A PHASE III TRIAL OF CONCURRENT RADIATION AND CHEMOTHERAPY FOR HEAD/NECK CANCER

头颈癌同步放疗和化疗的 III 期试验

• 批准号: 7376283
• 负责人: ELLEN L ZAKRIS
• 金额: $ 0.41万
• 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/7376283
• 关键词: PHASE; III; TRIAL; CONCURRENT; RADIATION

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. The objectives of this study are to: 1) determine whether intensification of radiation, relative to conventional fractionation plus cisplatin in the combined therapy setting can further improve the overall survival of patients with advanced HNSCC; 2) assess the actuarial local-regional control and disease-free rates of patients treated with the different regimens; 3) define the acute and late toxicity of each treatment regimen; 4) evaluate whether there are differences in patient's QOL, perception of side effects and and performance status between treatment arms; and 5) establish whether EGFR and COX-2 expressions are independent prognostic markers for patients receiving concurrent chemoradiation. Approximately 480 males and females age 18 years or older will take part in this study. Patients will be randomized to one of two study arms. Patients in arm 1 will receive radiation once daily, Monday through Friday, for seven weeks, as well as Cisplatin IV on days 1, 22, and 43 or radiotherapy. Patients in arm 2 will receive radiation once daily, Monday through Friday, for 3.5 weeks then twice a day, Monday through Friday, for 2.5 weeks. Cisplatin will also be administered on days 1 and 22 of radiotherapy. Follow-up will be conducted at 4 weeks, 3 months, 6 months, 12 months, then every 3 months for 1 year, every six months for 3 years and then annually for life. These visits will include physical examination/history, tumor assessment if clinically indicated, CT/MRI of tumor if indicated, and completion of "Quality of Life" forms annually for years 2-5.

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。本研究的目的是：1）确定在联合治疗环境中，相对于常规分割加顺铂，强化放疗是否可以进一步提高晚期HNSCC患者的总生存率; 2）评估不同治疗方案治疗患者的精确局部区域控制率和无病率; 3）确定每种治疗方案的急性和晚期毒性; 4）评估治疗组之间患者的QOL、副作用感知和体能状态是否存在差异;和5）确定EGFR和考克斯-2表达是否是接受同时放化疗的患者的独立预后标志物。约480名18岁或以上的男性和女性将参加本研究。患者将被随机分配至两个研究组之一。第1组的患者将接受放射治疗，周一至周五，每天一次，持续7周，以及第1、22和43天的顺铂IV或放射治疗。第2组的患者将在周一至周五每天接受一次放疗，持续3.5周，然后在周一至周五每天接受两次放疗，持续2.5周。顺铂也将在放疗的第1天和第22天给药。随访将在4周、3个月、6个月、12个月进行，然后每3个月随访一次，持续1年，每6个月随访一次，持续3年，然后终身每年随访一次。这些访视将包括体格检查/病史、肿瘤评估（如有临床指征）、肿瘤CT/MRI（如有指征）以及填写“生活质量”表（每年一次，持续2-5年）。