Recombinant Human Endostatin Combined With NP in Neoadjuvant Chemotherapy of Stage ⅢA NSCLC
Primary Purpose
Non Small Cell Lung Cancer
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Endostatin
Vinorelbine
Cisplatin
Sponsored by

About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring lung cancer Anti angiogenesis therapy survival
Eligibility Criteria
Inclusion Criteria:
- The pathology proved to be non small cell lung cancer (must be histologically).
- At present, the patients with ⅢA stage (N2) were evaluated by the assistant examination;
- The patients were evaluated by imaging, laboratory examination and other examination;
- Without chemotherapy or anti angiogenic therapy;
- There can be measured lesions
- Informed consent.
Exclusion Criteria:
- Pregnant, lactating women, or patients with fertility but did not take contraceptive measures.
- Severe infection.
- Severe heart disease.Neuropsychiatric disorders, which is not easy to control.
- Severe diabetes.
- There is obvious bleeding tendency.
- The 5 years history of other tumors
Sites / Locations
- Tianjin Medical University Cancer Institute and Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Endostatin plus NP
NP neoadjuvant chemotherapy
Arm Description
drug:Endostatins Intravenous drip, 7.5mg/m^2, d1-14 drug:vinorelbine Intravenous drip 25mg/m^2,IV, d1, d8; drug:Cisplatin,75mg/m^2 Intravenous drip,divide into d1-3 for 2 cycles
drug:vinorelbine Intravenous drip 25mg/m^2,IV, d1, d8; drug:Cisplatin,75mg/m^2 Intravenous drip,divide into d1-3 for 2 cycles
Outcomes
Primary Outcome Measures
Tumor Regression Rate
Target lesion size reduction ratio
Secondary Outcome Measures
Disease free survival is defined as the time from randomization to disease recurrence or death which comes first.
Overall Survival
the time from randomization to death.
Clinical Benefit Rate
Full Information
NCT ID
NCT02497118
First Posted
July 5, 2015
Last Updated
July 13, 2015
Sponsor
Tianjin Medical University Cancer Institute and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02497118
Brief Title
Recombinant Human Endostatin Combined With NP in Neoadjuvant Chemotherapy of Stage ⅢA NSCLC
Official Title
Clinical Study of Recombinant Human Endostatin Combined With NP Chemotherapy in the Treatment of Stage ⅢA Non Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study mainly to observe the anti angiogenic drugs Endostatin (Endostar) combined with vinorelbine and Cisplatin (NP) as neoadjuvant therapy in patients with non small cell lung cancer clinical efficiency and safety. Through anti angiogenesis therapy combined with neoadjuvant chemotherapy improve the treatment of neoadjuvant therapy in tumor response rate and the rate of resection, At the same time, the study before and after the anti angiogenesis therapy in patients with peripheral blood circulation endothelial cells(CECs), levels of Endothelial progenitor cells(EPC), micro vascular density(MVD) and vascular endothelial growth factor(VEGF) expression level, to understanding the correlation between the clinical efficacy of anti angiogenesis therapy combined with chemotherapy and the change of all these markers. In order to find the reference basis for the prediction of the effect of curative effect. The changes of blood volume, blood flow and vascular permeability of the lung cancer before and after treatment with CT perfusion imaging are studied.
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
lung cancer Anti angiogenesis therapy survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endostatin plus NP
Arm Type
Experimental
Arm Description
drug:Endostatins Intravenous drip, 7.5mg/m^2, d1-14 drug:vinorelbine Intravenous drip 25mg/m^2,IV, d1, d8; drug:Cisplatin,75mg/m^2 Intravenous drip,divide into d1-3 for 2 cycles
Arm Title
NP neoadjuvant chemotherapy
Arm Type
Active Comparator
Arm Description
drug:vinorelbine Intravenous drip 25mg/m^2,IV, d1, d8; drug:Cisplatin,75mg/m^2 Intravenous drip,divide into d1-3 for 2 cycles
Intervention Type
Drug
Intervention Name(s)
Endostatin
Other Intervention Name(s)
Endostar
Intervention Description
Endostatin,7.5mg/m^2,intravenous, d1-14;
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Intervention Description
vinorelbine,25mg/m^2,intravenous, d1, d8;
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin,75mg/m^2 intravenous,divide into d1-3
Primary Outcome Measure Information:
Title
Tumor Regression Rate
Description
Target lesion size reduction ratio
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Disease free survival is defined as the time from randomization to disease recurrence or death which comes first.
Time Frame
5 years
Title
Overall Survival
Description
the time from randomization to death.
Time Frame
5 years
Title
Clinical Benefit Rate
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The pathology proved to be non small cell lung cancer (must be histologically).
At present, the patients with ⅢA stage (N2) were evaluated by the assistant examination;
The patients were evaluated by imaging, laboratory examination and other examination;
Without chemotherapy or anti angiogenic therapy;
There can be measured lesions
Informed consent.
Exclusion Criteria:
Pregnant, lactating women, or patients with fertility but did not take contraceptive measures.
Severe infection.
Severe heart disease.Neuropsychiatric disorders, which is not easy to control.
Severe diabetes.
There is obvious bleeding tendency.
The 5 years history of other tumors
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
27566586
Citation
Zhao X, Su Y, You J, Gong L, Zhang Z, Wang M, Zhao Z, Zhang Z, Li X, Wang C. Combining antiangiogenic therapy with neoadjuvant chemotherapy increases treatment efficacy in stage IIIA (N2) non-small cell lung cancer without increasing adverse effects. Oncotarget. 2016 Sep 20;7(38):62619-62626. doi: 10.18632/oncotarget.11547.
Results Reference
derived
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Recombinant Human Endostatin Combined With NP in Neoadjuvant Chemotherapy of Stage ⅢA NSCLC
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