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Radiation Therapy

Stereotactic Radiosurgery for Brain Metastases

N/A
Waitlist Available
Led By Steve Burton, MD
Research Sponsored by Steven Burton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A life expectancy of at least 12 weeks with a Karnofsky performance status of at least 70
No prior radiotherapy to the brain
Must not have
Four or more newly-diagnosed lesions
Symptomatic patients in need of surgery to the 'target' lesion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether fractionated stereotactic radiosurgery (FSRS) is a feasible treatment option for people with no prior whole brain radiation.

Who is the study for?
This trial is for adults with brain metastases who have not had whole brain radiation. They should be expected to live at least 12 weeks, be fairly active (Karnofsky score ≥70), and have up to 3 measurable brain lesions, one between 3-5cm. Prior chemotherapy is okay, but no prior radiotherapy or surgery on the target lesion(s). Pregnant or breastfeeding individuals are excluded.
What is being tested?
The study tests fractionated stereotactic radiosurgery (FSRS) which divides the total radiation dose into smaller treatments for large brain metastases. The goal is to see if FSRS can treat larger tumors that typically wouldn't be candidates for single-dose radiosurgery.
What are the potential side effects?
Potential side effects of FSRS include fatigue, headaches, hair loss at treatment site, nausea, swelling in the treated area leading to increased pressure within the skull and potential neurological issues like difficulty speaking or weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am expected to live at least 12 weeks and can care for myself with some assistance.
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I have not had radiation treatment to my brain.
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My primary cancer is not in the brain.
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I have a tumor between 3cm and 5cm suitable for targeted radiation therapy.
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I have 3 or fewer distinct brain lesions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have four or more new lesions.
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I need surgery for my main cancer lesion because it's causing symptoms.
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I have had surgery to remove a specific tumor.
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I have had whole brain radiation therapy before.
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I have a primary brain tumor.
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My cancer is either lymphoma, leukemia, multiple myeloma, or a germ cell tumor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
Local control of disease
Adrenal gland hypofunction

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: Fractionated Stereotactic RadiosurgeryExperimental Treatment1 Intervention
24 to 36 Gy in 3 fractions (8-12 Gy/fx).

Find a Location

Who is running the clinical trial?

Steven BurtonLead Sponsor
3 Previous Clinical Trials
203 Total Patients Enrolled
Steve Burton, MDPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
173 Total Patients Enrolled

Media Library

Fractionated Stereotactic Radiosurgery (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02054689 — N/A
Brain metastases Research Study Groups: Fractionated Stereotactic Radiosurgery
Brain metastases Clinical Trial 2023: Fractionated Stereotactic Radiosurgery Highlights & Side Effects. Trial Name: NCT02054689 — N/A
Fractionated Stereotactic Radiosurgery (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02054689 — N/A
~2 spots leftby Dec 2025
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