Spots Global Cancer Trial Database for Curative Effect Study of Endostatin Combined With Chemoradiotherapy to Non-small-cell Lung Cancer

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Trial Identification

Brief Title: Curative Effect Study of Endostatin Combined With Chemoradiotherapy to Non-small-cell Lung Cancer

Official Title: 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

Study ID: NCT01218594

Conditions

Non-small Cell Lung Cancer

Interventions

Endostatin

Study Description

Brief Summary: To evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy (CCRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC).

Detailed Description: OBJECTIVES: Primary:To assess the treatment response rate (RR) of Endostar in combination with CCRT Secondary * 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 routinely.