Clinical trial NCT00576914: Adjuvant Vinorelbine Plus Cisplatin (NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer
Official title: Adjuvant Vinorelbine Plus Cisplatin Versus Vinorelbine Plus Cisplatin Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer (Phase III Study, Randomized, Open, Multi-center)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Keywords: adjuvant therapy
non-small cell lung cancer
vinorelbine
cisplatin
recombinant human endostatin(endostar)
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: Chinese Academy of Medical Sciences
name: Shanghai Jiao Tong University School of Medicine
name: Beijing Chao Yang Hospital
First posted: 2007-12-19
Enrollment: 1108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: It is an open labelled, randomized, multi-center phase III clinical trail.A total of 1108 patients with resected stage IB to stage IIIA non-small cell lung cancer will either ether the group of vinorelbine plus cisplatin plus endostar or the group of vinorelbine plus cisplatin randomly. The primary end point was overall survival; principal secondary end points were recurrence-free survival and the toxicity and safety of the regimens.The major inclusive criteria are pathological confirmed non-small cell lung cancer after complete resection and can tolerate chemotherapy safely.The tissue and blood samples will be banked for further investigation. All of the enrolled patients will be followed up until death or over 5 years.

Eligibility 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.

Primary outcomes:
measure: overall survival
timeFrame: five year
Secondary outcomes:
measure: recurrence-free survival and the toxicity and safety of the regimens
timeFrame: 5 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Lung Cancer Center of Cancer Hospital
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Jie He, M.D. & Ph.D.
role: STUDY_CHAIR
References:
citation: 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.