Phase III Study of Adjuvant Vinorelbine Plus Cisplatin (NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer
- Histologically confirmed non-small cell lung cancer, the pathology type includes
squamous cell carcinoma, adenocarcinoma, large-cell carcinoma, and any mixed type of
the 3 types mentioned above.
- Stage IB-IIIA non-small cell lung cancer, tumor was completely resected (The type of
surgery including lobectomy, left side pneumonectomy,bi-lobectomy).
- The time from surgery to first dose of adjuvant chemotherapy are mandatory between
- No evidence of tumor relapse prior to adjuvant therapy.
- Age 18-70, Eastern Cooperative Oncology Group(ECOG) performance status 0-1.
- Normal hematologic function.Renal function , hepatic and cardiac function will be
within the acceptable ranges as following:serum bilirubin, aspartate
aminotransferase(AST)and alamine aminotransferase(ALT)levels below 1.5 times of
- No history of chemotherapy or radiotherapy;
- The patient should have well compliance for chemotherapy and follow up
- Informed consent should be obtained before treatment.
- The histological or cytological documents do not match the inclusion criteria.
- Right side pneumonectomy or any kind of incompletely resected surgery.
- The recruitment time are beyond 8 weeks from surgery.
- Any concurrent acute or chronic systemic diseases or psychiatric diseases, which
might both increase the risks of the research itself or the medical therapy and
influence the research results analysis. The researchers can make a judge for the
following conditions to tell whether they are fit for this research:Uncontrolled high
blood pressure, unstable angina , myocardial infarction , uncontrolled arrhythmia,or
congestive heart failure with clinical symptoms within 12 weeks before
randomization.Evidence of anemia from electrocardiographic manifestation or heart
valve disease with confirmed clinical diagnosis.Clinically significant active
infection state due to bacteria, virus and fungi invasion. Patients with grade II
arrhythmia, grade II myocardial anemia, grade II abnormal cardiac troponin T, grade
II high blood pressure or left ventricle ejection fraction (LVEF) less than 50
percent according to CTC 3.0 are not permitted to enrol the study.
- women with pregnant or lactation.
- Before enter the group,the patients had other malignant tumors except for
non-melanoma skin cancer, carcinoma in situ and cured early-stage prostate cancer.
- With allergic constitution or possible allergic reflection to any known research
- Poor compliance.
- Not proper for the research according to the researchers' judgment.