Malignant neoplasm metastasis in brain
Conditions
Interventions
Combination therapy:????????????
Sponsors
Department of Radiation Oncology, Third Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Male or female, Aged 18-70 years; 2) ECOG score 0-1; 3) RTOG neurological status score 0-1; 4) Histopathological diagnosis of lung cancer; 5) Brain metastasis was diagnosed by imaging within 2 weeks before enrollment (the primary tumor disease of the patient may not be treated systematically); 6) Intracranial metastatic lesions can be measured and evaluated by MRI/CT; 7) Intracranial radiotherapy was not performed before enrollment; 8) Patients had received at least 2 courses of systemic chemotherapy or radiotherapy before have progressed; 9) Intracranial lesions are suitable for whole brain radiotherapy; 10) Patients can independently complete the neurocognitive test and QOL questionnaire; 11) Both men and women at the gestational age must agree to take adequate contraceptive measures throughout the study period; 12) Biochemical test indexes must meet the following standards before enrollment: a. WBC count 2.0x10^9/L b. Neutrophil count 1.5x10^9/L c. Platelet count 100x10^9/L d. Hemoglobin 90g/L e. alanine aminotransferase and straw aminotransferase 45 ml/min (Cockcroft-Gault formula).
Exclusion criteria
Exclusion criteria: 1) Metastatic lesions were located in the brain stem or other locations, making it unsuitable for radiotherapy; 2) Corticosteroid drug was used within 2 weeks before enrollment; 3) Patients with metal implants or claustrophobia not suitable for MRI; 4) Patients had treatment history of checkpoint inhibitors, such as anti-CTLA-4/PD-1/PD-L1; 5) Patients with active autoimmune diseases requiring hormone or immunomodulator treatment, such as rheumatoid arthritis, ankylosing spondylitis, type I diabetes, psoriasis, vitiligo, immune-related thyroid dysfunction, etc.; 6) Patients with acute or chronic infectious diseases, such as hepatitis B, hepatitis C, tuberculosis and HIV; 7) Patients with uncontrolled intracranial organic diseases or severe mental diseases, such as cerebral infarction, intracranial vascular malformations, schizophrenia, etc.; 8) Patients were allergy to the ingredients of the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracranial Tumor Progression-free Survival Time;Early and Late Adverse Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intracranial Tumor Control Rate;Overall Survival;Maximum Response Rate of Distant Non-Irradiated Disease;Quality of Life;Early and Late Adverse Events;Neurocognitive Function Score; | — |
Countries
China
Contacts
Public ContactGu Wendong
Department of Radiation Oncology, Third Affiliated Hospital of Soochow University
Outcome results
None listed