This study is aimed to investigate the short-term efficacy and toxicities of local advanced nasopharyngeal carcinoma (NPC) treated with TPF regimen induction chemotherapy combined with nimotuzumab concurrent radiotherapy and cisplatin concurrent chemoradiotherapy.
TPF program is currently the local advanced nasopharyngeal carcinoma commonly used inducing chemotherapy, cisplatin is the preferred drug for the same period chemotherapy, however, due to heavier gastrointestinal reactions caused by cisplatin, direct damage to renal parenchymal and other adverse reactions often lead to anti-tumor therapy can not be smooth Carried out, resulting in treatment failure, thus affecting the survival of patients.In this study, Phase II clinical trials were performed. Patients with locally advanced local advanced nasopharyngeal carcinoma were nonrandomly divided into experimental group and control group.The trial group was treated with TPF regimen induction chemotherapy combined with nimotuzumab concurrent radiotherapy and chemotherapy. The control group was treated with TPF regimen induction chemotherapy combined with Cisplatin concurrent radiotherapy and chemotherapy.observed and compared the efficacy and toxicity of the two treatment to assess its safety and patient tolerance.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
TPF Regimen Induction Chemotherapy combined with nimotuzumab concurrent radiotherapy concurrent chemoradiotherapy
TPF Regimen Induction Chemotherapy combined with cisplatin concurrent radiotherapy concurrent chemoradiotherapy
Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China
RECRUITINGNational Cancer Institute CTCAE v4.0
Acute toxicity of radiotherapy and chemotherapy
Time frame: 1 year
evaluation of immediate efficacy overall survival overall survival overall survival overall survival overall survival overall survival
Evaluation of efficacy by RESIST1.1 standard
Time frame: 1 year
overall survival
Evaluate the Overall survival after Concurrent chemo-radiotherapy by RECIST
Time frame: 5 years
locoregional failure-free survival
Evaluate the Overall survival after Concurrent chemo-radiotherapy by RECIST
Time frame: 5 years
progression-free survival
Evaluate the Overall survival after Concurrent chemo-radiotherapy by RECIST
Time frame: 5 years
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