MeDex: No Perioperative Dexamethasone in Brain Metastases

NCT07044557 | Recruiting DMC

• 1 other identifier: 25.0244
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Brain Metastases

Outcome Measures

Primary Outcomes (1)

• Dexamethasone Rescue Need

  Initiation of dexamethasone after enrollment up to 3 weeks after surgery.

  4 weeks post operative (+-) 2 weeks

Secondary Outcomes (1)

• Immunosuppression Assessment

  4 weeks post operative (+-) 2 weeks

Study Arms (1)

Withholding perioperative dexamethasone

EXPERIMENTAL

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

Interventions

Withholding perioperative Dexamethasone OTHER

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

Withholding perioperative dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Akshitkumar Mistry, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

A Mistry, MD

CONTACT

502-276-5030; akshitkumar.mistry@louisville.edu

M Kaufman, BSN

CONTACT

502-852-1513; mdkauf02@louisville.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Assistant Professor

Model Details: Perioperative treatment of newly diagnosed cancer patients with brain metastasis without dexamethasone. We will conduct a single-arm trial, assessing the safety and efficacy of brain metastasis resection without perioperative Dex. We will assess efficacy by noting presence of absence of lymphopenia. The participants will be followed until initiation of postoperative adjuvant cancer therapy for collection of primary and secondary endpoints.

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: December 3, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)