No perioperative dexamethasone for brain metastasis surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Louisville Hospital
  Louisville, Kentucky, United States Recruiting

Study contacts

• Principal investigator: Akshitkumar Mistry, MD — University of Louisville
• Study coordinator: A Mistry, MD
• Email: akshitkumar.mistry@louisville.edu
• Phone: 502-276-5030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.