Randomized phase II study of oxaliplatin reintroduction and the biweekly XELOX in previously treated patients with metastatic colorectal cancer (ORION study) - Randomized phase II study of oxaliplatin reintroduction and the biweekly XELOX (ORION study)

PO Epidemiological and Clinical Research Information Network (ECRIN)0 个研究点目标入组 42 人开始时间: 2010年9月1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: 42

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: A total of 46 patients were enrolled in the trial-22 patients were randomly assigned to the Q3W group and 23 to the Q2W group. The median TTF was 3.4 months in both groups (hazard ratio [HR] 1.053; p = 0.880). The median PFS and OS were 3.3 and 9.2 months in the Q2W group and 4.3 and 12.1 months in the Q3W group, respectively (HR 1.15; p = 0.153 and 0.672; p = 0.836). The most common grade 3-4 AEs in the Q3W and Q2W groups were fatigue (27.3 vs 21.7), neuropathy (9.1 vs 0 %) and diarrhea (9.1 vs 0 %), respectively.

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) blood transfusion or administration of blood products or hemopoietic factors (e.g. G-CSF) within 7 days before enrollment. 2) a history of serious drug hypersensitivity or serious drug allergy. 3) Grade 3 or 4 sensory neuropathy. 4) PD within the previous 2 months during prior oxaliplatin-based therapy. 5) less than 3 weeks after administration of folic acid preparation in prior chemotherapy 6) active double cancer within the past 5 years 7) uncontrolled pleural effusion or ascites 8) pericardial effusion 9) clinically important infection or suspected infection in febrile patients. 10) brain metastasis 11) significant electrocardiographic abnormality 12) clinically significant heart disease 13) severe pulmonary disease 14) fresh gastrointestinal bleeding 15) diarrhea(watery) or diarrhea that interferes with daily activities for patients with a stoma. 16) bleeding or intestinal obstruction 17) central nervous system disorders 18) senile dementia 19) patients who are judged to be unsuitable for this trial due to clinically significant mental / psychological disease etc 20) uncontrolled diabetes or diabetic neuropathy. 21) women who are pregnant, lactating, or wish to become pregnant. 22) patients who are judged to be ineligible by principal investigator for any other reason.

研究者

发起方

PO Epidemiological and Clinical Research Information Network (ECRIN)

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