JPRN-jRCTs041200044进行中（未招募）1 期
A phase I study of 5-fluorouracil/ l-leucovorin and oxaliplatin combined with docetaxel (FLOT) as first-line treatment in metastatic gastric cancer
Masuishi Toshiki0 个研究点目标入组 36 人开始时间: 2020年9月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
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
- •General Cohort (Part 1)
- •1)Written informed consent
- •2)Between the ages of 20 and 75
- •3)Histologically confirmed adenocarcinoma
- •4)HER2 unanalyzable or negative in case of tested
- •5)Unresectable advanced or recurrent gastric cancer
- •6)Patients without symptomatic brain or spinal code metastasis or meningeal dissemination
- •7)No ascites or pleural effusion needed to be removed
- •8)Measurable or non-measurable disease
- •9)No previous chemotherapy for gastric cancer
- •10)No prior use of oxaliplatin
- •11)PS 0-1
- •12)Adequate organ function
- •SPM Cohort (Part 2)
- •1)Written informed consent
- •2)Between the ages of 20 and 75
- •3)Histologically confirmed adenocarcinoma
- •4)HER2 unanalyzable or negative in case of tested, or not tested
- •5)Unresectable advanced or recurrent gastric cancer
- •6)Unresectable or recurrent gastric cancer with peritoneal metastasis
- •7)Patients without symptomatic brain or spinal code metastasis or meningeal dissemination
- •8)No pleural effusion needed to be removed
- •9)Measurable or non-measurable disease
- •10)No previous chemotherapy for gastric cancer
- •11)No prior use of oxaliplatin
- •12)Patients' peritoneal metastasis status and PS meets one of the following
- •(1)Patients with PS 0-2 who have massive ascites or inadequate oral intake
- •(2)Patients with PS 0-1 who have massive ascites and inadequate oral intake
- •13)Adequate organ function
排除标准
- •General Cohort (Part 1)
- •1)Patients with synchronous or metachronous multiple primary cancer which should be treated
- •2)Patients with severe peritoneal metastasis
- •3)Patients with infection which should be treated
- •4)Psychiatric disease that is inappropriate for entry into this study
- •5)History of any medical condition as follows
- •(1)renal insufficiency
- •(2)liver insufficiency
- •(3)interstitial pneumonitis
- •(4)myocardial infarction within the last 6 months or unstable angina pectoris within the last 3 weeks
- •(5)HBs Ag: positive or HBV-DNA:positive
- •(6)Grade2 or more peripheral sensory neuropathy
- •(7)Severe complication which investigators judge
- •6) Have done surgery by any of the following before the study treatment
- •(1) Extensive surgical operation within 28 days before the study treatment
- •(2) Colostomy and trial laparotomy within 14 days before the study treatment
- •(3) staging laparoscopy within 7 days before the study treatment
- •7) Continuous systemic steroids or immunosuppresant
- •8) Severe hypersensitivity
- •9) A woman who is pregnant, nursing, or possibly pregnant, or not willing to contracept
- •10) Patients who investigators judge inappropriate
- •SPM Cohort (Part 2)
- •1) Patients with synchronous or metachronous multiple primary cancer
- •2) Patients with infection which should be treated
- •3) Psychiatric disease that is inappropriate for entry into this study
- •4) History of any medical condition as follows
- •(1)renal insufficiency
- •(2)liver insufficiency
- •(3)interstitial pneumonitis
- •(4)myocardial infarction within the last 6 months or unstable angina pectoris within the last 3 weeks
- •(5)HBs Ag: positive or HBV-DNA:positive
- •(6)Grade2 or more peripheral sensory neuropathy
- •(7)Severe complication which investigators judge
- •5) Have done surgery by any of the following before the study treatment
- •(1) Extensive surgical operation within 28 days before the study treatment
- •(2) Colostomy and trial laparotomy within 14 days before the study treatment
- •(3) staging laparoscopy within 7 days before the study treatment
- •6) Continuous systemic steroids or immunosuppresant
- •7) Severe hypersensitivity
- •8) A woman who is pregnant, nursing, or possibly pregnant, or not willing to contracept
- •9) Patients who investigators judge inappropriate
研究者
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