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Adjuvant Vinorelbine Plus Cisplatin (NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by Chinese Academy of Sciences, December 2007
Sponsors and Collaborators: Chinese Academy of Sciences
Chinese Academy of Medical Sciences
Shanghai Jiao Tong University of Medicine
Beijing Chao Yang Hospital
Information provided by: Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT00576914
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: recombinant human endostatin
Phase III

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Cisplatin Vinorelbine Vinorelbine tartrate Endostatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Chinese Academy of Sciences:

Primary Outcome Measures:
  • overall survival [ Time Frame: five year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • recurrence-free survival and the toxicity and safety of the regimens [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1108
Study Start Date: June 2007
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator
vinorelbine plus cisplatin 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
B: 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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 shoul 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576914

Contacts
Contact: Xinling Liu, Bachelor 86-10-87788495 liuxinling1985@126.com
Contact: Fang Li, M.D. 86-13910145882 nc_lifang@yahoo.com.cn

Locations
China
The Lung Cancer Center of Cancer Hospital Recruiting
Beijing, China, 100021
Contact: Xinling Liu, Bachelor     86-10-87788495     liuxinling1985@126.com    
Contact: Fang Li, M.D.     86-13910145882     nc_lifang@yahoo.com.cn    
Sub-Investigator: Xiangru Zhang, M.D.            
Sponsors and Collaborators
Chinese Academy of Sciences
Chinese Academy of Medical Sciences
Shanghai Jiao Tong University of Medicine
Beijing Chao Yang Hospital
Investigators
Study Chair: Jie He, M.D. & Ph.D. Cancer Hospital ,Chinese Academy of Medical Sciences
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Cancer hospital and cancer institute, Chinese academy of medical sciences ( Hejie )
Study ID Numbers: 2006 BAI02A02[1]-01
Study First Received: December 18, 2007
Last Updated: January 10, 2008
ClinicalTrials.gov Identifier: NCT00576914  
Health Authority: China: Ministry of Health

Keywords provided by Chinese Academy of Sciences:
adjuvant therapy
non-small cell lung cancer
vinorelbine
cisplatin
recombinant human endostatin(endostar)

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Vinorelbine
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Endostatins
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009