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临床试验/JPRN-UMIN000004443
JPRN-UMIN000004443已完成4 期

A tolerability study in Japan of Oxaliplatin, fluorouracil, and l-leucovorin for patients with stage II/III colon cancer - A tolerability study in Japan of OxaliplatIN, fluorouracil, and l-leucovorin for patients with stage II/III colon cancer(JFMC41-1001-C2: JOIN Trial)

Japanese Foundation for Multidisciplinary Treatment of Cancer0 个研究点目标入组 882 人开始时间: 2010年11月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
882

研究概览

简要总结

The PSN for >=8 days and the incidence of Gr.>=3 AR were 3.3% and 1.7%, respectively. At the onset of PSN, the median total dose of L-OHP and the median number of courses were 672.5mg/m2 and 9, respectively, while the corresponding values were 565.1mg/m2 and 7.5 at the onset of Gr.>=3 AR. Gr.3PSN appeared to gradually recover from 5.8% to 1.1%, 0.5%, and 0.2% at 12mths, 24mths and 36mths after enrollment, respectively. However, Gr.1 or Gr.2 PSNs after 3yrs follow-up were observed in 21.0% 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) Women who are pregnant or breast-feeding. 2) Women who are planning to become pregnant. 3) Appendix cancer. 4) Patients with a history of malignancy. 5) Participating in another clinical trial within 30 days. 6) Peripheral sensory neuropathy >= Grade 1. 7) Insulin-treated diabetic patients. 8) Uncontrolled congestive heart failure, angina pectoris, hypertension, and arrhythmia. 9) Patients with a history of significant neurological or mental illness. 10) Active infectious disease. 11) Other patients who are unfit for the study as determined by the attending physician.

研究者

发起方
Japanese Foundation for Multidisciplinary Treatment of Cancer

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