MeDex: No Perioperative Dexamethasone in Brain Metastases
Purpose
Perioperative treatment of newly diagnosed cancer patients with brain metastasis without dexamethasone (Dex).
Condition
- Brain Metastases
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- 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.
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Withholding perioperative dexamethasone |
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. |
|
Recruiting Locations
University of Louisville Hospital
Louisville, Kentucky 40202
Louisville, Kentucky 40202
Contact:
Mechelle Kaufman, BSN
502-852-1513
Mechelle Kaufman, BSN
502-852-1513
More Details
- Status
- Recruiting
- Sponsor
- University of Louisville
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. 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.