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

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 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 研究中心，而研究中心不一定是研究者的研究机构。 这是一项在III期结肠癌根治性切除术后患者中比较FOLFOX与FOLFOX+西妥昔单抗的随机III期试验。 这是一项于2004年2月启动的ECOG研究，是一项更复杂的6组研究。 此后，该试验被缩减为两组，其他研究表明，这两组仍有可能产生有价值的信息。 西妥昔单抗（爱必妥，C225）是一种活性药物，已被证明是有效的，作为一个单一的药物，并与化疗联合治疗晚期复发性结肠癌患者。 它于2004年2月被批准用于治疗结肠癌。 西妥昔单抗是一种单克隆抗体，靶向并抑制表皮生长因子受体（EGFr），已发现该受体在超过35%的实体恶性肿瘤中过度表达。 本研究的目的包括评价FOLFOX +西妥昔单抗预防疾病复发的有效性，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（日常生活和整体健康感觉的变化），对生活习惯之间任何相互作用的评估，药物使用或饮食模式以及肿瘤内所含的分子标志物，并研究饮食习惯是否影响疾病复发的机会。 将获得组织和血液标本，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（标准治疗）与相同的药物加西妥昔单抗。

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.