Clinical trial · Interventional
MeDex: No Perioperative Dexamethasone in Brain Metastases
NCT07044557CI-TRIAL-00112920recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Perioperative treatment of newly diagnosed cancer patients with brain metastasis without dexamethasone (Dex).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Withholding perioperative Dexamethasone | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Withholding perioperative dexamethasone
- 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.
- interventionNames
- Other: Withholding perioperative Dexamethasone
Primary outcomes (1)
- measure
- Dexamethasone Rescue Need
- timeFrame
- 4 weeks post operative (+-) 2 weeks
- description
- Initiation of dexamethasone after enrollment up to 3 weeks after surgery.
Secondary outcomes (1)
- measure
- Immunosuppression Assessment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.