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

NCT07542288 | Not Yet Recruiting Phase 2

• 1 other identifier: 2026-K04-02
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Brain metastases; Methylprednisolone; Dexamethasone; Peritumoral edema; Karnofsky performance status score; Biomarkers

Outcome Measures

Primary Outcomes (2)

• 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

  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);

  From enrollment to 6 weeks after the end of radiotherapy

Secondary Outcomes (8)

• Difference of Karnofsky performance status

  before hormone use, start date of radiotherapy, 4-6 weeks after radiotherapy

• Brain edema index (EI)

  before hormone use, within 1 week after radiotherapy, and 4-6 weeks after radiotherapy

• Cognitive function changes

  before hormone use, start date of radiotherapy, within 1 week after radiotherapy, and 4-6 weeks after radiotherapy

• Quality of life changes

  before hormone use, start date of radiotherapy, within 1 week after radiotherapy, and 4-6 weeks after radiotherapy

• Treatment tolerability

  From the first day of Glucocorticoidtherapy until 6 weeks after the end of radiotherapy

Study Arms (2)

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.

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.

Drug: Dexamethasone

Interventions

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.

Treatment group（Methylprednisolone）

Dexamethasone DRUG

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.

Control group（Dexamethasone）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• The Second Affiliated Hospital of Hainan Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China 570311, China

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Methylprednisolone; Adrenal Cortex Hormones; Dexamethasone

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Steroids, Fluorinated

Central Study Contacts

yuecan zeng

CONTACT

19946610752; wellyy2005@hainmc.edu.cn

junzhang chen

CONTACT

13189068479; chenjz0824@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 21, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)