MeDex: No Perioperative Dexamethasone in Brain Metastases
University of Louisville
Summary
Perioperative treatment of newly diagnosed cancer patients with brain metastasis without dexamethasone (Dex).
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 (sur…
Interventions
- OtherWithholding perioperative Dexamethasone
Patients will not receive perioperative Dex before, during, and up to 3 weeks after surgery.
Location
- University of Louisville HospitalLouisville, Kentucky