JPRN-jRCTs051180186进行中（未招募）2 期
A phase II study of perioperative capecitabine plus Oxaliplatin(CapeOx) therapy for advanced gastric cancer with multiple lymph node metastases - OGSG 1701
SUGIMOTO Naotoshi0 个研究点目标入组 30 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
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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)Histologically proven gastric carcinoma by endoscopic detection
- •2)HER2 negative or unknown
- •3)With any lesion written below by upper abdominal enhanced CT:
- •1.Paraaortic node metastases (#16a2/16b1) larger than 10mm
- •2.Bulky lymph node metastases located at celiac axis, common hepatic artery, splenic artery and/or upper mesenteric vein which make a huge bulk larger than 3.0 cm and/or multiple
- •large bulks larger than 1.5 cm
- •3.Paraaortic and bulky metastatic nodes
- •4)Without any lesions written below by thoratic, upper abdominal and pelvic enhanced CT:
- •1.mediastinal node metastases
- •2.lung metastases
- •3.peritoneal metastases
- •4.liver metastases
- •5.pleural fluid and/or ascites
- •6.paraaortic nodes metastases (# 16a1 and/or #16b2)
- •7.Other distant nodes metastases and/or CY1
- •5) Not a large type 3 or type 4 gastric cancer
- •Large: the size of cancer is larger than 8 cm
- •6)Without esophageal invasion longer than 3 cm
- •7)Not a remnant gastric cancer
- •8)Without cervical nodes metastases and/or distant metastases
- •9)Age between 20 and 80 years old
- •10)An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- •11) Without any prior chemotherapy, radiation therapy and/or hormone therapy for the gastric cancer and/or any other cancers
- •12)Without prior surgical therapy except EMR/ESD and/or bypass
- •13) Patients can take food orally with /without bypass
- •14) With good functions of important organs by a data taken within 2 weeks
- •of registration
- •1.Neutrophil: =>1,500/mm3
- •2.Hemoglobin: =>8.0 g/dL without blood transfusion
- •3.Platelet: =>100,000/mm3
- •4.AST, ALT: =< 100 IU/L
- •5.T.bil.: =<2.0 mg/dL
- •6.Creatinine clearance: =>60 ml/min/body
- •CC by Cockcroft-Gault method is available:=>60mL/min
- •15) With written Informed Consent
排除标准
- •1)With active double cancers excluding carcinoma in situ and/or prior cancer cured with longer than 5 year interval period
- •2)Pregnant or nursing female
- •3)Male expecting pregnancy of partner
- •4)Impossible to register to the study due to a psychological disorder by physician in charge's decision
- •5)Under continuous steroids medication
- •6)Patients who receives systemic continuous administration of phenytoin or warfarin potassium
- •7)With neuropathy on peripheral motor and/or sensory nerves: -> glade 2 of CTCAE v4.0
- •8)With interstitial pneumonitis, pulmonary fibrosis and/or severe pulmonary emphysema
- •9)With active bacterial/fungal infectious disease (with a fever over 38 centigrade)
- •10)With a history of cardiac infarction and/or anxiety angina pectoris within 6 months
- •11)With uncontrollable blood hypertension
- •12)With uncontrollable DM
- •13)With uncontrollable Diarrhea
- •14)Positive HBs antigen
- •15)Severe complications
- •16)Any other patients whom the physician in charge of the study judges to be unsuitable
研究者
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