JPRN-jRCTs051210007进行中（未招募）2 期
Randomized controlled trial of the efficacy of supportive care during adjuvant chemotherapy in patients with gastric cancer - ACCORD
Motoori Masaaki0 个研究点目标入组 150 人开始时间: 2021年4月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
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. Patients with primary gastric cancer between the ages of 20 and 80 who underwent curative gastr
- •ectomy and scheduled to receive adjuvant chemotherapy with S1 or S1 plus docetaxel
- •2. PS(ECOG) 0-1
- •3. White blood cells > lower limit of normal (LLN) or 4000/mm3 and < 12000/mm3
- •4.Neutrophils >1500/mm3
- •5.Hemoglobin>8.0g/dL
- •6.Aspartate aminotransferase (glutamic-oxaloacetic transaminase) (AST(GOT)) and alanine aminotransferase (glutamic-pyruvic transaminase) (ALT(GPT)) <3.0 x upper limit of normal (ULN) of the study site
- •7.Total bilirubin <1.5mg/dL
- •8.Creatinine <1.2mg/dL
- •9.Creatinine clearance>60 mL/min
排除标准
- •1. Patients with a history of intestinal resection other than gastrectomy, hepatectomy, or pancreatic resection
- •2. Patients with simultaneous or metachronous cancer
- •3. Patients with serious postoperative complications
- •4. Patients with serious comorbidities, such as interstitial pneumonia, pulmonary fibrosis, uncontrolled diabetes, heart failure, renal failure, and liver cirrhosis
- •5. Patients receiving systemic administration of steroids
- •6. Patients taking flucytosine
- •7. Patients taking warfarin potassium
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