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临床试验/JPRN-UMIN000004440
JPRN-UMIN000004440已完成未知

A phase ll study to show the feasibility of six months continuous administration of Docetaxel+TS-1 for patients with Stage lllA/lllB gastric cancer after surgical resection (OGSG 1002) - A phase ll study to show the feasibility of six months continuous administration of Docetaxel+TS-1 for patients with Stage lllA/lllB gastric cancer after surgical resection (OGSG 1002)

Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)0 个研究点目标入组 62 人开始时间: 2010年11月1日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
62

研究概览

简要总结

The completion rate for eight cycles of S-1 plus docetaxel(DS) therapy was 77.4% [95% confidence interval (CI) 65.0-87.1%]. Subsequent S-1 monotherapy for 1 year was feasible in 71.0% (95% CI 58.1-81.8%) of patients.

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)Patients with double cancers (simultaneous or different time) Following cases are eligeble : 1.carcinoma in situ of cervical cancer and/or focal colon cancer in adenoma 2.small multiple cancers whose stages are lower than main cancer 3.double early cancers removed by EMR/EDS 2)patients who has contraindication to TS-1 3)patients who need Flucitosine,Fenitoin and/or Walfarin 4)patients who have a history of severe allergy against medicine in grade 3 or 4 5)patients who have a history of severe allergy against medicine including polysolvate 80 6)with interstitial pneumonia 7)with severe diseases(intestinal paralysis, ileus, uncontrollable DM, Cardiac failure, liver dysfunction) 8)with watery diarrhea 9)Females who are pregnent,nursing or possibility of pregnancy, or have a plan to have baby in future 10)Males who have a plan to have their own baby 11)with HIV (positive) or liver cirrhosis/active hepatitis 12)Edema which needs treatment 13)patients whom doctor in chief decides not to register to this study

研究者

发起方
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)

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