Recombinant Human Endostatin Continued Pumping Into Vein Combining With CCRT in Unresectable Stage III NSCLC
|ClinicalTrials.gov Identifier: NCT01733589|
Recruitment Status : Completed
First Posted : November 27, 2012
Last Update Posted : July 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stage III Non-small-Cell Lung Cancer||Drug: Recombinant human endostatin Drug: Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cycles Drug: cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cycles Other: laboratory biomarker analysis Other: CT perfusion imaging||Phase 1 Phase 2|
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).
Measure changes in VEGF and other angiogenic cytokines and antiangiogenic factors in plasma samples from these patients.
Evaluate the application of CT perfusion imaging to determine changes in tumor vascular mophology and function during treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Phase I/II Clinical Trial of Recombinant Human Endostatin Continued Pumping Into Vein Combining With Concurrent Chemo-Radiotherapy in the Patients With Unresectable Stage III Non-small-Cell Lung Cancer|
|Actual Study Start Date :||November 2012|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Experimental: Recombinant Human Endostatin
All patients received recombinant human endostatin(7.5mg/m2/24h) Continued Pumping Into Vein through 5 days at week 1, 3, 5, and 7. During week 2 through 8, patients received etoposide 50mg/m2 days 1-5 and cisplatin 50mg/m2 on day 1,8, every 4 weeks for two cycles with concurrent thoracic radiation at 60~66Gy in 30~33 fractions for 6~7 weeks.
Drug: Recombinant human endostatin
Recombinant human endostatin(7.5mg/m2/24h) Continued Pumping Into Vein through 5 days at week 1, 3, 5, and 7,combined with concurrent chemo-radiotherapy.Drug: Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cycles Drug: cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cycles Other: laboratory biomarker analysis Other: CT perfusion imaging
- progression-free survival [ Time Frame: 2-year ]from beginning treatment to progressive disease or the last follow-up
- Response rate [ Time Frame: 1 month ]complete response(CR); partial response(PR); stable disease(SD); progressive disease(PD)
- overall survival [ Time Frame: 5 years ]from date of beginning treatment until date of death
- treatment related toxicities [ Time Frame: 3 months ]radiation-induced esophagitis; radiation-induced pneumonia
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733589
|Zhejiang Cancer Hospital|
|Hangzhou, Zhejiang, China, 310022|
|Principal Investigator:||Ming Chen, M.D.||Zhejiang Cancer Hospital|