MeDex: No Perioperative Dexamethasone in Brain Metastases

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

Study Overview

• Status: Recruiting
• Conditions: Brain Metastases
• Intervention / Treatment: Other: Withholding perioperative Dexamethasone

Detailed Description

This is a single-arm trial, assessing the safety and efficacy of brain metastasis resection without perioperative Dex in a maximum of 35 patients screened and enrolled in our emergency room and clinics. Investigators will assess efficacy by noting presence of absence of lymphopenia. The patients will be followed until initiation of postoperative adjuvant cancer therapy for collection of primary and secondary endpoints.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: A Mistry, MD; Phone Number: 502-276-5030; Email: akshitkumar.mistry@louisville.edu
• Study Contact Backup: Name: M Kaufman, BSN; Phone Number: 502-852-1513; Email: mdkauf02@louisville.edu

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University of Louisville Hospital
      • Principal Investigator: Akshitkumar Mistry, MD
      • Contact: Mechelle Kaufman, BSN; Phone Number: 502-852-1513

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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. A condition that requires steroids
9. Stage 4 chronic kidney disease (GFR<30)
10. Pregnant or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Withholding perioperative dexamethasone; The safety and feasibility of withholding perioperative dexamethasone (Dex) in newly diagnosed cancer patients undergoing resection of brain metastases (BMs). The primary question is not comparative efficacy, but rather whether it is safe to forgo Dex in this patient population.	Other: Withholding perioperative Dexamethasone; Patients will not receive perioperative Dex before, during, and up to 3 weeks after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dexamethasone Rescue Need	Initiation of dexamethasone after enrollment up to 3 weeks after surgery.	4 weeks post operative (+-) 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunosuppression Assessment	Presence of absence of lymphopenia prior to adjuvant cancer therapy.	4 weeks post operative (+-) 2 weeks

Collaborators and Investigators

• Sponsor: University of Louisville
• Investigators: Principal Investigator: Akshitkumar Mistry, MD, University of Louisville

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: June 23, 2025
• First Submitted That Met QC Criteria: June 23, 2025
• First Posted (Actual): July 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 25.0244

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No