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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
Must not have
More than one brain metastasis planned for resection
Primary histology of germ cell tumor, small cell carcinoma, or lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

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.
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.
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
Select...
My brain metastases are not near the optic nerve or in the brainstem.
Select...
My untreated cancer spots are smaller than 4.0 cm.
Select...
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am scheduled for surgery to remove more than one brain tumor.
Select...
My cancer is either a germ cell tumor, small cell carcinoma, or lymphoma.
Select...
My cancer has spread to the lining of my brain and spinal cord.
Select...
I don't have health issues that make surgery or anesthesia too risky for me.
Select...
I have had radiation therapy to my brain.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to Composite Adverse Endpoint (CAE)
Secondary study objectives
Change in MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
Change in cognitive function
Frequency of adverse events (AEs)
+5 more
Other study objectives
Type of surgical resection

Awards & Highlights

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

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
2021
Completed Phase 2
~440

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
238 Previous Clinical Trials
102,859 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,927 Previous Clinical Trials
41,017,796 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
~118 spots leftby Mar 2027
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