Brain Metastases From Solid TumorsPhase 2/3NCT07542288
Comparison of the Therapeutic Effects of Methylprednisolone and Dexamethasone on Peritumoral Edema During Radiotherapy for Brain Metastases:
A Phase 2/3 study testing Methylprednisolone (Corticosteroid) and Dexamethasone in people with Brain Metastases From Solid Tumors, run by The Second Affiliated Hospital of Hainan Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Metastases From Solid Tumors
- What is being tested?
- Methylprednisolone (Corticosteroid) and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2026to 30 Jun 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China 570311
About this study
Official title: 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.
- Conditions
- Brain Metastases From Solid Tumors
- Being tested
- Methylprednisolone (Corticosteroid), Dexamethasone
- Keywords
- Brain metastases, Methylprednisolone, Dexamethasone, Peritumoral edema, Karnofsky performance status score, Biomarkers
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone (Corticosteroid)Drug
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.
DexamethasoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group（Methylprednisolone） | Experimental | 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. Receives: Drug: Methylprednisolone (Corticosteroid) |
| Control group（Dexamethasone） | Active comparator | 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. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of Karnofsky performance status
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
Measured: within one week after radiotherapy
The incidence of adverse reactions related to hormone therapy
The incidence of adverse reactions related to hormone therapy (≥ grade 2);
Measured: From enrollment to 6 weeks after the end of radiotherapy
Secondary outcomes (8)
Difference of Karnofsky performance status
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.
Measured: before hormone use, start date of radiotherapy, 4-6 weeks after radiotherapy
Brain edema index (EI)
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
Measured: before hormone use, within 1 week after radiotherapy, and 4-6 weeks after radiotherapy
Cognitive function changes
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)
Measured: before hormone use, start date of radiotherapy, within 1 week after radiotherapy, and 4-6 weeks after radiotherapy
Quality of life changes
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
Measured: before hormone use, start date of radiotherapy, within 1 week after radiotherapy, and 4-6 weeks after radiotherapy
Treatment tolerability
Differences in the incidence of radiotherapy interruption or delay (>3 days) and the incidence of radiotherapy-related neurological adverse effects (RTOG grade ≥3)
Measured: From the first day of Glucocorticoidtherapy until 6 weeks after the end of radiotherapy
Survival outcomes
including intracranial progression-free survival (PFS) and overall survival (OS)
Measured: 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
Incidence, severity (according to CTCAE v5.0), and correlation with the study drug of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs);
Measured: From the first day of Glucocorticoidtherapy until 6 weeks after the end of radiotherapy
Exploratory biomarker analysis
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.
Measured: Baseline (first day of radiotherapy, prior to radiotherapy); and immediately after completion of radiotherapy (last day of radiotherapy).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Metastases From Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Hainan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542288
- Sponsor's protocol ID
- 2026-K04-02
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07542288
- Acronym / sponsor ID
- 2026-K04-02
- Conditions
- Brain Metastases From Solid Tumors
- Keywords
- Brain metastases, Methylprednisolone, Dexamethasone, Peritumoral edema, Karnofsky performance status score, Biomarkers
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Hainan Medical UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group（Methylprednisolone） | Experimental | Drug: Methylprednisolone (Corticosteroid)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. |
| Control group（Dexamethasone） | Active comparator | Drug: DexamethasoneThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Treatment group（Methylprednisolone） |
| DexamethasoneThe 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. | Drug | Control group（Dexamethasone） |
Primary outcome
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
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);
8 secondary outcomes
Difference of Karnofsky performance status
Time frame: 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
Cognitive function changes
Time frame: 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
Treatment tolerability
Time frame: 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.
Incidence of adverse events
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Methylprednisolone (Corticosteroid) and Dexamethasone in people with Brain Metastases From Solid Tumors, run by The Second Affiliated Hospital of Hainan Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yuecan zeng (19946610752, wellyy2005@hainmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of Karnofsky performance status (time frame: within one week after radiotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.