CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。在美国，每年诊断出大约43，000例头颈部鳞状细胞癌。这些患者中约有三分之二患有晚期疾病（III期或IV期）。近年来，通过改进强化放射分割方案和/或使用联合放化疗方法，成功的非手术治疗策略取得了相当大的进展。尽管如此，对于许多晚期但可切除的头颈部鳞状细胞癌患者，手术切除后进行术后放射治疗仍然是一种常见的治疗方法。尽管积极的手术和辅助放射治疗，许多患者仍然死于局部疾病复发。晚期头颈癌患者也可能发生远处转移（最常见于肺部），并且在确定性治疗后局部疾病复发的患者中，该事件的频率增加。已发表的报告表明，大约四分之一到三分之一的晚期头颈癌患者接受手术和术后放射治疗的经验局部疾病复发。减少这些复发率的努力主要集中在术后联合放化疗上。 主要目的：采用随机分配II期设计，评价两种使用EGFR抑制剂C225联合放化疗治疗高危头颈部术后患者的治疗方案。本试验旨在确定任一方案是否有足够的希望在随后的III期研究中继续进行。这一决定将主要基于相对于已完成的组间试验RTOG 9501中接受放化疗治疗的类似患者的RTOG数据库，无病生存期是否有所改善。 次要目的：1）确定每种治疗方案是否可以在晚期头颈癌手术切除后安全成功地实施。2)评估每种方案治疗患者的局部控制率和总生存率。3)检测EGFR（总的和磷酸化的）、pMAPK、pAKT、Stat-3、Ki-67、考克斯-2和细胞周期蛋白B1表达与最终治疗结果之间的相关性。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. There are approximately 43,000 cases of head and neck squamous cell carcinoma diagnosed annually in the United States. Approximately two thirds of these patients present with advanced disease (Stage III or IV). Successful nonoperative treatment strategies have advanced considerably over recent years through the refinement of intensified radiation fractionation schedules and/or the use of combination chemoradiation approaches. Nonetheless, for many patients with advanced but resectable squamous cell carcinoma of the head and neck, surgical resection followed by postoperative radiation therapy remains a common treatment approach. Despite aggressive surgery and adjuvant radiation, many patients still succumb to locoregional disease recurrence. Distant metastases (most commonly to the lungs) can also occur in advanced head and neck cancer patients, and the frequency of this event is increased in patients who suffer locoregional disease recurrence following definitive therapy. Published reports suggest that approximately one quarter to one third of advanced head and neck cancer patients treated with surgery and postoperative radiation therapy experience locoregional disease recurrence. Efforts to diminish these recurrence rates have focused primarily on combined chemoradiation in the postoperative setting. Primary Objective: To evaluate, using a random assignment phase II design, two treatment regimens that utilize the EGFR inhibitor C225 in combination with chemoradiation in high-risk postoperative head and neck patients. This trial is designed to determine if either regimen is promising enough to be pursued in a pursued in a subsequent phase III study. This decision will be primarily based on whether there is improvement in disease-free survival relative to the RTOG database of similar patients treated with chemoradiation in the completed intergroup trial RTOG 9501. Secondary Objective: 1) To determine whether each of the treatment regimens can be delivered safely and successfully following surgical resection for advanced head and neck cancer. 2) To estimate the locoregional control and overall survival rates for patients treated with the each regimen. 3) To examine the correlation between EGFR (total and phosphorylated), pMAPK, pAKT, Stat-3, Ki-67, COX-2, and cyclin B1 expression with the ultimate treatment outcome.