- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00576914
Adjuvant Vinorelbine Plus Cisplatin (NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer
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)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Xinling Liu, Bachelor
- Phone Number: 86-10-87788495
- Email: liuxinling1985@126.com
Study Contact Backup
- Name: Fang Li, M.D.
- Phone Number: 86-13910145882
- Email: nc_lifang@yahoo.com.cn
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100021
- Recruiting
- The Lung Cancer Center of Cancer Hospital
-
Contact:
- Xinling Liu, Bachelor
- Phone Number: 86-10-87788495
- Email: liuxinling1985@126.com
-
Contact:
- Fang Li, M.D.
- Phone Number: 86-13910145882
- Email: nc_lifang@yahoo.com.cn
-
Sub-Investigator:
- Xiangru Zhang, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
vinorelbine plus cisplatin plus 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 Names:
|
No Intervention: B
vinorelbine plus cisplatin
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: five year
|
five year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
recurrence-free survival and the toxicity and safety of the regimens
Time Frame: 5 year
|
5 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Jie He, M.D. & Ph.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Endostatins
Other Study ID Numbers
- 2006 BAI02A02[1]-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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