UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of S-1 and CDDP chemotherapy with short hydration for advanced Gastric Cancer
Title of the study (Brief title)	Feasibility study of S-1 and CDDP chemotherapy with short hydration for advanced Gastric Cancer
Region	Japan

Condition
Condition	advanced and/or recurrent gastric cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate feasibility of S-1+CDDP chemotherapy with short hydration
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Safety
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	S-1 is orally administered for 21 days followed by 14 days rest according to body surface area. CDDP is administered intravenously in each dosage of level at day 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Histologically proven adenocarcinoma of advanced gastric cancer(included esophagogastric junction) 2)CDDP-na&iuml;ve patients 3)ECOG Performance status(PS) of 0-1. 4)Age of 20 years or older. 5 ) Life expectancy is less than 3 months 6)no severe organ failure 7) possible to oral intake 8) written informed consent
Key exclusion criteria	(1) Patient with administration contraindication of S-1 or CDDP (2,3,4,5) pts with active co-morbidities including severe conditions of heart diseases, gastric ulcers, infections, ileus, uncontrollable diabetes, hypertension, renal failure, hepatic cirrhosis, active interstitial. (6) Symptomatic pleural effusion or ascites (7) metastasis to the brain (8) Watery diarrhea (9) Symptomatic psychological disease (10)Concomitant therapy with flucytocine or phenytoin (11)Pregnancy or breast feeding (12)Decision as ineligible by principal investigator
Target sample size	50

Research contact person
Name of lead principal investigator	Yoshio Naomoto
Organization	Kawasaki Medical School
Division name	Department of General Surgery
Address	2-6-1, Nakasange, Kita-Ward, Okayama-City, Okayama-Prefecture
TEL	086-225-2111
Email	ynaomoto@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Tomoki Yamatsuji
Organization	Kawasaki Medical School
Division name	Department of General Surgery
Address	2-6-1 Nakasange, Kita-ku, Okayama City, Okayama, 700-8505, Japan
TEL	086-225-2111
Homepage URL
Email	yama-t@med.kawasaki-m.ac.jp

Sponsor
Institute	NPO Japan Southwest Oncology Research Support Organization (JSWOG)
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2012 Year 03 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 06 Month 29 Day
Anticipated trial start date	2012 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 02 Month 29 Day
Last modified on	2017 Year 03 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006943