Gastric cancer
Conditions
Interventions
FLOT
docetaxel:30 or 40 or 50mg/m2 day1
oxaliplatin:85mg/m2 day1
levofolinate:200mg/m2 Day1
continuous infusional fluorouracil:2600mg/m2 Day1(24hours)
Sponsors
Masuishi Toshiki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| General cohort (Part 1) Number of Participants With Dose Limiting Toxicity (DLT) SPM cohort(Part 2) Number of Participants With Dose Limiting Toxicity (DLT) | — |
Secondary
| Measure | Time frame |
|---|---|
| General Cohort (Part 1) Adverse events Relative dose intensity Response rate Disease control rate Time to treatment failure Progression-free survival Duration of response Overall survival SPM Cohort (Part 2) Adverse events Relative dose intensity Response rate Disease control rate Time to treatment failure Progression-free survival Duration of response Overall survival Ascites response rate Ascites disease control rate Overall survival without abdominal paracentesis Rate of improvement of oral intake | — |
Contacts
Public ContactTakatsugu Ogata
Osaka International Cancer Institute
Outcome results
None listed