UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018658 |
|---|---|
| Receipt number | 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 | 2021/02/14 14:03:24 |
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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
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
mitsumori@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021585
