Cisplatin Chemoradiation With or Without Cetuximab for Locoregionally Advanced Squamous Cell Carcinomas (SCC) of the Head and Neck
Cisplatin Chemoradiation With or Without Cetuximab for Locoregionally Advanced Squamous Cell Carcinomas (SCC) of the Head and Neck
To examine the safety and toxicity of concurrent radiotherapy with cisplatin with the further
 addition of cetuximab experimental treatment
Conventional radiotherapy (65-70 Gy, 1.8 Gy per day) concurrently with weekly cisplatin
 (40mg/m2) (group A, n=25) or with weekly cisplatin (40mg/m2) and weekly cetuximab 250mg/m2,
 after initial dose of 400mg/m2) (group B, n=25) is applied (in a 1:1 randomization ratio).
 Groups will be matched age, sex, PS, and disease site.
Inclusion Criteria:

 -  histologically confirmed HNSCC of oral cavity, larynx, oropharynx or

 -  hypopharynx; age of 18 years or more

 -  adequate liver (SGOT, SGPT, ALP ≤ 3x normal)

 -  kidneys (creatinine clearance ≥ 60ml/min

 -  heart (no arrythmias, no heart failure) and

 -  bone marrow (WBC ≥ 4,000/μL, granulocytes ≥ 1,500/μL, Hb ≥ 10g/dL, platelets ≥
 100,000/μL) function

 -  ECOG performance status 0 or 1 and

 -  stage III or IVa to b with measurable lesions

 -  written informed consent

 Exclusion Criteria:

 -  prior radiotherapy

 -  chemotherapy

 -  concurrent active malignancies

 -  pregnancy

 -  breast-feeding