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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018658
Receipt No. R000021585
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
Date of disclosure of the study information 2015/09/01
Last modified on 2015/08/12

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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 Open public recruiting
Date of protocol fixation
2013 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 01 Day
Last follow-up date
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
2015 Year 08 Month 12 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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