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
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