To investigate the safety and efficacy recombinant human endostatin(endostar) durative transfusion combined with cocurrent chemoradiotherapy in advanced non-small cell lung cancer(NSCLC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
318
Chemotherapy: Cisplatin (50 mg/m2) on days 1, 8, 29, and 36 and etoposide (50mg/m2) on days 1~5 and 29~33. Radiotherapy: Thoracic radiotherapy (TRT) started with a linear accelerator (6MV-X) on the first day of chemotherapy.A minimum dose of 60 Gy (2 Gy per fraction, Monday~Friday) was delivered, and a range of 60-66 Gy in 2 Gy fractions was allowed.
Endostar(15mg/m2) was durative transfused during the normalization window of the first chemoradiotherapy cycle(days -5~-1).
Endostar(15mg/m2) was durative transfused during the normalization window of the first and the second chemoradiotherapy cycles(days -5~-1 and 24~28).
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China
progression free survival (PFS)
Evaluate the effect of chemoradiotherapy with or without recombinant human endostatin on progression free survival
Time frame: 4 years
Overall Survival(OS)
comparison to maintenance chemoradiotherapy alone
Time frame: 4 years
Treatment-related toxicity
Toxicity and adverse events related to the inventions
Time frame: 4 years
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