HNSCC: This phase III trial is trying to determine the effect of adding nimotuzumab to standard chemoradiotherapy treatment in patients with stage III/IV squamous cell carcinoma of the head and neck (SCCHN)Phase III, double-blind, placebo-controlled study of post-operative adjuvant concurrent chemo-radiotherapy with or without nimotuzumab for stage III/IV head and neck squamous cell cancer

Inclusion

• Age should be greater than or equal to the minimum age of consent in the applicable country
• Histologically proven head and neck squamous cell cancer (excluding nasopharynx, salivary glands, paranasal sinuses and unknown primaries) on biopsy of the primary lesion or the neck mass.
• Resectable stage III/IV according to the AJCC/UICC staging system with no evidence of distant metastasis.
• Complete macroscopic resection.
• Patients should have at least one of the following pathological features for inclusion: pT3 or pT4 and any nodal stage (N), except T3N0 of the larynx, with negative resection margins, or a tumor stage of 1 or 2 with a nodal stage of 2 or 3 and no distant metastasis (M0); patients with stage T1 or T2 and N0 or N1 who had unfavorable pathological findings (extranodal spread, positive resection margins, perineural involvement, or vascular tumor embolism) are also eligible, as are those with oral-cavity or oropharyngeal tumors with involved lymph nodes at level IV or V.
• Performance status must be ECOG 0 or 1. Patients should be able to tolerate chemotherapy and radiotherapy.

• Adequate bone marrow, renal and hepatic function:

  1. WBC>3000/mm3, platelets>100000/mm3
  2. Serum creatinine<upper limit of normal range as per institution and calculated creatinine clearance (according to the Cockcroft and Gault method) >50 ml/min.
  3. SAP, SGOT<2 x upper limit of normal range, bilirubin <1.5 x upper limit of normal range.
• Written informed consent.