III and IV stage NSCLS with regional lymph node metastasis
Conditions
Interventions
experiment group:paclitaxel liposome(135-175mg/m2 )+Saline(500ml) intravenous drip(3 hours)
cisplatin(75mg/m2)+Saline(500ml) .intravenous drip.
Control group:D1, 8: gemcitabine (1000mg/m2)+Saline (100ml) intravenous dirp (in half an hour)
D1: cisplatin (75mg/m2) + Saline (500ml) intravenous dirp.
Sponsors
Third Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Hospitalized patients both male and female, aged from 18 to 75 years; 2. ECOG performance status range from 0 to 2; 3. Pathologically diagnosised of non-small cell lung cancer, TNM stage was III and IV ,never receive any other chemotharapy; 4. According to RECIST/WHO evaluation criteria solid tumor efficacy, at least one lesions, measurable or evaluable, should be prompted by chest CT, and regional lymph node metastasis measurable or evaluable (including the neck and supraclavicular lymph node metastasis); 5. Expected survival >=3 months; 6. Hematology, liver and kidney function are normal, the blood and biochemical indicators should meet the following criteria: Bone marrow: absolute neutrophil count (ANC) >=1.5*10^9/L(1500/mm3); White blood cell count (WBC) >=4000/mm3; Platelet count >=100,000/mm3; Hemoglobin >=9 g/dL; Liver: serum bilirubin <=2 times upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5 times upper limit of normal (if liver metastases to allow AST, and ALT <=5 times normal limit; Kidney: serum creatinine <=1.5 times upper limit of normal; 7. Patients should understand and comply with the pilot program well, and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. history of cardiovascular disease: congestive heart failure> New York Heart Association (NYHA) level II. Patients with unstable angina (resting angina symptoms) or new onset of angina (in the last three months) or myocardial infarction patients in the last six months; 2. severe organic diseases, including active infection or cardiovascular disease; 3. poor hepatic function or severe cirrhosis, abnormal blood coagulation indicators; 4. poor general condition or cachexia; 5. patients had received radiotherapy or other local physical therapy within six months; 6. pregnant or lactating women; 7. patients receiving other anti-cancer treatment (such as chemotherapy, radiation therapy, immunosuppressive agents and chemoembolization and targeted agents); 8. patients is joining, have joined (1 day -4 weeks) or going to join another clinical research for drug test ; 9. patients allergic to drugs or drug accessories; 10. Some other cases could not be involved: for example, if the enrolled cases were influenced so that they failed to participate in or complete the clinical study (such as mental illness or drug abuse), or affect the analysis of results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (CR+PR);change about the regional lymph node metastasis(including number and size) and TNM stage assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival(PFS);Overall survival(OS);Median survival time(MST);1 year survival rate;time to progression(TTP);toxicity; | — |
Contacts
Public ContactZhou Xiangdong
Outcome results
None listed