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

NCT01124253 | Completed Phase 3 DMC

• 1 other identifier: endo001
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

adjuvant therapy; non-small cell lung cancer; vinorelbine; cisplatin; recombinant human endostatin; endostar

Outcome Measures

Primary Outcomes (1)

• overall survival(OS)

  five years

Secondary Outcomes (2)

• disease-free survival(DFS)

  five years

• the toxicity and safety

  two years

Study Arms (2)

NP plus recombinant human endostatin

EXPERIMENTAL

Drug: recombinant human endostatin

vinorelbine plus cisplatin

NO INTERVENTION

Drug: recombinant human endostatin

Interventions

recombinant human endostatin 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

Also known as: endostar

NP plus recombinant human endostatin; vinorelbine plus cisplatin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Shanghai Municipal Science and Technology Commission: collaborator
• Shanghai Chest Hospital: collaborator
• Simcere Pharmaceutical Co., Ltd: collaborator

Study Sites (1)

The Lung Cancer Center of shanghai chest Hospital

Shanghai, 2000043, China

Location

Related Publications (1)

• 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.

  PMID: 22537906 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Endostatins; endostar protein

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors

Study Officials

• Liao Meilin, M.D.

  Shanghai Chest Hospital

  STUDY CHAIR

• Lu sun, M.D.

  Shanghai Chest Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 17, 2010
• Study Start: July 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: May 17, 2010

Record last verified: 2009-10

Locations

CN (1)