JPRN-jRCTs051180195已完成2 期
Phase II study of neoadjuvant chemotherapy with S-1 plus Cisplatin plus Docetaxel for large type 3 or type 4 gastric cancer (OGSG1402) - OGSG1402
FUJITANI Kazumasa0 个研究点目标入组 48 人开始时间: 2019年3月26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
- 48
研究概览
简要总结
eoadjuvant therapy of TS-1+CCP+DTX against large Type 3 or Type 4 gastric cancer did not show good efficacy with R0 resection rate statistical significance at 0.391 which did not reach the commonly accepted cutoff of 0.05.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •1. Histologically proven adenocarcinoma of the stomach
- •2. Borrmann type 4 or large (larger than or equal to 8cm) type 3
- •3. No evidence of distant peritoneal metastasis,
- •No evidence of distant metastasis including liver or
- •para-aortic lymph node metastasis
- •4. No involvement of the esophagus with >3cm
- •5. Age of 20 - 75 years
- •6. Performance Status (ECOG) of 0 or 1
- •7. No prior chemotherapy or radiotherapy for any malignancy
- •No prior surgery for gastric cancer
- •8. Adequate organ function :
- •1) WBC : 4,000 /mm3 - 12,000 /mm3,
- •2) Neutrophil : more than or equal to 2,000 /mm3,
- •3) Platelet : more than or equal to 100,000 /mm3,
- •4) Hb : more than or equal to 8.0 g/dL,
- •5) AST(GOT), ALT(GPT) : less than or equal to 100 IU/L,
- •6) Total bilirubin : less than or equal to 1.5 mg/dL,
- •7) Ccr : more than or equal to 60 mL/min
- •9. Sufficient oral intake
- •10. Written informed consent
排除标准
- •1. Synchronous or metachronous malignancies
- •2. Severe drug hypersensitivity
- •3. Infection or suspected infection with fever
- •4. Pregnancy or lactation
- •5. Cardiac infarction within 6 months
- •6. Continuous administration of steroids
- •7. Continuous administration of Frucitocin or Phenytoin
- •8. Uncontrollable diarrhea
- •9. HBs Ag positive or HCV Ab positive
- •10. Any severe complications
研究者
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