Cisplatin Chemoradiation With or Without Cetuximab for Locoregionally Advanced Squamous Cell Carcinomas (SCC) of the Head and Neck

Phase II Safety and Toxicity Study of Cisplatin With or Without Cetuximab and Concomitant Radiotherapy for Locoregionally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)

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