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Stereotactic Radiosurgery vs Whole-Brain Radiotherapy for Brain Metastasis from Lung Cancer
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Arm I (SRS)
- Group 2: Arm II (HA-WBRT, memantine)
- 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.
- 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.
Frequently Asked Questions
What are other examples of research using Stereotactic Radiosurgery?
"First observed in 1997 at Vanderbilt University's Autonomic Dysfunction Center, Stereotactic Radiosurgery has been the focus of 122 clinical trials. Out of these, 27 are still active. Maryland's Easton location has a high concentration of these ongoing studies."
Has Stereotactic Radiosurgery been cleared by the FDA?
"There is some efficacy data and multiple rounds of safety data, so our team has rated the safety of Stereotactic Radiosurgery as a 3."
Are we currently enrolling patients for this experiment?
"Yes, this information is accurate. The trial was posted on 24 March 2021 and was updated on 8 April 2022."
How many individuals are being monitored for this research?
"That is correct. The clinical trial is recruiting at 82 locations and is looking for a total of 200 participants. The original posting was on 2021-03-24, with the most recent update on 2022-04-08."
Do a lot of hospitals in Canada offer this treatment?
"So far, 82 patients have enrolled at this clinical trial's various locations, which include the University of Maryland Shore Medical Center at Easton in Easton, Saint Mary Mercy Hospital in Livonia, and Missouri Baptist Outpatient Center-Sunset Hills in Sunset Hills."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
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