Phase II study of oxaliplatin reintroduction treated with biweekly S-1 plus oxaliplatin (SOX) in patients with metastatic colorectal cancer.(ORION2) - ORION2

Epidemiological and Clinical research Information Network (ECRIN)0 个研究点目标入组 40 人开始时间: 2014年3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: 40

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

Biweekly S-1 plus oxaliplatin (SOX) reintroduction in previously treated metastatic colorectal cancer patients (ORION 2 study): a phase II study to evaluate the efficacy and safety. Hiroaki Tanioka. et al; Int J Clin Oncol. 2019 Feb 18. [Epub ahead of print] RESULTS: A total of 41 patients from 12 institutes were enrolled. The median PFS and OS survival were 3.3 months (95% confidence interval [CI] 2.7-4.2) and 10.1 months (8.3-14.6), and response rate and disease control rate were 10.0% and 65.0%, respectively. Grade 3 AEs included thrombocytopenia (5.0%), anorexia (5.0%), pneumonia (5.0%) and fatigue (5.0%). There were no cases of grade 4 AEs or treatment-related death.

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) Serious sensory abnormality or dysfunction 2) PD within 2 months during previous oxaliplatin-based therapy 3) Serious drug allergy 4) Presence of other active malignancies or a history of malignancies within the past 5 years 5) Blood transfusion or hemopoietic factors (G-CSF) within 7 days 6) Uncontrolled pleural effusion, ascites, or pericardial effusion 7) Clinically significant infection 8) Brain metastasis 9) Clinically significant heart disease (myocardial infarction within 12 months, etc) 10) Serious complication(intestinal obstruction, interstitial pneumonia, uncontrolled diabetes, peptic ulcer hypertension, renal failure, hepatic failure) 11) Fresh GI bleeding 12) Watery diarrhea 13) Central nervous system disorders 14) Dementia or clinically significant mental/neurological disorders 15) Patients who need flucytosine, phenytoin or warfarin potassium 16) Women who are pregnant, lactating, or wish to become pregnant 17) Investigator's judgement

研究者

发起方

Epidemiological and Clinical research Information Network (ECRIN)

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