Cisplatin Plus Docetaxel Versus Cetuximab, Cisplatin, and Docetaxel in Metastatic Nasopharyngeal Carcinoma

Phase Ⅲ Randomized Trial of Cisplatin Plus Docetaxel Versus Cetuximab, Cisplatin, and Docetaxel Induction Chemotherapy Followed by Concurrent Chemoradiation in Previously Untreated Patients Metastatic Nasopharyngeal Carcinoma

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.

Inclusion Criteria:

• Histologically or cytologically confirmed nasopharyngeal carcinoma
• Untreated metastatic nasopharyngeal carcinoma (stage ⅣC according to the 7th American Joint Committee on Cancer staging system and stage ⅣB according to the Chinese 2008 staging system for nasopharyngeal carcinoma)
• Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy of at least 6 months
• Absolute neutrophil count (ANC) >=1.5×10^9/L
• Platelets >= 80×10^9/L
• Hemoglobin >= 90 g/l
• Bilirubin <= 1.5 × upper limit of normal (ULN)
• Aminopherases ( alanine transaminase and aspartate aminotransferase) <= 2.5 × ULN (without liver metastasis) or <= 5.0 × ULN (with liver metastasis)
• Creatinine <=ULN
• International normalized ratio (INR) of prothrombin time (PT) <= 1.5 × ULN
• The pregnancy tests of women of childbearing potential should be negative before treatment
• Women of childbearing potential and sexually active males must adopt efficient contraception methods while on treatment and for six months after the completion of the treatment
• Patients should understand and are willing to participate in the study. Inform consent form is supposed to obtained before treatment

Exclusion Criteria:

• Prior radiotherapy of target lesions
• Prior systemic chemotherapy and/or targeted therapy
• Brain metastasis
• Concurrent other malignancies
• Severe or active infectious disease requiring systemic antibiotics or antiviral, antifungal treatment
• Active tuberculosis
• Severe cardiovascular disease, including uncontrolled hypertension, unstable angina, myocardial infarction in the past 6 months, congestive heart failure with cardiac function grade Ⅲ to Ⅳ based on New York Heart Association cardiac functional grading, serious arrhythmia, or pericardial effusion
• Co-existing mental disease that would preclude full compliance with the study
• Females are pregnant or breast feeding