Adjuvant Vinorelbine Plus Cisplatin (NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer
NCT ID: NCT00576914
Last Updated: 2010-03-09
Study Results
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Basic Information
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UNKNOWN
PHASE3
1108 participants
INTERVENTIONAL
2007-06-30
2012-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
vinorelbine plus cisplatin plus recombinant human endostatin
recombinant human endostatin
recombinant human endostatin 15mg per ampul for injection 7.5mg/m2 IV (in the vein) on 1st to 14th days of a 21- day cycle, totally 4 cycles are needed
B
vinorelbine plus cisplatin
recombinant human endostatin
recombinant human endostatin 15mg per ampul for injection 7.5mg/m2 IV (in the vein) on 1st to 14th days of a 21- day cycle, totally 4 cycles are needed
Interventions
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recombinant human endostatin
recombinant human endostatin 15mg per ampul for injection 7.5mg/m2 IV (in the vein) on 1st to 14th days of a 21- day cycle, totally 4 cycles are needed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Shanghai Jiao Tong University School of Medicine
OTHER
Beijing Chao Yang Hospital
OTHER
Chinese Academy of Sciences
OTHER_GOV
Responsible Party
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Cancer hospital and cancer institute, Chinese academy of medical sciences
Principal Investigators
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Jie He, M.D. & Ph.D.
Role: STUDY_CHAIR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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The Lung Cancer Center of Cancer Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Douillard JY, Rosell R, De Lena M, Carpagnano F, Ramlau R, Gonzales-Larriba JL, Grodzki T, Pereira JR, Le Groumellec A, Lorusso V, Clary C, Torres AJ, Dahabreh J, Souquet PJ, Astudillo J, Fournel P, Artal-Cortes A, Jassem J, Koubkova L, His P, Riggi M, Hurteloup P. Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial. Lancet Oncol. 2006 Sep;7(9):719-27. doi: 10.1016/S1470-2045(06)70804-X.
Other Identifiers
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2006 BAI02A02[1]-01
Identifier Type: -
Identifier Source: org_study_id
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