Phase I/II Clinical Trial of Recombinant Human Endostatin in Combination With Concurrent Chemo-Radiotherapy in the Patients With Unresectable Stage III Non-small-Cell Lung Cancer
Primary:To assess the treatment response rate (RR) of Endostar in combination with CCRT
- The progression-free survival (PFS)
- The overall survival(OS).
- The failed treatment modality.
- The toxicity of this regimen.
OUTLINE CCRT:Patients receive chemotherapy comprising Docetaxel(65mg/m2,iv gtt duration>1h)
and Cisplatin(65mg/m2,concurrent hydration) on days 1 and 29 and at least 3 hours after
chemotherapy undergo concurrent 3D-CRT five days a week for total dose 60-66Gy.
Endostatin:Patients receive Endostatin 7.5mg/m2 daily by iv gtt up to 7 days consecutively 1
week before radiotherapy and repeat every 2 weeks.
Patients are seen in follow-up every 3 months for 2 years and then every 6 months
thereafter. Physical examination and CT scans of the thorax and upper abdomen are performed
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate (RR)
Tumor response was evaluated with thoracic CT scans when CCRT was completed, in accordance with Response Evaluation Criteria in Solid Tumors Group (RECIST).
4 weeks after CCRT
Ming Chen, Doctor
Sun Yat-sen University
China: Food and Drug Administration