JPRN-UMIN000002181已完成2 期
A phase II study to confirm the feasibility of S-1 plus CPT-11 as a post operative chemotherapy for the patients with advanced gastric cancer in stage IIIA and IIIB (OGSG 0801) - A phase II study to confirm the feasibility of S-1 plus CPT-11 as a post operative chemotherapy for the patients with advanced gastric cancer in stage IIIA and IIIB (OGSG 0801)
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)0 个研究点目标入组 53 人开始时间: 2009年7月10日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
研究概览
简要总结
A total of 42 patients (79.2%, 95% CI 65.9-82.9) tolerated the planned 4 cycles of treatment with S-1 and docetaxel, and 34 patients (64.2%, 95% CI 49.8-76.9) completed subsequent S-1 monotherapy for 1 year.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Ineligible criteria 1.A fresh bleeding on the digestive tract 2.Severe allergy against medicines or history of allergy 3.with active double cancer 4.with uncontrollable cavity fluid 5.with some infectious diseases and/or febrile condition 6.with brain metastases 7.with some disorders on ECG 8.with heart diseases such as congestive heart failure, symptomatic coronary dysfunction, uncontrollable arrhythmia, infarction/history of infarction 9.with liver cirrhosis and/or active hepatitis 10.with DM uncontrollable 11.with severe pulmonary diseases such as interstitial pneumonia,Pulmonary fibrosis 12.uncontrollable diarrhea 13.under intestinal paralysis or ileus 14.patients with psychological disorder who seems difficult to undergo treatment 15. under medication of ATAZANABIL 16. under continuous medication of steroids 17. with continuous medication of fluoro-pyrimidine, flusitosine, fenitoin,and/or Warfarin 18. pregnant and/or nursing women or patients who like to have children 19. patient who seems difficult to undergo protocol treatment
研究者
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