UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trial of S-1 plus intravenous and intraperitoneal paclitaxel for gastric cancer with peritoneal metastasis or positive peritoneal cytology
Acronym	Clinical trial of S-1 plus intravenous and intraperitoneal paclitaxel for gastric cancer with peritoneal metastasis or positive peritoneal cytology
Scientific Title	Clinical trial of S-1 plus intravenous and intraperitoneal paclitaxel for gastric cancer with peritoneal metastasis or positive peritoneal cytology
Scientific Title:Acronym	Clinical trial of S-1 plus intravenous and intraperitoneal paclitaxel for gastric cancer with peritoneal metastasis or positive peritoneal cytology
Region	Japan

Condition
Condition	Gastric cancer with peritoneal metastasis or positive peritoneal cytology.
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of S-1 plus intravenous and intraperitoneal paclitaxel for gastric cancer with peritoneal metastasis or positive peritoneal cytology
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety
Key secondary outcomes	Disease control rate. three year overall survival. Progression free survival.

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	S-1 was administered orally at a dose 80mg/m2/day for 14 consecutive days, followed by 7days of rest. PTX was administered intravenou at a dose of 50mg/m2 and intraperitoneal at a dose of 20mg/m2 on days 1 and 8.
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	1) histologically proven primar gastric adenocarcinoma. 2) Peritneal metastasis and/or cancer cells on peritoneal cytology. 3) Adequate function of important organs (witin 14 days before registration). Neutrocyte >= 1,000/mm3 Hemoglobin >= 8.0g/dl Platelet >= 75,000/mm3 serum transaminases < 100U/L Total Bilirubin <= 3.0mg/dL Creatinine clearance >= 30ml/min 4) Eastern Cooperative Oncology Group performance status 0-2 5) Age >= 20, < 85 years 6) Written informed consent.
Key exclusion criteria	1)The absence of metastasis to distant organ sites except the retroperitoneum, ovary and abdominal lymph nodes. 2)Contraindication to S-1 or paclitaxel. 3)Apparent infection or inflammation. 4)Sever heart disease. 5)Sever complication. 6)Gastrointestinal bleeding requiring blood transfusion repeatedly. 7)Pregnancy, breast feeding or intention to become pregnant. 8)Judeged inappropriate for this trial for other reasons.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hirohiko Kuroda
Organization	Tottori University School of Medicine
Division name	Division of Surgical Oncology
Zip code
Address	36-1 Nishi-cho, Yonago, Tottori
TEL	0859-38-6567
Email	kuroda-ttr@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hirohiko Kuroda
Organization	Tottori University School of Medicine
Division name	Division of Surgical Oncology
Zip code
Address	36-1 Nishi-cho, Yonago, Tottori
TEL	0859-38-6567
Homepage URL
Email	kuroda-ttr@umin.ac.jp

Sponsor
Institute	Tottori University Hospital
Institute
Department

Funding Source
Organization	Tottori University Hospital
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	2017 Year 05 Month 19 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	2017 Year 05 Month 01 Day
Date of IRB	2017 Year 05 Month 01 Day
Anticipated trial start date	2017 Year 05 Month 19 Day
Last follow-up date	2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 05 Month 18 Day
Last modified on	2019 Year 06 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031281