Non-small cell lung cancer (NSCLC) with multiple brain metastases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged >=18 years with newly diagnosed brain metastases. 2. Primary tumor histologically confirmed as non-small cell lung cancer (NSCLC). 3. Radiologically confirmed brain metastases (5-20 lesions). 4. Eastern Cooperative Oncology Group (ECOG) performance status of =6 months. 6. Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential. 7. Unsuitable for or declining stereotactic radiosurgery (SRS).
Exclusion criteria
Exclusion criteria: 1. Prior whole-brain radiotherapy, SRS, or surgical resection for brain metastases. 2. Diffuse leptomeningeal disease. 3. Hippocampal involvement/infiltration. 4. Uncontrolled extensive extracranial metastatic disease despite systemic therapy. 5. Significant medical or psychiatric conditions, as determined by the investigator, that would interfere with treatment or follow-up. 6. Dementia, persistent psychotic episodes, or moderate to severe depression (as assessed by PHQ-9). 7. History of stroke within the past 3 months. 8. Symptomatic brain metastases limiting activities of daily living (ADL). 9. Rapid progression of brain lesions. 10. Inability to provide informed consent. 11. Radiological evidence of hydrocephalus. 12. Diagnosis of primary brain tumor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracranial Progression-Free Survival (iPFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Adverse Event (AE);Local Recurrence-Free Survival(LRFS); | — |
Countries
China
Contacts
The First Affiliated Hospital of Xiamen University