Nasopharyngeal Carcinoma
Conditions
Interventions
1:cetuximab (C225) combined with IMRT + concurrent cisplatin
Sponsors
Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 69 Years
Inclusion criteria
Inclusion criteria: Informed consent form signed prior to study entry Age between 18-69 years old Pathology approved to be nasopharyngeal carcinoma (types WHO II-III) Stage III, IVa, IVb (M0) according to UICC 2002 6th edition criteria Primary tumor measurable KPS score >=80 Expected life span >=6 months Adequate bone marrow function: WBC>=4*10^9/L, Hb>=100g/L, PLT>=100*10^9/L Adequate liver function: ALAT/ASAT<1.5*ULN, bilirubin <1.5*ULN Adequate renal function: Creatinine Clearance <1.5*ULN.
Exclusion criteria
Exclusion criteria: Evidence of distant metastatic disease; Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy); Previous radiotherapy for the primary tumor or lymph nodes; Previous exposure to epidermal growth factor-targeted therapy; Prior chemotherapy or immunotherapy for the primary tumor; Other previous malignancy within 5 years, except non-melanoma skin cancer or pre-invasive carcinoma of the cervix; Any investigational agent prior to the 1st study medication; Participation in another clinical study within the 30 days prior to Inclusion in this study; Peripheral neuropathy > grade 1; Known grade 3 or 4 allergic reaction to any of the study treatment; History of severe pulmonary or cardiac disease; Creatinine Clearance < 30ml/min; Know drug abuse / alcohol abuse; Legal incapacity or limited legal capacity; Active systemic infection; Medical or psychiatric illness, which in the investigators' opinions, would not permit the subject to complete or fully and completely understand the risks and potential complications of the study; Concurrent chronic systemic immune therapy or hormone therapy not indicated in the study protocol; Pregnancy (confirmed by serum or urine beta-HCG) or lactation period; Severe intercurrent illness, e.g. uncontrolled hypertension, cardiac failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 month loco-regional control rat; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 year progression-free survival;survival time free of metastasis;3 and 5 year overall survival;safety of this combined modality;loco-regional control rate at year 1, 3, and 5; | — |
Countries
China
Contacts
Public ContactProf. Lu Tai-xiang, Prof. Lin Tong-yu
Outcome results
None listed