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

Non-small Cell Lung Cancer Clinical Trial

— Dengshan  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01124253
• Other study ID #: endo001
• Status: Completed
• Phase: Phase 3
• First received: May 6, 2010
• Last updated: May 14, 2010
• Start date: July 2007
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
China	The Lung Cancer Center of shanghai chest Hospital	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine	Shanghai Chest Hospital, Shanghai Municipal Science and Technology Commission, Simcere Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival(OS)		five years	Yes
Secondary	disease-free survival(DFS)		five years	Yes
Secondary	the toxicity and safety		two years	Yes