Dengshan: Adjuvant Vinorelbine Plus Cisplatin(NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer(NSCLC)

Sponsor

Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT01124253

Collaborator

Shanghai Municipal Science and Technology Commission (Other), Shanghai Chest Hospital (Other), Simcere Pharmaceutical Co., Ltd (Other)

250

Enrollment

Location

Arms

Duration (Months)

9.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Drug: recombinant human endostatin	Phase 3

Detailed Description

It is an open labelled, randomized, mono-center phase III clinical trail.A total of 250 patients with resected stage IB to stage IIIA non-small cell lung cancer will either 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2007

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NP plus recombinant human endostatin	Drug: 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 Names: endostar
No Intervention: vinorelbine plus cisplatin	Drug: 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 Names: endostar

Arm

Intervention/Treatment

Experimental: NP plus recombinant human endostatin

Drug: 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 Names:

endostar

No Intervention: vinorelbine plus cisplatin

Drug: 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 Names:

endostar

Outcome Measures

Primary Outcome Measures

overall survival(OS) [five years]

Secondary Outcome Measures

disease-free survival(DFS) [five years]
the toxicity and safety [two years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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, 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 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.