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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(NSCLC) (Dengshan)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01124253
First Posted: May 17, 2010
Last Update Posted: May 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Shanghai Municipal Science and Technology Commission
Shanghai Chest Hospital
Simcere Pharmaceutical Co., Ltd
Information provided by:
Shanghai Jiao Tong University School of Medicine
  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.

Condition Intervention Phase
Non-small Cell Lung Cancer Drug: recombinant human endostatin Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • overall survival(OS) [ Time Frame: five years ]

Secondary Outcome Measures:
  • disease-free survival(DFS) [ Time Frame: five years ]
  • the toxicity and safety [ Time Frame: two years ]

Enrollment: 250
Study Start Date: July 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: endostar

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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, 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01124253


Locations
China
The Lung Cancer Center of shanghai chest Hospital
Shanghai, China, 2000043
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Shanghai Municipal Science and Technology Commission
Shanghai Chest Hospital
Simcere Pharmaceutical Co., Ltd
Investigators
Study Chair: Liao Meilin, M.D. Shanghai Chest Hospital
Study Director: Lu sun, M.D. Shanghai Chest Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Meilin liao, shanghai chest hospital
ClinicalTrials.gov Identifier: NCT01124253     History of Changes
Other Study ID Numbers: endo001
First Submitted: May 6, 2010
First Posted: May 17, 2010
Last Update Posted: May 17, 2010
Last Verified: October 2009

Keywords provided by Shanghai Jiao Tong University School of Medicine:
adjuvant therapy
non-small cell lung cancer
vinorelbine
cisplatin
recombinant human endostatin
endostar

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Vinorelbine
Cisplatin
Vinblastine
Endostatins
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors