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

• Determine safety and toxicity of combination [ Time Frame: Time from first administration of trial treatment to death or last date known to be alive, anticipated average time frame 24 months ] [ Designated as safety issue: Yes ]
  Toxicity is graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events version 1 system.
  
  

• Overall survival time [ Time Frame: Time from first administration of trial treatment to death or last date known to be alive, anticipated average time frame 24 months ] [ Designated as safety issue: Yes ]
  Time from first administration of trial treatment to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
  
  
• Progression-free survival time [ Time Frame: Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months ] [ Designated as safety issue: Yes ]
  Duration from first administration of trial treatment until progression (radiological or clinical, if radiological progression is not available) or death due to any cause. Patients without event are censored on the date of last tumor assessment.
  
  
• Response [ Time Frame: Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months ] [ Designated as safety issue: Yes ]
  Complete response (CR) is defined as the total disappearance of radiographic evidence of tumour. Partial response (PR) is defined as the ≥50% reduction in the product of the maximal bidimensional tumour diameters. Stable disease defined any change between +25% and -50% in tumour size, and progressive disease included any increase >25% from baseline or the appearance of any new lesion. We record tumour shrinkage and time to the development of disease progression according to the revised RECIST criteria, v.1.1.
  
  

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.