JPRN-UMIN000002797已完成2 期
Phase II study of the combination of Oxaliplatin and 5FU(mFOLFOX6) in patients with unresectable advanced/recurrent small intestinal cancer - Phase II study of mFOLFOX6 in patients with unresectable advanced/recurrent small intestinal cancer
Graduate School of Medicine, Kyoto University0 个研究点目标入组 35 人开始时间: 2009年11月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
研究概览
简要总结
Between April 2010 and November 2012, 24 patients were enrolled from 12 institutions. Median age: 63 years old (range, 31–79); male/female ratio: 18/6; PS 0: 17 (71%); PS 1: 7 (29%); locally advanced/metastatic disease: 2/22; primary tumor site: duodenum (58%) and jejunum (42%). The median follow-up time was 14.7 months (3.7-40.3). The 1-year PFS was 23.3%. The ORR was 45% (9/20). The median PFS and OS were 5.9 months (95% CI, 3.0–10.2) and 17.3 months (95% CI, 11.7–19.0), respectively. The common grade 3 or 4 toxicities were neutropenia (38%), anemia/peripheral neuropathy (25%), stricture (17%), fatigue/anorexia/bilirubin increase (8%), and diarrhea (4%). There were no treatment-related deaths.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 80years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Active other malignancies 2. Without assessable lesions 3. Active infectious disease 4. Peripheral neuropathy 5. Active Hemorrhage/bleeding 6. Uncontrollable watery diarrhea 7. Brain metastasis 8. Transfusion or blood product or growth factor such as G-CSF less than 7 days prior to entry 9. HBV carrier 10. Severe complications(ileus, interstitial pneumonitis, pulmonary fibrosis, uncontrollable diabetes mellitus, heart failure) 11. Pregnant or lactating woman 12. Severe psychological disease 13. Systemic steroid administration 14. Phenytoin, Warfarin potassium, or flucytosin administration 15. Not appropriate for the study at the physician's assessmnt
研究者
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