Non Small Cell Lung Cancer
Conditions
Keywords
lung cancer Anti angiogenesis therapy survival
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.
Interventions
DRUGEndostatin
Endostatin,7.5mg/m\^2,intravenous, d1-14;
DRUGVinorelbine
vinorelbine,25mg/m\^2,intravenous, d1, d8;
DRUGCisplatin
Cisplatin，75mg/m\^2 intravenous,divide into d1-3
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Regression Rate | 3 months | Target lesion size reduction ratio |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival is defined as the time from randomization to disease recurrence or death which comes first. | 5 years | — |
| Overall Survival | 5 years | the time from randomization to death. |
| Clinical Benefit Rate | 3 months | — |
Countries
China
Outcome results
None listed