ECOG N0147: OXAL PLUS 5-FU/CF W/WO CETUXIMAB IN STAGE III COLON CANCERECOG N0

ECOG N0147：OXAL PLUS 5-FU/CF W/WO 西妥昔单抗治疗 III 期结肠癌RECOG N0

• 批准号: 7605775
• 负责人: HOWARD S HOCHSTER
• 金额: $ 0.95万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605775
• 关键词: Adverse effects; Affect; Biological Markers; Blood specimen; Caring; Cetuximab; Colon; Colon Carcinoma; Complex; Computer Retrieval of Information on Scientific Projects Database; Daily; Diet Habits; Disease; Drug Combinations; Eastern Cooperative Oncology Group; Effectiveness; Epidermal Growth Factor Receptor; Erbitux; Evaluation; Excision; Feeling; Fluorouracil; Fluorouracil/Leucovorin Calcium/Oxaliplatin; Funding; Genus Cola; Goals; Grant; Habits; Health; Institution; Leucovorin; Life Style; Malignant Neoplasms; Monoclonal Antibodies; Monoclonal Antibody C225; Patients; Pattern; Pharmaceutical Preparations; Phase III Clinical Trials; Quality of life; Randomized; Recurrence; Research; Research Personnel; Resources; Solid; Source; Staging; Standards of Weights and Measures; Tissues; United States National Institutes of Health; Upper arm; chemotherapy; oxaliplatin; prevent; response; treatment effect; tumor

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. This is a randomized Phase III trial of FOLFOX vs. FOLFOX plus Cetuximab in patients after curative resection with stage III colon cancer. This is an ECOG study that was activated in February 2004 as a more complex 6-arm study. The trial has since been trimmed down to the two arms that other research has shown to still have the likelihood to yield valuable information. Cetuximab (Erbitux, C225) is an active agent and has proven efficacious as a single agent and in combination with chemotherapy for patients with advanced recurrent colon cancer. It was approved for the treatment of colon cancer in February 2004. Cetuximab is a monoclonal antibody that targets and inhibits epidermal growth factor receptor (EGFr) that has been found to be over-expressed in more than 35% of all solid malignant tumors. The goals of the study include an evaluation of the effectiveness of FOLFOX + Cetuximab in preventing disease recurrence, a comparison of the side effects in the two groups of patients in the study, a comparison of the effects of treatment on quality of life (changes to daily routines and feelings of overall health), an evaluation of any interaction between lifestyle habits, medication use or dietary patterns and the molecular markers contained within the tumor and to study whether eating habits affect the chances of disease recurrence. Tissue and blood specimens will be obtained to search for markers for treatment response. The drug combinations being studied are oxaliplatin, 5-fluorouracil and leucovorin (standard of care) versus the same drugs plus Cetuximab.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项对III期结肠癌根治性切除患者进行的FOLFOX与FOLFOX加西妥昔单抗的随机III期试验。这是经社理事会的一项研究，于2004年2月启动，是一项更复杂的6臂研究。自那以后，这项试验已经缩减到了两个方面，其他研究表明，这些方面仍然有可能提供有价值的信息。西妥昔单抗(Erbitux，C225)是一种活性药物，已被证明作为单一药物和联合化疗对晚期复发性结肠癌患者有效。它于2004年2月被批准用于治疗结肠癌。西妥昔单抗是一种针对和抑制表皮生长因子受体(EGFR)的单抗，已发现超过35%的实体恶性肿瘤中EGFR过度表达。这项研究的目标包括评估FOLFOX+西妥昔单抗在预防疾病复发方面的有效性，比较研究中两组患者的副作用，比较治疗对生活质量的影响(改变日常生活方式和整体健康感觉)，评估生活习惯、用药或饮食模式与肿瘤内包含的分子标志物之间的任何相互作用，以及研究饮食习惯是否影响疾病复发的机会。将获得组织和血液样本，以寻找治疗反应的标志物。正在研究的药物组合是奥沙利铂、5-氟尿嘧啶和亚叶酸钙(标准护理)与相同药物加西妥昔单抗。