JPRN-jRCTs051180020已完成2 期
A phase II study of neoadjuvant chemotherapy with S-1 and oxaliplatin followed by surgery in cStage III advanced gastric cancer patients - A phase II study of neoadjuvant chemotherapy with S-1 and oxaliplatin followed by surgery in cStage III advanced gastric cancer patients
Hayata Keiji0 个研究点目标入组 14 人开始时间: 2018年12月28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
- 14
研究概览
简要总结
This study suggestedthat the preoperative SOX regimen wasa tolerable regimen, howeverthe target number of cases could not be accumulated and the results were not obtained with the reliability intended at the time of study planning.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •1) Histologically proven gastric
- •adenocarcinoma
- •2) Clinical Stage III gastric cancer. No peritoneal metastases corresponding to P1. No distant metastasis including liver metastasis or the paraaortic lymph node metastasis
- •3) Age between 20 and 80 years old
- •4) ECOG performance status of 0 or 1
- •5) No previous chemotherapy,radiation
- •therapy or surgery for gastric cancer
- •6) Adequate organ function
- •(1) WBC:>=3,000/mm3,<12,000/mm3
- •(2) Neutrophil:>=1,500/mm3
- •(3) Platelet:>=100,000/mm3
- •(4) Hemoglobin:>=9,0g/dL
- •(5)AST(GOT)/ALT(GPT):<=100 IU/L
- •(6)Total bilirubin:<=2,0mg/dL
- •(7)Serum creatinine:<=1,2mg
- •(8)Creatinine clearance:>=60 mL/min
- •7)Possible oral intake
- •8) Written informed consent from patient
排除标准
- •1) With active double or multiple cancers
- •2) Severe complications (such as intestinal paralysis, bowel obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrolled diabetes mellitus, uncontrolled hypertension, heart failure, renal failure, cirrhosis, hepatic failure)
- •3) With active infection
- •4) Positive HBs antigen or positive HCV
- •5) Continuous systemic steroid therapy
- •6) Severe diarrhea
- •7) Past history of severe hypersensitivity to drugs
- •8) Under treatment with flucytosine
- •9) Under treatment with warfarin
- •10) Pregnant women, or women with the
- •possibility of the pregnancy, Men who want let to pregnancy
- •11) Patients judged inappropriate for the study by the physicians
研究者
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