small cell lung cancer
Conditions
Interventions
Test group:Nedplatin 80mg/m2 iv d1
Vp16 100mg/m2 iv d1-d3
Control group:DDP75mg/m2 iv d1-2
Vp-16 100mg/m2 iv d1-d3
Sponsors
Department of Medical Oncology, Beijing Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Male and female. Childbearing age patients used contraceptive measures which are recognized by the Medical during the research or within 6 months after the end of the study; (2) cytologically or histologically confirmed extensive SCLC; (3) having RECIST V1.1 defined measurable lesion (>=10 mm) CT or MRI scan lesions; (4) The physical condition is still good: ECOG score 0-2; (5) the expected survival are more than 3 months; (6) bone marrow function without significantly impaired: WBC >=4*10^9/L, platelets >=100*10^9/L, Hb >=9.0g/dL; (7) the liver, kidney function was normal: TBL <=1.5*UNL, ALT/AST <=1.5*UNL; Cr <=1.5*UNL; (8) For the subjects used other drugs in the past, at least after a 4-week washout period before entering the trial; (9) no serious history of drug allergy.
Exclusion criteria
Exclusion criteria: (1) Existing severe acute infection, and is not controlled; suppurative and chronic infection, wound delayed healing; (2) liver and kidney dysfunction: TBL> 1.5*L, transaminase ALT/AST> 3*UNL (ALT and AST in existing liver metastasis patients can be increased five times); Cr> 1.5*UNL; (3) pregnancy, breast-feeding women, or fertility patients but did not take contraceptive measures; (4) uncontrolled brain metastases; (5) participate in other drug test and the anti-tumor therapy in last 4 weeks; (6) patients with difficult to control nerves, mental illness or mental disorders, poor compliance can not cope with and described the response to treatment; primary brain tumors or CNS metastases without the control of the disease, with significant cranial hypertension or nervemental symptoms; (7) other malignant diseases, cervical carcinoma in situ and non-melanoma skin cancer, unless previous malignant disease in evidence five years ago had been diagnosed and treated, and no later recurrence. There are low-grade (Gleason score <=6) in patients with localized prostate cancer diagnosis is less than five years can also be enrolled; (8) patients to participate in other clinical trials meanwhile; (9) The researchers believe that patients should not participate in the trials of other circumstances.
Countries
China
Contacts
Public ContactShucai Zhang
Outcome results
None listed