Check my eligibility

What is being tested?

The study tests if pre-operative hypofractionated stereotactic radiosurgery (a type of focused radiation therapy) followed by surgery can extend the time before a brain tumor starts growing again compared to current treatments.See study design

What are the potential side effects?

Potential side effects may include headaches, nausea, fatigue, hair loss at treatment site, skin irritation around the area of radiation, swelling in the brain which might cause 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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I can care for myself but may need occasional help.

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My cancer is not lymphoma or a germ cell tumor, but another type of solid tumor.

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My smaller cancer spots are all 4 cm or less and don't need surgery.

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My brain cancer symptoms are either non-existent or well-managed with steroids.

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I have a brain tumor between 10mm and 60mm, suitable for surgery, not treated with SRS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 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

Time from Start of fSRS until Progression

Secondary outcome measures

Time from Start of fSRS until First Development of Leptomeningeal Disease or Death

Other outcome measures

Local Control Rate

Rate of Leptomeningeal Disease (LMD)

Rate of distant brain recurrence (DBR)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Hypofractionated Stereotactic Radiosurgery prior to resectionExperimental Treatment1 Intervention

Participants will be given hypofractionated stereotactic radiosurgery (fSRS) in 9 Gray Units (Gy) per fraction x 3 consecutive daily fractions (27 Gy total) to the index metastasis that will be resected on Days 1-3 (3 consecutive days). If there are additional non index brain metastasis, they will be treated with standard stereotactic radiosurgery at the time of fSRS. Participants will then undergo stereotactic craniotomy for surgical resection of the index metastasis within 5 days following completion of fSRS.

0 / 5Eligibility criteria met

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Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,435 Total Patients Enrolled

Michael Yu, MDPrincipal InvestigatorMoffitt Cancer Center

4 Previous Clinical Trials

49 Total Patients Enrolled

Media Library

$Hypofractionated Stereotactic Radiosurgery (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05267587 — Phase 2$

$Brain Tumor Research Study Groups: Hypofractionated Stereotactic Radiosurgery prior to resection$

$Brain Tumor Clinical Trial 2023: Hypofractionated Stereotactic Radiosurgery Highlights & Side Effects. Trial Name: NCT05267587 — Phase 2$

$Hypofractionated Stereotactic Radiosurgery (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05267587 — Phase 2$

Frequently Asked Questions

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

How many people are receiving care as part of this investigation?

"The information available on clinicaltrials.gov suggests that this study is still recruiting patients. The trial was originally posted on February 22nd, 2022 and edited two days ago on the 24th. They are looking for 60 individuals total from a single location."

Answered by AI

Are there any open positions for volunteers in this clinical trial?

"The trial is currently ongoing, with the latest update having been posted on 2/24/2022. This information can be found clinicaltrials.gov, where the trial was originally posted on 2/22/2022."

Answered by AI

Has Hypofractionated Stereotactic Radiosurgery received government sanctioning from the FDA?

"Given that this is a Phase 2 trial, meaning there has only been evidence supporting safety and no efficacy, our team Power rates the Hypofractionated Stereotactic Radiosurgery as a 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Preop fSRS for Resectable Brain Metastases

2022. "Preop fSRS for Resectable Brain Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05267587.

All > Brain Metastases