Phase 2 Trial Comparing Methylprednisolone and Dexamethasone
Summary
NIH registered a Phase 2/III multicenter clinical trial (NCT07542288) comparing methylprednisolone (40-60 mg/day) and dexamethasone (8-12 mg/day) for treating peritumoral edema in brain metastasis patients during radiotherapy. The adaptive seamless design enrolls patients aged 18-75 with KPS scores of 40-80, beginning with 120 cases in stage II and expanding to up to 400 total cases in stage III. The primary endpoints are change in KPS score and incidence of grade 2 or higher hormone-related adverse reactions within one week after radiotherapy.
What changed
This entry registers a Phase 2/III clinical trial comparing two corticosteroids for managing peritumoral edema in brain metastases patients receiving radiotherapy. The trial employs an adaptive seamless design, beginning with 120 participants in stage II and expanding to up to 400 in stage III, with a primary focus on KPS score changes and corticosteroid-related adverse event rates.
For clinical operations teams and oncology researchers, this registration signals an upcoming comparative evaluation of standard-of-care corticosteroids that may inform edema management protocols. Sites planning to participate should review inclusion criteria (KPS 40-80, age 18-75, planned whole brain or stereotactic radiotherapy) and prepare for potential protocol amendments as the adaptive design may adjust sample size between stages.
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Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Comparison of the Therapeutic Effects of Methylprednisolone and Dexamethasone on Peritumoral Edema During Radiotherapy for Brain Metastases:
Phase 2 NCT07542288 Kind: PHASE2 Apr 21, 2026
Abstract
This study is a multicenter, open label, randomized controlled, adaptive phase II/III seamless design clinical trial aimed at comparing the efficacy and safety of methylprednisolone (MP) and dexamethasone (DEX) in the treatment of peritumoral edema in patients with brain metastases during radiotherapy. The research plan includes brain metastasis patients aged 18-75 years, with KPS scores of 40-80, who plan to undergo whole brain radiotherapy or stereotactic radiotherapy. They will be randomly divided into MP group (40-60 mg/day) or DEX group (8-12 mg/day) in a 1:1 ratio, and medication will be continued until the end of radiotherapy, followed by gradual reduction and cessation within one week. The study is divided into two stages: the first stage (stage II exploration) includes 120 cases to preliminarily evaluate the efficacy and safety, and provide a basis for re estimating the sample size in the second stage; The second stage (Phase III confirmation) will expand the sample size based on the results after analysis during the transition period, with a total sample size of no more than 400 cases. The primary endpoint was the change in KPS score and the incidence of grade ≥ 2 hormone related adverse reactions within one week after radiotherapy. Secondary endpoints include cerebral edema index, cognitive function, quality of life, radiotherapy interruption rate, neurotoxicity, survival, and serum biomarkers (IL-6, S100B). The study is supervised by an independent data securit...
Conditions: Brain Metastases From Solid Tumors
Interventions: Methylprednisolone (Corticosteroid), Dexamethasone
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