Study of Endostar Combined With Docetaxel and Cisplatin on the Angiogenesis of Advanced Non-small Cell Lung Cancer
To study the impact of endostar combined with docetaxel and cisplatin on the angiogenesis of
non-small cell lung cancer,patients will be randomly assigned to the experimental
group(endostar combined with docetaxel and cisplatin) and the control group (docetaxel and
cisplatin).
- the serum concentrations of Endostatin,VEGF and bFGF are determined.
- Blood circulating endothelial cells (CECs) and circulating hematopoietic progenitor
cells (CPCs) will be measured by flow cytometer.
- the clinical parameters such as objective response rate (ORT),time to progression(TTP)
and mean survival time(MST) will be collected according to the WHO criteria.
- the toxicity will be recorded according to the NCI-CTC v3.0.
- the Quality of life was self-assessed using the European Organisation for Research and
Treatment of Cancer (EORTC) QLQ C-30 questionnaire.
- Statistical analysis will be applied to study the relationship between the levels of
Endostatin,VEGF,bFGF,CECs and CPCs and the clinical outcomes such as ORT, TTP, MST,
toxicity and QOL.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
mean survival time
1 year
No
Changgui Wu, MD, PHD
Principal Investigator
Dept. Resp. Diseases, Xijing Hospital
China: Food and Drug Administration
XJ-EnXS0802
NCT00657423
April 2008
April 2009
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