CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA

放化疗加 C225（西妥昔单抗）治疗晚期鳞状细胞癌

• 批准号: 7376331
• 负责人: ELLEN L ZAKRIS
• 金额: $ 0.21万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376331
• 关键词: CHEMORADIOTHERAPY; PLUS; C225; CETUXIMAB; ADVANCED

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 U.S. Approximately two thirds of these patients present with advanced disease (Stage III or IV). Successful nonoperative treatment strategies have advanced considerable 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 respectable 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 patient 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 surgery. The primary objective of this study is 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 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. The secondary objectives are to: 1) determine whether each of the treatment regimens can be delivered safely and successfully following surgical resection for advanced head and neck cancer, 2) estimate the locoregional control and overall survival rates for patients treated with each regimen and 3) examine the correlation estimate the locoregional control and overall survival rates for patients treated with each regimen and 3) examine the correlation between EGFR (total and phosphorylated), pMAPK, pAKT, Stat-3, Ki-67, COX-2 and cylin B1 expression with the ultimate treatment outcome.

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，每年大约有43，000例头颈部鳞状细胞癌确诊病例，其中约三分之二的患者患有晚期疾病（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，对于许多晚期但值得注意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。尽管进行了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），在确定性手术后局部疾病复发的患者中，该事件的频率增加。 本研究的主要目的是使用随机分配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。次要目标是：1）确定每种治疗方案是否可以在晚期头颈癌的手术切除后安全和成功地递送，2）估计用每种方案治疗的患者的局部控制率和总生存率，3）检查相关性，估计用每种方案治疗的患者的局部控制率和总生存率，检测EGFR（总的和磷酸化的）、pMAPK、pAKT、Stat-3、Ki-67、考克斯-2和cylin B1表达与最终治疗结果之间的相关性。