UMIN-CTR Clinical Trial

Basic information
Public title	Phase I study of S-1 plus cisplatin and intraperitoneal administration of paclitaxel for gastric cacner with peritoneal metastasis
Acronym	Phase I study of S-1 plus cisplatin and intraperitoneal administration of paclitaxel for gastric cacner with peritoneal metastasis
Scientific Title	Phase I study of S-1 plus cisplatin and intraperitoneal administration of paclitaxel for gastric cacner with peritoneal metastasis
Scientific Title:Acronym	Phase I study of S-1 plus cisplatin and intraperitoneal administration of paclitaxel for gastric cacner with peritoneal metastasis
Region	Japan

Condition
Condition	gastric cancer with peritoneal metastasis
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and determine the recommended dose of intraperitoneal paclitaxel combined with S-1 plus cisplatin
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	safety
Key secondary outcomes	negative conversion rate on peritoneal cytology

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 intraperitoneally on days 1, 8 and 22. S-1 is administered for 21 consecutive days, followed by 14 days rest. Cisplatin is administered on day8.
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	Histologically proven unresectable gastric adenocarcinoma; peritoneal metastasis; age between 20 and 75 years; Eastern Cooperative Oncology Group performance status 0-2; adequate bone marrow function (leukocyte count the lower limit of normal-12,000/mm3, hemoglobin >8.0 g/dl, platelet count >100,000/mm3); adequate liver function (total serum bilirubin < 1.5 * the upper limit of normal, serum transaminases <100/UI); adequate renal function (serum creatinine within the upper limit of normal); and an expected survival period of more than 3 months.
Key exclusion criteria	Other active concomitant malignancies, massive ascites or other severe medical conditions.
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuhiro Kodera
Organization	Nagoya University, Graduate School of Medicine
Division name	Department of Gastroenterology
Zip code
Address	65 Tsurumai-cho Showa-ku Nagoya city
TEL	052-744-2233
Email	ykodera@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Daisuke Kobayashi
Organization	Nagoya University, Graduate School of Medicine
Division name	Department of Gastroenterology
Zip code
Address	65 Tsurumai-cho Showa-ku Nagoya city
TEL	052-744-2249
Homepage URL
Email	kobadai@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	Nagoya University
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	2014 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	9
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	Main results already published
Date of protocol fixation	2014 Year 03 Month 27 Day
Date of IRB	2019 Year 07 Month 08 Day
Anticipated trial start date	2014 Year 04 Month 10 Day
Last follow-up date	2019 Year 06 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 03 Month 27 Day
Last modified on	2020 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015810