JPRN-jRCTs031180028进行中（未招募）2 期
JCOG1704:A phase II study of systemic chemotherapy with Docetaxel, Oxaliplatin, and S-1 followed by surgery in advanced gastric cancer with extensive lymph node metastasis - Bulky/PAN-GC DOS NAC Phase II
Doki Yuichiro0 个研究点目标入组 50 人开始时间: 2018年10月22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
- 50
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 <= 75age old（—）
- 性别
- All
入选标准
- •1) Histologically proven gastric adenocarcinoma
- •2) HER2 negative has to be confirmed
- •3) Enhanced abdominal CT revealed having any of the followings:
- •i) Paraaortic lymph node metastasis (No.16a2/ 16b1)
- •ii) Bulky lymph node (>=3cmx1 or >=1.5cmx2)
- •iii) Both of No.16a2/ 16b1 and Bulky lymph node
- •4) Enhanced thoracic/ abdominal/ pelvic CT revealed having no distant metastasis other than No.13 or No.16a2/ 16b1 lymph node metastasis
- •5) Neither Borrmann type 4 nor large (8cm or more) type 3
- •6) Length of esophageal invasion less or equal to 3cm
- •7) Not stump cancer of stomach
- •8) Clinically no sign of distant metastasis
- •9) Age between 20 and 75 at registration
- •10) Performance Status(ECOG) 0 or 1.
- •11) No peritoneal metastasis and CY0 by laparoscopy or laparotomy
- •12) Total gastrectomy with thoracotomy, left upper abdominal exenteration or Appleby's operation is not required to achieve the R0 resection
- •13) No prior treatment of chemotherapy or radiation therapy or endocrine therapy against any other malignancies
- •14) 1No prior surgery for gastric carcinoma except for bypass surgery and endoscopic resection
- •15) Fair oral intake with or without bypass surgery
- •16) Sufficient organ function.
- •i. Neutrophil >= 2,000/mm3
- •ii. Hb >= 8.0 g/dL
- •iii. Platelet >= 100,000/mm3
- •iv. T.Bil <= 1.5 mg/dL
- •v. AST <= 100 IU/L
- •vi. ALT <= 100 IU/L
- •vii. CCr >= 50mL/min/body
- •17) Written informed consent from patient.
排除标准
- •1) Synchronous or metachronous (within 5 years) malignancies.
- •2) Infectious disease requiring systemic treatment.
- •3) Body temperature of 38 degrees Celsius or higher.
- •4) During pregnancy, within 28 days of postparturition, or during lactation.
- •5) Severe mental disease.
- •6) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
- •7) Under treatment with flucytosine, phenytoin, or warfarin.
- •8) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration.
- •9) Poorly controlled valve disease, dilated or hypertrophic cardiomyopathy
- •10) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema based on chest CT
- •11) Poorly controlled diabetes
- •12) Poorly controlled hypertension
- •13) HBs antigen positive
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