Comparison of the Therapeutic Effects of Methylprednisolone and Dexamethasone on Peritumoral Edema During Radiotherapy for Brain Metastases:

April 14, 2026 updated by: The Second Affiliated Hospital of Hainan Medical University

Comparison of the Therapeutic Effects of Methylprednisolone and Dexamethasone on Peritumoral Edema During Radiotherapy for Brain Metastases:An Adaptive Phase II/III Seamless Prospective Clinical Study

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 security monitoring committee and uses statistical methods such as stratified block randomization and mixed effects models to ensure the scientific and ethical compliance of the data. This study is expected to provide high-level evidence-based basis for hormone selection during the perioperative radiotherapy period for patients with brain metastases, and optimize clinical practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Hainan
      • Haikou, Hainan, China, China 570311
        • The Second Affiliated Hospital of Hainan Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. 18 ≤ age ≤ 75 years old, gender not limited, generally acceptable, 40 ≤ KPS ≤ 80 points, the main reason for the patient's limited functional status is related neurological symptoms caused by edema of brain metastases; 2. Confirmed by cranial MRI or CT imaging, there is at least one brain metastasis with cerebral edema or neurological symptoms. All patients are scheduled to undergo WBRT (30 Gy/10f or 20 Gy/5f) or SBRT (20-40 Gy/1-6f, with ≤ 5 brain metastases and a maximum diameter of ≤ 5cm per lesion); 3. Expected survival of ≥ 3 months; 4. Having sufficient cognitive and understanding abilities, able to cooperate with scale assessments, and able to sign a written informed consent form (ICF); 5. Baseline neurological symptoms are stable (no need for emergency surgical decompression), and if surgery/radiotherapy has been performed, the following conditions must be met: postoperative/radiotherapy interval ≥ 4 weeks; 6. Baseline blood glucose/metabolism is controllable (e.g., HbA1c ≤ 8.0% in diabetes patients;If HbA1c is high, endocrinology evaluation is required and written permission for enrollment is granted.

Exclusion Criteria:

