MeDex: No Perioperative Dexamethasone in Brain Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Withholding perioperative Dexamethasone.
- Who it may be relevant to
- Registry conditions: Brain Metastases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Withholding perioperative Dexamethasone
Patients will not receive perioperative Dex before, during, and up to 3 weeks after surgery.
Primary outcome measures
- Dexamethasone Rescue Need [Time frame: 4 weeks post operative (+-) 2 weeks]
Secondary outcome measures (1)
- Immunosuppression Assessment [Time frame: 4 weeks post operative (+-) 2 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Louisville Hospital — Louisville
Identifiers
NCT: NCT07044557 · 25.0244