Overview
Adjuvant Vinorelbine Plus Cisplatin (NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer
Status:
Unknown status
Unknown status
Trial end date:
2012-06-01
2012-06-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study was designed to determine whether adjuvant vinorelbine plus cisplatin and endostar prolongs overall survival compare to vinorelbine plus cisplatin alone among patients with completely resected IB-IIIA non-small-cell lung cancer. The patients with completely resected stage IB to stage IIIA non-small cell lung cancer were randomly assigned to the group of vinorelbine plus cisplatin plus endostar or to the group of vinorelbine plus cisplatin . The primary end point was overall survival; principal secondary end points were recurrence-free survival and the toxicity and safety of the regimens.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Chinese Academy of SciencesCollaborators:
Beijing Chao Yang Hospital
Chinese Academy of Medical Sciences
Shanghai Jiao Tong University School of MedicineTreatments:
Cisplatin
Endostatins
Vinblastine
Vinorelbine
Criteria
Inclusion Criteria:- 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 4-8
weeks.
- No evidence of tumor relapse prior to adjuvant therapy.
- Age 18-70, ECOG performance status 0-1.
- Normal hematologic function.Renal function , hepatic and cardiac function will be
within the acceptable ranges as following:serum bilirubin, AST and ALT levels below
1.5 times of normal value.
- No history of chemotherapy or radiotherapy;
- The patient should have well compliance for chemotherapy and follow up.Informed
consent should be obtained before treatment.
Exclusion Criteria:
- 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
drugs.
- Poor compliance.
- Not proper for the research according to the researchers' judgment.