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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

Must not have

A brain metastasis that is located within 2 mm of the optic chiasm

Any prior cranial radiotherapy targeting the index lesion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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My brain cancer is near the optic nerve.

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I have had radiation therapy on my brain for a tumor.

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I am not pregnant or breastfeeding.

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I have had whole brain radiation in the last 3 months.

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I have a germ cell tumor, primary brain tumor, or lymphoma.

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My brain cancer symptoms cannot be managed with steroids.

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I am not taking strong cancer drugs within a week before or with focused radiation.

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I am considered unfit for brain surgery due to other health issues.

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My main cancer lesion is in my brainstem.

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I can't or won't be able to attend all required follow-up visits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Time from Start of fSRS until Progression

Secondary study objectives

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

Other study objectives

Local Control Rate

Rate of Leptomeningeal Disease (LMD)

Rate of distant brain recurrence (DBR)

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: 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 / 15Eligibility criteria met