Brain metastasis
Conditions
Interventions
Phase II Trial Group:Methylprednisolone (MP), total daily dose of 40-60 mg (oral or intravenous), continued until the end of radiotherapy, then discontinued within 1 week
Phase II Control Group:Dexamethasone (DEX), total daily dose of 8-12 mg (oral or intravenous), continued until the end of radiotherapy, then discontinued within 1 week
Phase III Trial Group:Methylprednisolone (MP), total daily dose of 40-60 mg (oral or intravenous), continued until the end of radiotherapy, then discontinued within 1 week
Phase III Control Group:Dexamethasone (DEX), total daily dose of 8-12 mg (oral or intravenous), continued until the end of radiotherapy, then discontinued within 1 week
Sponsors
The Second Affiliated Hospital of Hainan Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–75 years, any gender, generally good condition, KPS 40–80, with functional limitation primarily caused by neurological symptoms due to brain metastasis-associated edema; 2. Confirmed by cranial MRI or CT to have at least one brain metastasis accompanied by cerebral edema or neurological symptoms; all patients are planned for WBRT (30 Gy/10 fractions or 20 Gy/5 fractions) or SBRT (20–40 Gy/1–6 fractions, with =3 months; 4. Sufficient cognitive and comprehension ability to cooperate with scale assessments and sign the written informed consent form (ICF); 5. Stable baseline neurological symptoms (no need for emergency surgical decompression); if prior brain surgery or radiotherapy was performed, the interval since surgery/radiotherapy must be >=4 weeks; 6. Controllable baseline glucose/metabolism (e.g., HbA1c <=8.0% for diabetic patients; if HbA1c is higher, endocrinology evaluation and written approval for enrollment are required).
Exclusion criteria
Exclusion criteria: 1. Conditions requiring immediate surgical decompression, or presence of progressive brain herniation, intracranial pressure crisis, or life-threatening intracranial space-occupying lesions; 2. Receipt of systemic glucocorticoid therapy within 7 days prior to the initiation of the study drug (e.g., for treatment of systemic lupus erythematosus, bronchial asthma, etc.); 3. Recent craniocerebral surgery or radiotherapy ( 8%), untreated psychiatric disorders, active peptic ulcer, or heart failure (NYHA Class III-IV); 6. Pregnant or lactating women; 7. Inability to complete primary assessment scales (due to severe cognitive/behavioral impairment) or inability to ensure long-term follow-up (e.g., no fixed address, difficulty guaranteeing follow-up); 8. Participation in other interventional therapeutic trials within the past 4 weeks (which may affect assessment results), or concurrent use of medications that may have serious drug interactions with the study drug; 9. Other severe systemic diseases or conditions rendering the patient unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in KPS score within 1 week after radiotherapy;Incidence rate of grade >=2 hormone therapy-related adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in KPS score at different time points during the peri-radiotherapy period;Change in brain edema index (EI);Cognitive function difference;Quality of life difference;Incidence rate of radiotherapy interruption or delay (>3 days);Incidence rate of radiotherapy-induced neurological toxicity (RTOG grade >=3);Intracranial progression-free survival (PFS) and overall survival (OS);Incidence rate and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs);Change in serum IL-6 and S100B levels; | — |
Countries
China
Contacts
Public ContactZeng Yuecan
The Second Affiliated Hospital of Hainan Medical University
Outcome results
None listed