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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:
Collaborators:
Shanghai Municipal Science and Technology Commission
Shanghai Chest Hospital
Simcere Pharmaceutical Co., Ltd
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01124253
First received: May 6, 2010
Last updated: May 14, 2010
Last verified: October 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

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

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, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Meilin liao, shanghai chest hospital
ClinicalTrials.gov Identifier: NCT01124253     History of Changes
Other Study ID Numbers: endo001
Study First Received: May 6, 2010
Last Updated: May 14, 2010
Health Authority: China: Ethics Committee

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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Cisplatin
Endostatins
Vinorelbine
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014