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

NCT ID: NCT01124253

Last Updated: 2010-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2009-10-31

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.

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NP plus recombinant human endostatin

Group Type: EXPERIMENTAL

recombinant human endostatin

Intervention Type: DRUG

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

vinorelbine plus cisplatin

Group Type: NO_INTERVENTION

recombinant human endostatin

Intervention Type: DRUG

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

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

Intervention Type: DRUG

Other Intervention Names

endostar

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, 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Municipal Science and Technology Commission

OTHER_GOV

Sponsor Role: collaborator

Shanghai Chest Hospital

OTHER

Sponsor Role: collaborator

Simcere Pharmaceutical Co., Ltd

OTHER

Sponsor Role: collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

shanghai chest hospital

Principal Investigators

Liao Meilin, M.D.

Role: STUDY_CHAIR

Shanghai Chest Hospital

Lu sun, M.D.

Role: STUDY_DIRECTOR

Shanghai Chest Hospital

Locations

The Lung Cancer Center of shanghai chest Hospital

Shanghai, , China

Countries

China

References

Zhou Z, Chen ZW, Yang XH, Shen L, Ai XH, Lu S, Luo QQ. Establishment of a biomarker model for predicting bone metastasis in resected stage III non-small cell lung cancer. J Exp Clin Cancer Res. 2012 Apr 26;31(1):34. doi: 10.1186/1756-9966-31-34.

Reference Type: DERIVED

PMID: 22537906 (View on PubMed)

Other Identifiers

endo001

Identifier Type: -

Identifier Source: org_study_id