MeDex: No Perioperative Dexamethasone in Brain Metastases

University of Louisville (UOFL)

Status: Enrolling

Conditions: Brain Metastases

Treatments: Other: Withholding perioperative Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT07044557

25.0244

Details and patient eligibility

About

Perioperative treatment of newly diagnosed cancer patients with brain metastasis without dexamethasone (Dex).

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Withholding perioperative dexamethasone

Experimental group

Description:

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.

Treatment:

Other: Withholding perioperative Dexamethasone