MeDex: No Perioperative Dexamethasone in Brain Metastases | NCT07044557

Studies
MeDex: No Perioperative Dexamethasone in Brain Metastases

NCT07044557

Sponsor

University of Louisville

Status

Recruiting

Last Update Posted

May 29, 2026Actual

Enrollment

35Estimated

Phase

Not Applicable

Conditions

Brain Metastases

Interventions

Withholding perioperative Dexamethasone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2026Estimated

Primary Completion Date

Oct 2027Estimated

Completion Date

Oct 2027Estimated

First Submitted Date

Jun 23, 2025

First Submission Date that Met QC Criteria

Jun 23, 2025

First Posted Date

Jul 1, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2026

Last Update Posted Date

May 29, 2026Actual

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Withholding perioperative dexamethasone	Experimental	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.	Other: Withholding perioperative Dexamethasone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Withholding perioperative Dexamethasone	Other	Patients will not receive perioperative Dex before, during, and up to 3 weeks after surgery.	Withholding perioperative dexamethasone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dexamethasone Rescue Need	Initiation of dexamethasone after enrollment up to 3 weeks after surgery.	4 weeks post operative (+-) 2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Immunosuppression Assessment	Presence of absence of lymphopenia prior to adjuvant cancer therapy.	4 weeks post operative (+-) 2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

New brain tumor(s) on imaging
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
No contraindications for craniotomy
Age ≥ 18 years
ECOG performance status ≤ 2 (i.e., ambulatory > 50% of waking hours)
Midline shift on MRI ≤ 10 mm
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
>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
Diagnosis of small cell lung carcinoma
Any receipt of Dex
Steroid use in the past month
A condition that requires steroids
Stage 4 chronic kidney disease (GFR<30)
Pregnant or breastfeeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
A Mistry, MD	Contact	502-276-5030		akshitkumar.mistry@louisville.edu
M Kaufman, BSN	Contact	502-852-1513		mdkauf02@louisville.edu

Overall Officials

Name	Affiliation	Role
Akshitkumar Mistry, MD	University of Louisville	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Louisville Hospital	Recruiting	Louisville	Kentucky	40202	United States

ID	Term
D001932	Brain Neoplasms

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

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.