This is a Phase Ⅲ randomized, controlled, multi-center, trial comparing cisplatin plus docetaxel to cetuximab, cisplatin, and docetaxel induction chemotherapy followed by concurrent chemoradiation in previously untreated patients metastatic nasopharyngeal carcinoma (mNPC) to determine whether the addition of cetuximab to induction chemotherapy and chemoradiation could improve therapeutic efficacy in mNPC, and investigate predictive and prognostic factors for mNPC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
400 mg/m\^2 intravenously on day 1,then 250 mg/m\^2 intravenously every week of each 21 day cycle for 6 cycles of induction chemotherapy.250 mg/m\^2 intravenously every week concurrent with radiotherapy.
75mg/m\^2 intravenously on day 1 of each 21 day cycle for 6 cycles of induction chemotherapy.30 mg/m\^2 intravenously every week concurrent with radiotherapy.
75mg/m\^2 intravenously on day 1 of each 21 day cycle for 6 cycles of induction chemotherapy.
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGProgression-free survival
Progression-free survival was defined as the time from date of randomization until the date of first documented progression, date of death from any cause, or date of last assessment, whichever came first. All eligible and treated patients were included in the analysis.
Time frame: From date of randomization until the date of first documented progression, date of death from any cause, or date of last assessment, whichever came first, assessed up to 5 years
Event-free Survival
Event-free survival was defined as the time from date of randomization until the date of first documented progression, date of death from any cause, date of introduction of a new treatment without evidence of progression or relapse, or date of last assessment, whichever came first. All eligible and treated patients were included in the analysis.
Time frame: From date of randomization until the date of first documented progression, date of death from any cause, date of introduction of a new treatment, or date of last assessment, whichever came first, assessed up to 5 years.
Disease-free Survival
Disease-free survival was defined as the time from date of attainment a complete response until the date of first documented relapse, date of death from NPC or treatment-related toxicities, or date of last assessment, whichever came first. All eligible and treated patients were included in the analysis.
Time frame: From date of attainment a complete response until the date of first documented relapse, date of death from NPC or treatment-related toxicities, or date of last assessment, whichever came first, assessed up to 5 years.
Overall Survival
Overall survival was defined as the time from randomization until the date of death from any cause, or date of last assessment, whichever came first. All eligible and treated patients were included in the analysis.
Time frame: From date of randomization until the date of death from any cause, or date of last assessment, whichever came first, assessed up to 5 years.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1000mg/m\^2 orally twice a day, days 1 to 14 of each 21 day cycle for at least 2 years or until progression following concurrent chemoradiation.
60-66 Gy if complete response or 66-70 Gy if partial response following induction chemotherapy.
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGGuangxi Cancer Hospital
Nanning, Guangxi, China
RECRUITINGUnion Hospital,Tongji Medical College of Huazhong University of Science ＆ Technology
Wuhan, Hubei, China
RECRUITINGTongji Hospital,Tongji Medical College of Huazhong University of Science ＆ Technology
Wuhan, Hubei, China
RECRUITINGJiangsu Cancer Hospital
Nanjing, Jiangsu, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGSichuan Cancer Hospital
Chengdu, Sichuan, China
RECRUITINGZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGOverall response rate
Tumor response was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Overall response rate= complete response + partial response. Tumor measurements were performed using physical examination, computer tomography (CT) or Positron Emission Tomography-Computer Tomography (PET-CT) scans and Magnetic Resonance Imaging （MRI） scans, which were consist with baseline measurements methods.
Time frame: every 6 weeks, up to 5 years.