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临床试验/JPRN-C000000285
JPRN-C000000285已完成2 期

Searching research on senior citizen's gastric cancer on clinical effect and safety of TS-1 - Searching research on senior citizen's gastric cancer on clinical effect and safety of TS-1

The Tokyo cooperative Oncology Group0 个研究点目标入组 30 人开始时间: 2005年11月18日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
30

研究概览

简要总结

Thirty-three patients were enrolled. Pharmacokinetics of S-1 was studied in six patients, and the maximum plasma concentrations of respective metabolites after S-1 administration were found to be similar to those reported for younger cancer patients. The overall response rate in 33 patients was 21.2% (95% CI, 10.7-37.8%), and median progression-free survival was 3.9 months, with a median overall survival of 15.7 months. Frequently noted adverse events include leukopenia, neutropenia, anemia, anorexia, and fatigue. As for serious adverse events, relatively higher frequencies of anemia (9%) and anorexia (12%) of grade 3 severity were found, but there were no grade 4 episodes. Conclusions: The results suggest that S-1 monotherapy is safe and useful for elderly patients with unresectable advanced or recurrent gastric cancer when the dose is selected with caution, taking into account renal function.

研究设计

研究类型
Interventional

入排标准

年龄范围
75years-old 至 ot applicable(—)
性别
All

入选标准

  • 未提供

排除标准

  • 1.History of severe drug allergic reaction 2.Severe Bone marrow suppression,renal and liver function disturbance 3.Concomitant therapy with another anticancer drug or flucytocine 4.Marked pleural effusion or ascites 5.Symptomatic brain metastasis 6.Intestinal fresh hemorrhage 7.Active secondary cancer 8.Accompanied serious diseases 9.Severe Ischemic heart disease or Arrhythmia which requires treatment 10.Watery diarrhea 11.Decision as ineligible by principal investigator

研究者

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