RecruitingNot ApplicableNCT07044557

MeDex: No Perioperative Dexamethasone in Brain Metastases

Sponsor

University of Louisville

Enrollment

35 participants

Start Date

Dec 3, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

New brain tumor(s) on imaging
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
No contraindications for craniotomy
Age ≥ 18 years
ECOG performance status ≤ 2 (i.e., ambulatory \> 50% of waking hours)
Midline shift on MRI ≤ 10 mm
Craniotomy planned to resect \>75% of the enhancing mass (surgeon's judgment)

Presence of BMs not eligible for resection that are each \> 2 cm in any one dimension
\>4 BMs not eligible for resection that are each 2 cm in any one dimension
Treatment with laser interstitial thermal therapy (LITT)
High concern for primary CNS lymphoma
Diagnosis of small cell lung carcinoma
Any receipt of Dex
Steroid use in the past month
A condition that requires steroids
Stage 4 chronic kidney disease (GFR\<30)
Pregnant or breastfeeding

OTHERWithholding perioperative Dexamethasone

Patients will not receive perioperative Dex before, during, and up to 3 weeks after surgery.

University of Louisville Hospital

Louisville, Kentucky, United States

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NCT07044557