lung cancer
Conditions
Interventions
treatment group:maintenance with oral etoposide
observation group:no
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Aged 18-70 years old; Karnofsky performance score (KPS) 80; histological or cytological proof of extensive small cell lung cancer patients (staged by Veterans Administration Lung Study Group); complete 6 cycles of first-line chemotherapy with etoposide combined cisplatin and achieved complete response or partial response; at least one measurable lesion (the maximum diameter of the tumor was more than 20mm by conventional detection, or the maximum diameter of the tumor was more than 10mm by spiral CT); the expected survival time was more than 3 months; adequate organ function: hemoglobin >=10 g/dl, neutrophile granulocyte >=1.5 * 10^9/L, platelet >=125 * 109/L; serum creatinine >=1.25 * upper limit of normal (UNL); serum bilirubin?1.5 *UNL, AST and ALT>=1.5 *UNL without liver metastasis, AST and ALT by 2.5 *UNL with liver metastasis; received appropriate methods to contraception or having surgical sterilization during the clinical trial and the last 8 weeks after giving research drug; signed written informed consent before this study.
Exclusion criteria
Exclusion criteria: women with pregnancy or lactation; combined small cell lung cancer; central nervous system metastasis with symptom or suffering from uncontrollable mental illness; patients with other malignant tumors in the past five years (except for basal cell carcinoma of skin or cervical carcinoma in situ); patients suffering heart disease with clinical significance (i.e., active phase) (such as congestive heart failure, symptomatic coronary artery disease, and arrhythmia which can not be controlled by drugs) or myocardial infarction in the past 12 months; uncontrolled infection or severe metabolic disorder; peptic ulcer in the active stage which need to be treated, or malabsorption; undergoing major surgery within 3 weeks before screening; less than 4 weeks for withdrawal other clinical trial drugs; metastatic lesion in liver >1/3 liver volume; Grade 4 bone marrow suppression during the first-line chemotherapy; severe hyponatremia; not willing or can not comply the research scheme; can not comply to follow-up; others may affect clinical research and results determined the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactHongyang Lu
Zhejiang Cancer Hospital
Outcome results
None listed