MeDex: No Perioperative Dexamethasone in Brain Metastases
ConditionBrain Metastases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Louisville
About this trial
Perioperative treatment of newly diagnosed cancer patients with brain metastasis without dexamethasone (Dex).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
New brain tumor(s) on imaging
Visceral mass(es) suspicious or confirmed for neoplasm
No contraindications for craniotomy
Age ≥ 18 years
Disqualifiers
Presence of BMs not eligible for resection that are each > 2 cm in any one dimension
>4 BMs not eligible for resection that are each 2 cm in any one dimension
Treatment with laser interstitial thermal therapy (LITT)
High concern for primary CNS lymphoma
Trial design
Design model
Single group
Treatments tested in this trial
Withholding perioperative Dexamethasone
Other interventionPatients will not receive perioperative Dex before, during, and up to 3 weeks after surgery.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Withholding perioperative dexamethasoneExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dexamethasone Rescue Need
Initiation of dexamethasone after enrollment up to 3 weeks after surgery.
Time frame
4 weeks post operative (+-) 2 weeksSecondary outcomes
1
Immunosuppression Assessment
Presence of absence of lymphopenia prior to adjuvant cancer therapy.
Time frame
4 weeks post operative (+-) 2 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov