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Radiation Therapy
Stereotactic Radiosurgery vs Whole-Brain Radiotherapy for Brain Metastasis from Lung Cancer
Phase 3
Recruiting
Led By Vinai Gondi
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Brain metastases can be diagnosed synchronous to the initial diagnosis of small cell lung cancer or metachronous to the initial diagnosis and management of small cell lung cancer.
Ten or fewer brain metastases ≤ 3 cm in largest diameter and outside a 5-mm margin around either hippocampus must be visible on contrast-enhanced MRI performed ≤ 21 days prior to study entry
Must not have
Definitive leptomeningeal metastases
History of active malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial compares the effect of stereotactic radiosurgery to standard of care memantine and whole brain radiation therapy that avoids the hippocampus for the treatment of small cell lung cancer that has spread to the brain.
Who is the study for?
Adults with small cell lung cancer that has spread to the brain, who have not had prior brain radiotherapy or certain other cancers in the last 5 years. Participants must be able to undergo MRI scans, have a good performance status (able to carry out daily activities), and can't be pregnant. They should also not have severe medical conditions or history of allergic reactions to memantine.
What is being tested?
The trial is testing if stereotactic radiosurgery, which targets only tumor sites in the brain, is more effective at preserving memory and thinking than whole-brain radiation therapy avoiding the hippocampus combined with memantine hydrochloride.
What are the potential side effects?
Potential side effects include headaches, nausea, fatigue from radiation treatments; for memantine specifically - dizziness, confusion or constipation may occur. Side effects vary based on individual patient health and treatment specifics.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My small cell lung cancer has spread to my brain.
Select...
I have 10 or fewer small brain tumors, not near the memory center, confirmed by a recent MRI.
Select...
I am 18 years old or older.
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My tumor is smaller than 30 cubic centimeters.
Select...
My brain cancer was confirmed by an MRI with detailed requirements.
Select...
I have brain metastases that cause symptoms or are in critical brain areas.
Select...
My lung cancer is either new or has come back.
Select...
I am able to care for myself but may not be able to do active work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer has spread to the lining of my brain and spinal cord.
Select...
I have a history of cancer.
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I am currently taking medications like amantadine, ketamine, or dextromethorphan.
Select...
I still have seizures despite taking my seizure medication.
Select...
My brain scans show changes due to fluid buildup or other reasons that have altered the shape of my hippocampus.
Select...
I am scheduled for chemotherapy and radiation on the same day.
Select...
I have had radiation therapy to my brain.
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I have a history of a disease like multiple sclerosis.
Select...
I have had a condition where my lymphocytes multiply unusually.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time to Neurocognitive Failure
Secondary study objectives
Incidence of adverse events
Overall Survival
Perceived Difficulties in Cognition
+4 moreOther study objectives
Time delay to salvage WBRT or HA-WBRT in patients on the SRS arm
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 I (SRS)Experimental Treatment2 Interventions
Patients undergo SRS over 1 day (in some cases several days).
Group II: Arm II (HA-WBRT, memantine)Active Control3 Interventions
Patients also undergo HA-WBRT QD for 2 weeks in the absence of disease progression or unacceptable toxicity. Patients will also receive memantine PO QD or BID for up to 24 weeks in the absence of disease progression or unacceptable toxicity.
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
102,685 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,112,189 Total Patients Enrolled
Vinai GondiPrincipal InvestigatorNRG Oncology
2 Previous Clinical Trials
437 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My small cell lung cancer has spread to my brain.If more tests are done, they should follow the guidelines from Kaufmann et al., 2020.This section does not contain specific eligibility criteria.Your kidneys work well enough to clear at least 30 milliliters of creatinine from your blood per minute.I have 10 or fewer small brain tumors, not near the memory center, confirmed by a recent MRI.My cancer has spread to the lining of my brain and spinal cord.I am receiving immunotherapy alongside brain radiation.You have a serious, ongoing health problem.I had brain surgery at least 14 days before signing up.I have brain metastases but they don't cause symptoms and are not in critical brain areas.I have a history of cancer.I am 18 years old or older.I am receiving immunotherapy alongside brain radiation.Women who can have babies must have a negative pregnancy test within 14 days before joining the study.My tumor is smaller than 30 cubic centimeters.I am currently taking medications like amantadine, ketamine, or dextromethorphan.My brain cancer was confirmed by an MRI with detailed requirements.I completed specific brain function tests within the last 21 days.I have brain metastases that cause symptoms or are in critical brain areas.I still have seizures despite taking my seizure medication.You cannot have a magnetic resonance imaging (MRI) scan for medical reasons.My brain scans show changes due to fluid buildup or other reasons that have altered the shape of my hippocampus.I am scheduled for chemotherapy and radiation on the same day.You had an allergic reaction to memantine before.My small cell lung cancer was diagnosed or reconfirmed within the last 5 years.I have had radiation therapy to my brain.I have a history of a disease like multiple sclerosis.My lung cancer is either new or has come back.I haven't had any cancer, except for skin cancer, in the last 5 years.I have had a condition where my lymphocytes multiply unusually.I am able to care for myself but may not be able to do active work.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (SRS)
- Group 2: Arm II (HA-WBRT, memantine)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.