Non-small cell lung cancer
Conditions
Interventions
Group TL:Day 1: TAX 175mg/m2/day
Group TC:Day 1: TAX 175mg/m2/day
Day 2:carboplatinAUC=5(mg/ml?min).Each therapy cycle consists of 21 days. Maximun: 6 cycles
Sponsors
81th Hospital of PLA
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 70 years old; male or female patients; 2. With the diagnosis of NSCLC confirmed by pathological or cytology tests except pure bronchioloalveolar carcinoma 3. The phase of IIIB or IV NSCLC patients with massive metastasis 4. the first-line chemotherapy, if the patients had neoadjuvant chemotherapy or adjuvant chemotherapy, the time is not less than 6 months; 5.The patients did not receive any palliative chemotherapy or molecular targeted drugs for NSCLC treatment (including monoclonal antibodies or small molecule tyrosine kinase inhibitors, etc.) 6.The patients received the radiotherapy must satisfy the following conditions: The main foci didn’t received the radiotherapy or progress after radiotherapy; The previous anti-cancer treatment toxicity (==3 months; 10. Laboratory parameters: Bone marrow function: ANC>=1.5*10^9/L; PLT>=80*10^9/L; HB>=90g/L; Hepatic function: STB and CB==60 ml/min (Cockcroft-Gault); Coagulation function:PT INR)=<ULN*1.5; 11. Female: postmenopausal period or have received sterilization operation, or contraception during treatment and within 6 months after the therapy; non-breast feeding period; Male: have received sterilization operation, or contraception during treatment and within 6 months after the therapy; 12. Voluntary to participate and sign informed consent document;
Exclusion criteria
Exclusion criteria: 1. Allergic to platinum drugs used in the trial; 2. The patients are allergic to castor oil; 3. Have received surgical intervention or ratiotherapy for primacy foci within the latest 4weeks; 4. Have received drugs (including Chinese Medicine) with anti-lung cancer properties approved by SFDA; 5. Have the previous anti-cancer treatment toxicity (>=CTCAE 3) 6. Active brain metastasis that requires therapy; 7. Narrowing of main bronchi or lobe bronchi and superior vena cava syndrome caused by tumor compression; uncontrolled moderate to severe pleural, pericardial effusion and ascites; 8.Have the malignant tumor of other tissue within 5 years(excluding cerical cancer , basal cell carcinoma or squamous carcinoma); 9.Severe cardiaovascular diseases including uncontrolled hypertension, unstable angina pectoris, cardiac infarction, heart failure (>2 according to NYHA standard) and severe cardiac arrhythmia; 10. History of hemorrhage (>=CTCAE 3) within the latest 4 weeks; 11. Patients needing anticoagulation therapy or vitamin K antagonists (excluding prevention use of small dosage of warfarin=<1mg /d and aspirin=<100mg/d ); 12. Have participated in other drug trial within the latest 4 weeks; 13. Severe infection that requires intravenous use of antibiotics, anti-fungal or anti-virus therapy; 14. The patients with mental disease have the poor compliance; 15. Other patients that are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life;Disease control rate;Overall survival;Safety;Objective response rate; | — |
Countries
China
Contacts
Public ContactDonghu Sui
Outcome results
None listed