Adjuvant Vinorelbine Plus Cisplatin (NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer
Primary Purpose
Non-small Cell Lung Cancer
Status
Unknown status
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, 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 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 Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
A
B
Arm Description
vinorelbine plus cisplatin plus recombinant human endostatin
vinorelbine plus cisplatin
Outcomes
Primary Outcome Measures
overall survival
Secondary Outcome Measures
recurrence-free survival and the toxicity and safety of the regimens
Full Information
NCT ID
NCT00576914
First Posted
December 18, 2007
Last Updated
March 8, 2010
Sponsor
Chinese Academy of Sciences
Collaborators
Chinese Academy of Medical Sciences, Shanghai Jiao Tong University School of Medicine, Beijing Chao Yang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00576914
Brief Title
Adjuvant Vinorelbine Plus Cisplatin (NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese Academy of Sciences
Collaborators
Chinese Academy of Medical Sciences, Shanghai Jiao Tong University School of Medicine, Beijing Chao Yang Hospital
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.
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.
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.
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
1108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
vinorelbine plus cisplatin plus recombinant human endostatin
Arm Title
B
Arm Type
No Intervention
Arm Description
vinorelbine plus cisplatin
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
Time Frame
five year
Secondary Outcome Measure Information:
Title
recurrence-free survival and the toxicity and safety of the regimens
Time Frame
5 year
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, 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinling Liu, Bachelor
Phone
86-10-87788495
Email
liuxinling1985@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fang Li, M.D.
Phone
86-13910145882
Email
nc_lifang@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie He, M.D. & Ph.D.
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
The Lung Cancer Center of Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinling Liu, Bachelor
Phone
86-10-87788495
Email
liuxinling1985@126.com
First Name & Middle Initial & Last Name & Degree
Fang Li, M.D.
Phone
86-13910145882
Email
nc_lifang@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Xiangru Zhang, M.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
16945766
Citation
Douillard JY, Rosell R, De Lena M, Carpagnano F, Ramlau R, Gonzales-Larriba JL, Grodzki T, Pereira JR, Le Groumellec A, Lorusso V, Clary C, Torres AJ, Dahabreh J, Souquet PJ, Astudillo J, Fournel P, Artal-Cortes A, Jassem J, Koubkova L, His P, Riggi M, Hurteloup P. Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial. Lancet Oncol. 2006 Sep;7(9):719-27. doi: 10.1016/S1470-2045(06)70804-X. Erratum In: Lancet Oncol. 2006 Oct;7(10):797.
Results Reference
background
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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
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