  • 1. Immediate surgical decompression is required, or there may be progressive cerebral herniation, intracranial pressure crisis, or life-threatening intracranial space occupying lesions present; 2. Has received systemic corticosteroid treatment within 7 days prior to the start of the study medication (such as due to the treatment of systemic lupus erythematosus, bronchial asthma, etc.); 3. Recent cranial surgery or radiation therapy (<4 weeks); 4. Individuals with contraindications to glucocorticoids or severe immunosuppression; 5. Suffering from serious basic diseases such as uncontrolled hypertension and diabetes (HbA1c>8%), untreated mental illness, active gastric ulcer, heart failure (NYHA III-IV grade), etc; 6. Pregnant/lactating women; 7. Unable to complete the primary assessment scale (severe cognitive/behavioral impairment) or unable to sustain Follow up period (e.g. no fixed address, difficult to ensure follow-up); 8. Participated in other intervention therapy trials within the past 4 weeks (which may affect the evaluation results), or is currently receiving drugs that may have serious drug interactions with the investigational drug; 9. Other serious systemic diseases or unsuitability.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group（Methylprednisolone）
Methylprednisolone group regimen: The total daily dose is 40-60 mg (oral or intravenous), starting from the diagnosis of brain metastasis and continuing until the end of radiotherapy. Subsequently, the dosage is gradually reduced by 20-50% of the total dose, and complete discontinuation is achieved within one week.
Drug: Methylprednisolone (Corticosteroid)
The total daily dose is 40-60 mg (oral or intravenous), starting from the diagnosis of brain metastasis and continuing until the end of radiotherapy. Subsequently, the dosage is gradually reduced by 20-50% of the total dose, and complete discontinuation is achieved within one week.
Active Comparator: Control group（Dexamethasone）
The dosing regimen for the dexamethasone group is: a total daily dose of 8-12 mg (oral or intravenous), starting from the diagnosis of brain metastasis and continuing until the end of radiotherapy. Subsequently, the dosage is gradually reduced by 20-50% of the total dose, and complete discontinuation is achieved within one week.
Drug: Dexamethasone
The total daily dose is 8-12 mg (oral or intravenous), starting from the diagnosis of brain metastasis and continuing until the end of radiotherapy. Subsequently, the dosage is gradually reduced by 20-50% of the total dose, and complete discontinuation is achieved within one week.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference of Karnofsky performance status
Time Frame: within one week after radiotherapy
The difference in Karnofsky performance status within one week after radiotherapy compared to baseline value;The minimum and maximum values are 0 and 100 points respectively, and the higher the score, the better the patient's health condition
within one week after radiotherapy
The incidence of adverse reactions related to hormone therapy
Time Frame: From enrollment to 6 weeks after the end of radiotherapy
The incidence of adverse reactions related to hormone therapy (≥ grade 2);
From enrollment to 6 weeks after the end of radiotherapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference of Karnofsky performance status
Time Frame: before hormone use, start date of radiotherapy, 4-6 weeks after radiotherapy
Differences in Karnofsky performance status changes at different time points during the perioperative radiotherapy period (before hormone use, start date of radiotherapy, 4-6 weeks after radiotherapy)；The minimum and maximum values are 0 and 100 points respectively, and the higher the score, the better the patient's health condition.
before hormone use, start date of radiotherapy, 4-6 weeks after radiotherapy
Brain edema index (EI)
Time Frame: before hormone use, within 1 week after radiotherapy, and 4-6 weeks after radiotherapy
Using cranial MRI to detect the differences in changes in cerebral edema index (EI) at different time points during the perioperative radiotherapy period (before hormone use, within 1 week after radiotherapy, and 4-6 weeks after radiotherapy) in patients
before hormone use, within 1 week after radiotherapy, and 4-6 weeks after radiotherapy
Cognitive function changes
Time Frame: before hormone use, start date of radiotherapy, within 1 week after radiotherapy, and 4-6 weeks after radiotherapy
The Montreal Cognitive Assessment Scale (MoCA) was used to evaluate the differences in cognitive function at different time points during the perioperative radiotherapy period (before hormone use, start date of radiotherapy, within 1 week after radiotherapy, and 4-6 weeks after radiotherapy)
before hormone use, start date of radiotherapy, within 1 week after radiotherapy, and 4-6 weeks after radiotherapy
Quality of life changes
Time Frame: before hormone use, start date of radiotherapy, within 1 week after radiotherapy, and 4-6 weeks after radiotherapy
Evaluate the differences in quality of life between two groups of patients at different time points during the perioperative radiotherapy period (before hormone use, start date of radiotherapy, within 1 week after radiotherapy, and 4-6 weeks after radiotherapy) using the QOL scale
before hormone use, start date of radiotherapy, within 1 week after radiotherapy, and 4-6 weeks after radiotherapy
Treatment tolerability
Time Frame: From the first day of Glucocorticoidtherapy until 6 weeks after the end of radiotherapy
Differences in the incidence of radiotherapy interruption or delay (>3 days) and the incidence of radiotherapy-related neurological adverse effects (RTOG grade ≥3)
From the first day of Glucocorticoidtherapy until 6 weeks after the end of radiotherapy
Survival outcomes
Time Frame: For intracranial progression-free survival (PFS): assessed at baseline, then every 3 months until disease progression, up to 2 years; For overall survival (OS): assessed at baseline, then every 3 months until death from any cause, up to 2 years.
including intracranial progression-free survival (PFS) and overall survival (OS)
For intracranial progression-free survival (PFS): assessed at baseline, then every 3 months until disease progression, up to 2 years; For overall survival (OS): assessed at baseline, then every 3 months until death from any cause, up to 2 years.
Incidence of adverse events
Time Frame: From the first day of Glucocorticoidtherapy until 6 weeks after the end of radiotherapy
Incidence, severity (according to CTCAE v5.0), and correlation with the study drug of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs);
From the first day of Glucocorticoidtherapy until 6 weeks after the end of radiotherapy
Exploratory biomarker analysis
Time Frame: Baseline (first day of radiotherapy, prior to radiotherapy); and immediately after completion of radiotherapy (last day of radiotherapy).
Dynamically monitor serum IL-6 and S100B levels to analyze the correlation between changes in their serum levels and the occurrence and severity of radiotherapy-induced neurotoxicity.
Baseline (first day of radiotherapy, prior to radiotherapy); and immediately after completion of radiotherapy (last day of radiotherapy).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Second Affiliated Hospital of Hainan Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026-K04-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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