MeDex: No Perioperative Dexamethasone in Brain Metastases

Not Applicable

Not yet recruiting

• Conditions: Brain Metastases

• Registration Number: NCT07044557
• Lead Sponsor: University of Louisville

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. We 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 Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-23
• Study First Submitted QC: 2025-06-23
• Last Update Submitted: 2025-06-23
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01
• Study Start: 2025-10-01
• Primary Completion: 2027-10
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. New brain tumor(s) on imaging

2. Visceral mass(es) suspicious 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Dexamethasone Rescue Need	4 weeks post operative (+-) 2 weeks	Initiation of dexamethasone after enrollment up to 3 weeks after surgery.

Secondary Outcome Measures

Name	Time	Method
Immunosuppression Assessment	4 weeks post operative (+-) 2 weeks	Presence of absence of lymphopenia prior to adjuvant cancer therapy.