Adjuvant Vinorelbine Plus Cisplatin(NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer(NSCLC) (Dengshan)
Primary Purpose
Non-small Cell Lung Cancer
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
recombinant human endostatin
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring adjuvant therapy, non-small cell lung cancer, vinorelbine, cisplatin, recombinant human endostatin, endostar
Eligibility 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.
Sites / Locations
- The Lung Cancer Center of shanghai chest Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
NP plus recombinant human endostatin
vinorelbine plus cisplatin
Arm Description
Outcomes
Primary Outcome Measures
overall survival(OS)
Secondary Outcome Measures
disease-free survival(DFS)
the toxicity and safety
Full Information
NCT ID
NCT01124253
First Posted
May 6, 2010
Last Updated
May 14, 2010
Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
Shanghai Municipal Science and Technology Commission, Shanghai Chest Hospital, Simcere Pharmaceutical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01124253
Brief Title
Adjuvant Vinorelbine Plus Cisplatin(NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer(NSCLC)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
Shanghai Municipal Science and Technology Commission, Shanghai Chest Hospital, Simcere Pharmaceutical Co., Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
adjuvant therapy, non-small cell lung cancer, vinorelbine, cisplatin, recombinant human endostatin, endostar
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NP plus recombinant human endostatin
Arm Type
Experimental
Arm Title
vinorelbine plus cisplatin
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
recombinant human endostatin
Other Intervention Name(s)
endostar
Intervention Description
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
Primary Outcome Measure Information:
Title
overall survival(OS)
Time Frame
five years
Secondary Outcome Measure Information:
Title
disease-free survival(DFS)
Time Frame
five years
Title
the toxicity and safety
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liao Meilin, M.D.
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lu sun, M.D.
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Study Director
Facility Information:
Facility Name
The Lung Cancer Center of shanghai chest Hospital
City
Shanghai
ZIP/Postal Code
2000043
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
22537906
Citation
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.
Results Reference
derived
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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)
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