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Brain tumor patients may skip routine steroids during surgery

NCT ID NCT07044557

Symptom relief Sponsor: University of Louisville Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether it is safe to avoid giving the steroid dexamethasone before, during, and for three weeks after brain metastasis surgery. The goal is to see if patients can avoid the side effects of steroids without needing extra rescue doses. The trial will enroll 35 adults with newly found brain tumors and a suspected or confirmed cancer elsewhere in the body.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
withholding dexamethasone (steroid)
What this could lead to
If successful, this could show that many patients with brain metastases can safely avoid routine steroids around surgery, reducing side effects.
What could go wrong
This is a very small, early-phase study (35 people) with no control group. It only tests whether steroids can be withheld, not whether this improves long-term outcomes. Some patients may still need rescue steroids.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 35 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

brain cancer metastatic malignant neoplasm in the brain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain metastases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Louisville Hospital

    RECRUITING

    Louisville, Kentucky, 40202, United States

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