Induction and Concurrent Chemoradiotherapy With Cetuximab for Patients With Locally Advanced Nasopharyngeal Carcinoma
Inclusion Criteria:
- Signed written informed consent
- Inpatients or outpatients, 18-65 years of age
- Histologically confirmed, newly diagnosed locally advanced (UICC/AJCC stage III to
IVB) nasopharyngeal carcinoma requiring radiotherapy
- Evidence of unidimensional measurable disease as per RECIST criteria
- No systemic metastatic disease (M0)
- ECOG performance status of 0 or 1 at study entry
- Effective contraception
- White blood cell count ≥ 3,000/mm3 with neutrophils ≥1,500/mm3, platelet count
≥100,000/mm3, hemoglobin ≥ 5.6 mmol/L (9 g/dL)
- Total bilirubin ≤ 1.5x upper reference range
- AST & ALT ≤ 1.5x upper reference range
- Glomerular filtration rate > 60 ml/min
- Serum creatinine ≤ 1.25x upper reference range
Exclusion Criteria:
- Previous radiotherapy, chemotherapy, surgery (excluding diagnostic biopsy) or any
investigational drug for the NPC
- Concurrent chronic systemic immune therapy, targeted therapy, anti-VEGF therapy or
EGFR-pathway targeting therapy not indicated in this study protocol
- Known hypersensitivity reaction to any of the components of study treatments
- Pregnancy or lactation period
- Systemic metastatic disease
- Clinically relevant coronary artery disease, history of myocardial infarction in the
last 12 months, or high risk of uncontrolled arrhythmia
- Peripheral neuropathy > grade 1
- Previous malignancy except basal cell cancer of the skin or preinvasive cancer of the
cervix
- Known alcohol or drug abuse
- Medical or psychological conditions that would not permit the patient to complete the
study or sign informed consent
- Legal incapacity or limited legal capacity