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Surgery and Radiation vs. Radiation Alone for Brain Cancer

Phase 3
Recruiting
Led By Stuart H Burri
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All brain metastases must be located > 5 mm from the optic chiasm and outside the brainstem
Maximum diameter of the lesions not to be resected must measure < 4.0 cm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study Summary

This trialcompares two treatments to help stop cancer spread to the brain: surgery w/ radiation therapy or radiation therapy alone. Radiation is targeted to cancer cells while avoiding healthy brain tissue.

Who is the study for?
This trial is for adults with 1-4 brain metastases, one needing surgery. Participants must have a lesion larger than 2cm but smaller than 5cm, not near the optic chiasm or in the brainstem, and be able to tolerate surgery and radiosurgery. They should agree to use contraception and not have had certain cancers or prior cranial radiotherapy.Check my eligibility
What is being tested?
The study compares adding stereotactic radiosurgery (high-dose radiation targeting only cancer areas) before or after surgical removal of brain tumors. It aims to see which sequence is more effective at controlling tumor growth and reducing symptoms.See study design
What are the potential side effects?
Potential side effects include those typical of surgery such as infection risk, bleeding, reaction to anesthesia; and from radiosurgery like headaches, nausea, hair loss at treatment site, fatigue, swelling around the treated area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My brain metastases are not near the optic nerve or in the brainstem.
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My untreated cancer spots are smaller than 4.0 cm.
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The tumor to be removed is between 2.0 cm and 5.0 cm in size.
Select...
I am medically fit for surgery and stereotactic radiosurgery (SRS).
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years 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 to Composite Adverse Endpoint (CAE)
Secondary outcome measures
Change in MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
Change in cognitive function
Frequency of adverse events (AEs)
+5 more
Other outcome measures
Type of surgical resection

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (stereotactic radiosurgery, surgery)Experimental Treatment4 Interventions
Within 7 days before surgery, patients undergo stereotactic radiosurgery for 1 fraction. Patients undergo surgery per standard of care.
Group II: Arm I (surgery, stereotactic radiosurgery)Active Control4 Interventions
Patients undergo surgery per standard of care. Within 10-30 days after surgery, patients undergo stereotactic radiosurgery for 1 fraction.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery
2016
Completed Phase 2
~490

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
232 Previous Clinical Trials
100,542 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,719 Previous Clinical Trials
40,963,322 Total Patients Enrolled
Stuart H BurriPrincipal InvestigatorNRG Oncology

Media Library

Brain Surgery Clinical Trial Eligibility Overview. Trial Name: NCT05438212 — Phase 3
Brain Metastasis Research Study Groups: Arm II (stereotactic radiosurgery, surgery), Arm I (surgery, stereotactic radiosurgery)
Brain Metastasis Clinical Trial 2023: Brain Surgery Highlights & Side Effects. Trial Name: NCT05438212 — Phase 3
Brain Surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT05438212 — Phase 3
~144 spots leftby Mar 2027
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