Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Intervention: C225 (cetuximab)
Intervention description: one week before and then weekly during radiotherapy
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: Radiotherapy; chemotherapy; Drug Targeting; loco-regionally advanced nasopharyngeal carcinoma; Safety.; efficacy

Summary:

      This is an open, multicenter phase Ⅱ clinical trial on cetuximab (C225) combined with IMRT +
      concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma.
    

Eligibility 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 according to UICC (International Union Against Cancer) 2002 6th
             edition criteria

          -  Primary tumor measurable

          -  KPS score ≥80

          -  Expected life span ≥6 months

          -  Adequate bone marrow function: White Blood
             Cell≥4×109/L，Hemoglobin≥100g/L，Platelet≥100×109/L

          -  Adequate liver function: ALAT/ASAT<1.5 × upper limit of normal (ULN), bilirubin
             <1.5×ULN

          -  Adequate renal function: Creatinine Clearance < 1.5×ULN

        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 β-HCG) or lactation period

          -  Severe intercurrent illness, e.g. uncontrolled hypertension, cardiac failure