Brain Metastases from Lung Cancer
Conditions
Interventions
Control group:Standard dose radiotherapy combined
Experimental group:Standard dose radiotherapy combined with Cranifu Pills 9g oral administration twice daily
Sponsors
Chongqing Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1)Patients with non-small cell lung cancer (NSCLC) confirmed by histology or cytology who have untreated or progressive brain metastases. 2)Age =18 years with no restrictions on gender. 3)ECOG performance status =2. 4)Life expectancy =3 months; 5)At least one measurable lesion (with a maximum diameter =0.3 cm) before the intervention. 6)Voluntarily participating in this clinical study understanding study the procedures and able to provide written informed consent. 7)Major organ functions meet the following criteria (no blood transfusion within 2 weeks prior to the screening of blood routine tests): Absolute Neutrophil Count (ANC) =1.5×109/L. Platelets (PLT) =100×109/L; Hemoglobin (Hb) =90 g/L; Total Bilirubin (TBIL) =1.5×Upper Limit of Normal (ULN); Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) =3×ULN (=5×ULN if there is liver metastasis); Serum creatinine =1.5×ULN; Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) =1.5×ULN.
Exclusion criteria
Exclusion criteria: 1)Planning to participate in other clinical studies during the course of this study; 2)Patients with a history of leptomeningeal metastasis or current leptomeningeal metastasis; 3)Known allergy to any of the traditional Chinese medicinal ingredients in the Lu Fu Wan formula or to any of its excipients; 4)Presence of active or uncontrolled serious infection; 5)Having undergone surgical procedures within 4 weeks prior to the intervention; 6)Having serious cardiovascular and cerebrovascular diseases including but not limited to: Severe cardiac rhythm or conduction abnormalities such as ventricular arrhythmias requiring clinical intervention or second- or third-degree atrioventricular block; Acute coronary syndrome congestive heart failure (New York Heart Association [NYHA] functional class =II) myocardial infarction aortic dissection stroke or other grade 3 or higher cardiovascular and cerebrovascular events within 6 months prior to the first intervention; • Uncontrolled hypertension from a clinical perspective. 7)Presence of concomitant diseases (such as severe diabetes thyroid disease and psychiatric disorders) or any other conditions that in the judgment of the study physician may seriously endanger patient safety or affect the patient's ability to complete this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;Neurocognitive function;Objective Remission Rate; | — |
Countries
china
Contacts
Public ContactMin Qiu
Chongqing Traditional Chinese Medicine Hospital
Outcome results
None listed