UMIN-CTR Clinical Trial

Basic information
Public title	Phase I study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 and intraperitoneal infusion of nafamostat mesilate for gastric cancer with peritoneal dissemination
Acronym	Phase I study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 and intraperitoneal infusion of nafamostat mesilate for gastric cancer with peritoneal dissemination
Scientific Title	Phase I study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 and intraperitoneal infusion of nafamostat mesilate for gastric cancer with peritoneal dissemination
Scientific Title:Acronym	Phase I study of weekly intravenous and intraperitoneal paclitaxel combined with S-1 and intraperitoneal infusion of nafamostat mesilate for gastric cancer with peritoneal dissemination
Region	Japan

Condition
Condition	Gastric cancer with peritoneal dissemination
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safity and toxicity of the treatment with PTX/S-1/FUT175 and to determine the MTD and RD
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	To evaluate the safety and determine RD
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Paclitaxel is administered intravenously at 50 mg/m2 and intraperitoneally at 20 mg/m2 on days 1 and 8. Nafamostat mesilate is administered intraperitoneally with an initial dose of 40 mg/body, stepped up to 60 or 80 mg/body. S-1 is administered at 80 mg/m2/day for 14 consecutive days, followed by 7 days rest. The cycle is repeated every 3 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Histologically proven unresectable or recurrent gastric adenocarcinoma; peritoneal dissemination and/or cancer cells on peritoneal cytology; age more than 20 years; Eastern Cooperative Oncology Group performance status 0-1; adequate bone marrow function (leukocyte count 3,000-12,000/mm3, hemoglobin >= 8.0 g/dl, platelets >= 100,000/mm3 ); adequate liver function (AST/ALT </= 100, total bilirubin </=2.0 mg/dL); adequate renal function(BUN </= 1.0 x ULN, serum creatinine </= 1.2mg/dL, creatinine clearance>= 60 ml/min), adequate oral intake, and an expected survival period of more than 3 months.
Key exclusion criteria	Metastasis to distant organ sites (such as the liver, lungs or bone), other active concomitant malignancies, or other severe medical conditions (such as pulmonary fibrosis, active infection, uncontrollable heart disease, uncontrollable diabetes mellitus, history of severe drug allergy).
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Middle name Last name Norio Mitsumori
Organization	The Jikei University School of Medicine
Division name	Division of Gastrointestinal surgery, Department of Surgery
Zip code
Address	3-25-8, Nishi-shinbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Email	mitsumori@jikei.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Norio Mitsumori
Organization	The Jikei University School of Medicine
Division name	Division of Gastrointestinal surgery, Department of Surgery
Zip code
Address	3-25-8, Nishi-shinbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Homepage URL
Email	mitsumori@jikei.ac.jp

Sponsor
Institute	The Jikei University School of Medicine
Institute
Department

Funding Source
Organization	Department of Surgery, The Jikei University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 11 Month 01 Day
Date of IRB	2013 Year 11 Month 01 Day
Anticipated trial start date	2013 Year 11 Month 01 Day
Last follow-up date	2019 Year 03 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 08 Month 12 Day
Last modified on	2021 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021585