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，其设计用于确定在常规照射期间在一系列剂量水平上施用的抗体C225的耐受剂量，所述患者患有先前未经治疗的头颈癌，所述头颈癌出于治愈目的不可切除。患者将从癌症中心患者和其他机构转介的人群中招募。 主要研究评价参数是安全性-与放疗联合给药时C225毒性的体征和症状。将每周通过体格检查进行肿瘤缓解评价。 治疗完成后，将通过放射学胶片进行肿瘤缓解评价。最大耐受剂量定义为32例患者出现任何C225相关3级或4级毒性的最高剂量水平之前的剂量。

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.