MeDex: No Perioperative Dexamethasone in Brain Metastases

Launched by UNIVERSITY OF LOUISVILLE · Jun 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new approach for people who have recently been diagnosed with brain metastases, which means cancer that has spread to the brain from another part of the body. Specifically, the study is looking at the effects of not using a common steroid medication called dexamethasone around the time of brain surgery. Dexamethasone is often given to reduce swelling in the brain, but this trial wants to see if it’s safe and effective to avoid using it during surgery.

To join the study, participants need to be adults who have a new brain tumor seen on scans and a suspicious mass in another part of the body, like the lungs, that might be the original cancer. They should be well enough to have brain surgery planned to remove most of the tumor and not have used steroids recently or have conditions that require steroid treatment. People with certain types of cancer (like small cell lung cancer) or severe kidney problems cannot join. If eligible and participating, patients will undergo brain surgery without receiving dexamethasone before, during, or after the operation, and the researchers will monitor how this affects their recovery and outcomes. This study is not yet open for enrollment but aims to improve care for people with brain metastases by exploring alternatives to standard steroid use.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. New brain tumor(s) on imaging
• • 2. Visceral mass(es) suspicious for neoplasm
• • a. Patients with lung mass suspicious for primary lung cancer and no prior diagnosis must undergo biopsy of the lung mass prior to resection of brain metastasis(es) to exclude histology (i.e., small cell lung carcinoma) that would not benefit from resection
• • 3. No contraindications for craniotomy
• • 4. Age ≥ 18 years
• • 5. ECOG performance status ≤ 2 (i.e., ambulatory \> 50% of waking hours)
• • 6. Midline shift on MRI ≤ 10 mm
• • 7. Craniotomy planned to resect \>75% of the enhancing mass (surgeon's judgment)
• Exclusion Criteria:
• • 1. Presence of BMs not eligible for resection that are each \> 2 cm in any one dimension
• • 2. \>4 BMs not eligible for resection that are each 2 cm in any one dimension
• • 3. Treatment with laser interstitial thermal therapy (LITT)
• • 4. High concern for primary CNS lymphoma
• • 5. Diagnosis of small cell lung carcinoma
• • 6. Any receipt of Dex
• • 7. Steroid use in the past month
• • 8. A condition that requires steroids
• • 9. Stage 4 chronic kidney disease (GFR\<30)
• • 10. Pregnant or breastfeeding