A phase I study of FLOT in metastatic gastric cancer

JRCT ID: jRCTs041200044

Registered date:16/09/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Gastric cancer
• Date of first enrollment: 26/10/2020
• Target sample size: 36
• Study type: Interventional

Intervention(s)

FLOT
docetaxel:30 or 40 or 50mg/m2 day1
oxaliplatin:85mg/m2 day1
levofolinate:200mg/m2 Day1
continuous infusional fluorouracil:2600mg/m2 Day1(24hours)

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Masuishi Toshiki