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Recruiting NCT07044557

MeDex: No Perioperative Dexamethasone in Brain Metastases

Trial Parameters

Condition Brain Metastases
Sponsor University of Louisville
Study Type INTERVENTIONAL
Phase N/A
Enrollment 35
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-12-03
Completion 2027-10
Interventions
Withholding perioperative Dexamethasone

Brief Summary

Perioperative treatment of newly diagnosed cancer patients with brain metastasis without dexamethasone (Dex).

Eligibility Criteria

Inclusion Criteria: 1. New brain tumor(s) on imaging 2. Visceral mass(es) suspicious or confirmed 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.

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