MeDex: No Perioperative Dexamethasone in Brain Metastases

NCT ID: NCT07044557

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-03
• Study Completion Date: 2027-10-31

Brief Summary

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

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.

Conditions

Brain Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Withholding perioperative Dexamethasone

Intervention Type: OTHER

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

Interventions

Withholding perioperative Dexamethasone

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

Intervention Type: OTHER

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. A condition that requires steroids

9. Stage 4 chronic kidney disease (GFR<30)

10. Pregnant or breastfeeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Akshitkumar MIstry

M.D., Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Akshitkumar Mistry, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

University of Louisville Hospital

Louisville, Kentucky, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

A Mistry, MD

Role: CONTACT

akshitkumar.mistry@louisville.edu

502-276-5030

M Kaufman, BSN

Role: CONTACT

mdkauf02@louisville.edu

502-852-1513

Facility Contacts

Mechelle Kaufman, BSN

Role: primary

502-852-1513

Other Identifiers

25.0244

Identifier Type: -

Identifier Source: org_study_id