Multicenter Phase II Study of FOLFOX/XELOX and Erbitux as First Line Therapy in Patients with Wild Type KRAS/BRAF Metastatic Colorectal Cancer. - Multicenter Phase II Study of FOLFOX/XELOX and Erbitux with Wild Type KRAS/BRAF mCRC.

Epidemiological and Clinical research Information Network (ECRIN)0 个研究点目标入组 57 人开始时间: 2010年2月24日最近更新: 2023年10月17日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 57

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

Results: The response rates in the FOLFOX + Cmab (n = 37) and XELOX + Cmab (n = 25) groups were 64.9 % (24/37) and 72.0 % (18/25), respectively. The median PFS in the FOLFOX + Cmab and XELOX + Cmab groups was 13.1 months (95 % confidence interval [CI] 12.1-17.5) and 13.4 months (95 % CI 10.1-17.9), respectively. Neutropenia was the most frequent grade 3/4 adverse event in both groups (33.9 %), followed by anorexia, acneiform eruption, skin fissure and paronychia. A waterfall plot of tumor diameter showed prominent shrinkage of the tumors in 88.7 % of patients.

研究设计

研究类型: Interventional

入排标准

年龄范围: 20years-old 至 ot applicable（—）
性别: All

入选标准

未提供

排除标准

•(1)Severe bone marrow suppression (2)Severe infectious disease (3) Severe dysesthesia or sensory abnormality with functional disorder (4) History of psychiatric disorder, central nervous system disorder or cerebrovascular accident (5)Comorbidity or history of heart failure (6)Comorbidity or history of interstitial lung disease or pulmonary fibrosis (7) Radiotherapy to target lesion ( Perioperative Adjuvant Radiotherapy is eligible ) (8)History of severe allergy (9)Pregnant or lactating women or women of childbearing potential (10)Severe comorbidity (renal insufficiency, hepatic failure, hypertension, hypercalcemia etc) (11)Symptomatic brain metastasis (12)Simultaneous or metachronous double cancers (13)Any other cases who are regarded as inadequate for study enrollment by the investigator.

研究者

发起方

Epidemiological and Clinical research Information Network (ECRIN)

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