Phase II study of oxaliplatin based regimen in relapsed colon cancer patients treated with oxaliplatin based adjuvant - INSPIRE study

Epidemiological and Clinical research Information Network (ECRIN)0 个研究点目标入组 50 人开始时间: 2013年8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: 50

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

The median PFS was 11.5 months 95% confidence interval CI 8.3 16.0, the median OS was 45.4 months 95% CI 37.4 NA, and the RR was 56.0% 95% CI 42.3 68.8. Adverse events of grade 3 that occurred in 5% of cases were neutropenia in 6 patients 12%, peripheral sensory neuropathy in 5 patients 10%, diarrhea in 4 patients 8%, hypertension in 4 patients 8%, anorexia in 3 patients 6% and allergic reactions in 3 patients 6%.

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

研究者

发起方

Epidemiological and Clinical research Information Network (ECRIN)

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