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Radiation

Radiation Therapy for Brain Metastasis

Phase 3
Recruiting
Led By Rupesh R Kotecha
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis-specific graded prognostic assessment ≥ 1.5
No more than 2 lesions planned for resection if clinically indicated
Must not have
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
History of leptomeningeal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial compares two types of radiation therapy for treating cancer that has spread to the brain. One type, called fractionated stereotactic radiosurgery (FSRS), delivers a high dose of radiation over

Who is the study for?
This trial is for patients with certain cancers (like melanoma, lung, breast, kidney cancer) that have spread to the brain. Participants must be eligible for high-energy x-ray treatments and should not have conditions that exclude them from radiation therapy.
What is being tested?
The study compares two types of radiation therapy: Fractionated Stereotactic Radiation Therapy (FSRS), given over three sessions, versus a single-session Stereotactic Radiosurgery (SRS). The goal is to see if FSRS is more effective in treating brain tumors from cancer spread.
What are the potential side effects?
Radiation therapies like FSRS and SRS can cause headaches, fatigue, hair loss at treatment site, skin irritation or redness, nausea and short-term memory issues. Long-term side effects may include changes in brain function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer prognosis score is 1.5 or higher.
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I am planning to have surgery for up to 2 cancer lesions.
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I am 18 years old or older.
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I can care for myself but may need occasional help.
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My heart condition does not severely limit my physical activity.
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I do not have any infections needing IV antibiotics.
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My liver functions well, without jaundice or blood clotting issues.
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I have 1 to 8 brain tumors detected by a recent MRI.
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I have a tumor between 1.0 cm and 3.0 cm that can be studied.
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I do not have cancer that has spread to the lining of my brain and spinal cord.
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I don't have severe lung problems that would stop me from receiving study treatment.
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My brain cancer is not in the brainstem and is away from my optic nerves.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have liver problems causing jaundice or blood clotting issues.
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I have had leptomeningeal disease.
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I have had radiation therapy to my brain.
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I am currently being treated for an infection with IV antibiotics.
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I do not have a recent severe lung problem that would stop me from receiving the study treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Incidence of adverse events (AEs)
Intracranial progression-free survival (IPFS)
Overall survival
+2 more
Other study objectives
Time to local failure

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ARM II (FSRS)Experimental Treatment3 Interventions
Patients undergo FSRS over 30-90 minutes for 3 fractions on study. Additionally, patients undergo CT and MRI on study.
Group II: ARM I (SRS)Active Control3 Interventions
Patients undergo SRS over 30-90 minutes for 1 fraction on study. Additionally, patients undergo CT and MRI on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2740
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,927 Previous Clinical Trials
41,017,769 Total Patients Enrolled
NRG OncologyLead Sponsor
238 Previous Clinical Trials
102,826 Total Patients Enrolled
Rupesh R KotechaPrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials
24 Total Patients Enrolled
~179 spots leftby Jun 2028
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