No perioperative dexamethasone for brain metastasis surgery

MeDex: No Perioperative Dexamethasone in Brain Metastases

This trial will try skipping perioperative dexamethasone in adults having surgery for newly diagnosed brain metastases to see if it is safe and reduces lymphopenia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Louisville (Academic / other)
• Locations: 1 site (Louisville, Kentucky)
• Trial ID: NCT07044557 on ClinicalTrials.gov

What this trial studies

This single-arm study will enroll up to 35 adults with newly diagnosed brain metastases who are planned for craniotomy. Participants will not receive perioperative dexamethasone and will be followed from surgery until initiation of postoperative adjuvant cancer therapy. Investigators will record safety outcomes and primarily note presence or absence of lymphopenia as the efficacy measure. Patients are screened and enrolled from the emergency room and clinics at a single center and follow-up includes lab monitoring until adjuvant therapy begins.

Who should consider this trial

Good fit: Adults (≥18) with newly identified brain metastases who are ambulatory (ECOG ≤2), have midline shift ≤10 mm, and are planned for craniotomy to resect >75% of the enhancing lesion are ideal candidates.

Not a fit: Patients with unresectable or numerous large brain metastases, small cell lung carcinoma, recent or ongoing steroid use, or other contraindications to craniotomy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could reduce perioperative lymphopenia and avoid steroid-related side effects, potentially improving patients' immune response to subsequent cancer treatments.

How similar studies have performed: This specific no-steroid perioperative approach is relatively novel with limited prospective data, though prior observational work has linked perioperative steroids to lymphopenia and worse immune markers.

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

Where this trial is running

Louisville, Kentucky

• University of Louisville Hospital — Louisville, Kentucky, United States (Recruiting)

Study contacts

• Principal investigator: Akshitkumar Mistry, MD — University of Louisville
• Study coordinator: A Mistry, MD

Conditions Brain Metastases