Endostar Continuous Intravenous Infusion Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma.
This study was a multicenter, prospective, randomized controlled clinical trial. A set of unified standards were used, including the clinical research program, inclusion criteria, exclusion criteria, chemoradiotherapy regimen and evaluation criteria. A total of 73 patients with pathologically confirmed locoregionally advanced nasopharyngeal carcinoma would be enrolled. Patients were randomly divided into two groups, with 48 patients in the combination group and 25 patients in the control group. The combination group was treated with Induction and Concurrent Chemoradiotherapy combined with Endostar. The control group was treated with Induction and Concurrent Chemoradiotherapy. The short term efficacy and side effects of these treatments would be evaluated. The 1-year, 3-year progression-free survival and overall survival would be analyzed. This data of this study might provide an alternative option for the treatment of Locoregionally advanced nasopharyngeal carcinoma with higher efficacy and low toxicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
73
Endostar, 15 mg/m2, continous intravenous infusion, 3 cycles during induction chemotherapy, 4 cycles during concurrent chemoradiotherapy.
Cisplatin, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy; Cisplatin, 80 mg/m2, intravenous infusion, 2 cycles during concurrent chemoradiotherapy.
Docetaxel, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy.
progression-free survival (PFS)
Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause
Time frame: Approximately 36 months
objective response rate
Complete response (CR)+Partial response (PR) according to RECIST 1.1
Time frame: 18months
overall survival (OS)
Overall survival was defined as the time from randomization to death from any cause
Time frame: Approximately 36 months
adverse event (AE)
adverse event according to NCI-CTCAE (5.0)
Time frame: Approximately 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
IMRT: 66 Gy, 2-2.2 Gy per fraction, a total of 33 fractions