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，旨在建立可耐受的 抗体C225的剂量在一系列剂量水平上施用， 对既往未经治疗的头部和 不能切除以达到治愈目的的颈癌。 患者将从癌症中心患者人群中招募 以及其他机构的转介。 主要研究评价 参数为安全性-当以下列剂量给药时，C225毒性的体征和症状 联合放疗。 将通过体格检查进行肿瘤缓解评价 周刊将通过放射学胶片进行肿瘤缓解评价 在治疗结束后。 最大耐受剂量定义为最高耐受剂量之前的剂量。 3 2例患者发生任何C225相关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 preceding the highest dose level at which 3 2 patients experience any C225 related grade 3 or grade 4 toxicity.