EGFR ANTIBODY C225 WITH IRRADIATION IN ADVANCED HEAD & NECK SQUAMOUS CELL CANCER

这是一项单中心开放标签研究，旨在确定抗体C225在常规照射期间的耐受剂量范围，用于先前未经治疗的头颈癌患者，该患者无法切除治疗。患者将从癌症中心的患者和其他机构的转诊患者中招募。主要的研究评价参数是安全性- C225与放疗联合使用时的毒性体征和症状。每周进行体检评估肿瘤反应。治疗结束后进行x线片肿瘤反应评价。最大耐受剂量定义为在最高剂量水平之前的剂量，在最高剂量水平下，32名患者出现任何与C225相关的3级或4级毒性。

This is a single center open label study designed to establish a tolerable dose of Antibody C225 administered over a range of dose levels during conventional irradiation in previously untreated patients with head and neck cancer that is not resectable for curative intent. Patients will be recruited from the population of cancer center patients and referrals from other institutions. The primary study evaluation parameter is safety - signs and symptoms of C225 toxicity when given in combination with radiotherapy. Tumor response evaluation by physical examination will be conducted weekly. Tumor response evaluation by radiographic film will be conducted after the completion of the therapy. The maximum tolerated dose is defined as the dose preceeding the highest dose level at which 3 2 patients experience any C225 relatd grade 3 or grade 4 toxicity.