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NCT05139043 · ClinicalTrials.gov registry record · Phase 2
Low Dose Versus Standard Dose Dexamethasone for Reduction of Swelling in Patients with Primary or Metastatic Brain Tumors
A Phase 2 study of Metastatic Malignant Neoplasm in the Brain and Malignant Brain Neoplasm, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT05139043: Active Phase 2 study of Metastatic Malignant Neoplasm in the Brain and Malignant Brain Neoplasm, sponsored by City of Hope Medical Center.
NCT05139043 is a Phase 2 study of Metastatic Malignant Neoplasm in the Brain and Malignant Brain Neoplasm that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 26 participants, below the 87-participant average among 43 other Metastatic Malignant Neoplasm in the Brain trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05139043, a Phase 2 study of Metastatic Malignant Neoplasm in the Brain and Malignant Brain Neoplasm, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies whether low dose dexamethasone works as well as standard dose dexamethasone to reduce brain swelling after brain surgery in patients with primary brain tumors or cancer that has spread from other places in the body to the brain (metastatic). Surgery is an important part of the treatment of brain tumors; however, it results in injury to surrounding brain tissue, leading to brain swelling. Dexamethasone is effective for controlling the swelling of the brain; however, dexamethasone can cause many unwanted side effects. To minimize the side effects of dexamethasone, the lowest dose needed to control swelling of the brain should be used. This research study is assessing the safety of using a lower than standard dose of dexamethasone after the surgery to control brain swelling.
Primary Outcome
Defined as a participant requiring more than 18 mg of dexamethasone beyond the planned dose per treatment arm during the 9 day period from surgery through post-operative day 8. Feasibility will be monitored sequentially (after each patient completes study treatment), by arm. The feasibility review boundary is based on a Wald sequential probability ratio test. Rates and associated 90% Clopper and Pearson binomial confidence limits will be estimated.
Conditions Studied
Interventions
- DRUG Dexamethasone
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2022-04-09 |
| Est. Completion | 2025-09-03 |
| Phase | Phase 2 |
What the registry record for NCT05139043 still lists
NCT05139043 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 87-participant average among 43 other Metastatic Malignant Neoplasm in the Brain trials with a reported enrollment target (70% lower).
The record links to 3 conditions, with Metastatic Malignant Neoplasm in the Brain appearing as the primary indexed condition, and to 1 intervention - of which Dexamethasone is the first listed.
NCT05139043 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05139043 about?
NCT05139043 is a clinical study titled "Low Dose Versus Standard Dose Dexamethasone for Reduction of Swelling in Patients with Primary or Metastatic Brain Tumors". This phase II trial studies whether low dose dexamethasone works as well as standard dose dexamethasone to reduce brain swelling after brain surgery in patients with primary brain tumors or cancer that has spread from other places in the body to the brain (metastatic). Surgery is an important part o...
What is the current status of trial NCT05139043?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2022-04-09. Estimated completion is 2025-09-03.
What conditions does trial NCT05139043 study?
This clinical trial studies the following conditions: Metastatic Malignant Neoplasm in the Brain, Malignant Brain Neoplasm, Recurrent Malignant Brain Neoplasm.
What interventions are being tested in trial NCT05139043?
The interventions under investigation include: Dexamethasone (DRUG).
Who is sponsoring clinical trial NCT05139043?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05139043 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05139043's enrollment target sits among peer trials
26 29th of 43 higher than 14 of 43 other Metastatic Malignant Neoplasm in the Brain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Malignant Neoplasm in the Brain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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