UMIN-CTR Clinical Trial

Basic information
Public title	A phase II trial of TS-1/CDDP as neoadjuvant chemotherapy against resectable gastric cancer.
Acronym	A phase II trial of TS-1/CDDP as neoadjuvant chemotherapy against resectable gastric cancer.
Scientific Title	A phase II trial of TS-1/CDDP as neoadjuvant chemotherapy against resectable gastric cancer.
Scientific Title:Acronym	A phase II trial of TS-1/CDDP as neoadjuvant chemotherapy against resectable gastric cancer.
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim is to evaluate the clinical pathology effects of TS-1 plus cisplatin as a neoadjuvant chemotherapy against resectable gastric cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The effect of the tumor reduction of providing by the chemotherapy effect judgment standard is used. The doctor in charge judges the effect of the tumor reduction based on RECIST(http://www.recist.com/recist-in-practice/22.html) version 1.1.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	TS-1: Day1-21, p.o. and CDDP: Day8. 1 course takes 35 days. 1 course
Interventions/Control_2	TS-1: Day1-21, p.o. and CDDP: Day8. 1 course takes 35 days. 2 courses
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Primary gastric adenocarcinoma 2.The pathological material of the gastric carcinoma before chemotherapy 3.M (-),H (-),c-StageIII and IV in the staging classification 4.Adjustment of Neoadjuvant chemotherapy with TS-1+CDDP 5.Measurable lesions according to RECIST guidelines 6.No history of pretreatment (radiotherapy, chemotherapy,etc.) except surgery 7.PS(ECOG) is 0-2 8.Adequate organ function WBC>=4000/mm3 Neutrophil count>=2,000/mm3 Platelet count>=100,000/mm3 Hemoglobin>=8.0 g/dL 9.Liver function tests AST (GOT) and ALT (GPT) <=100IU/L Total bilirubin<=2.0 mg/dL 10.Renal function test CCr(e-GFR)>=60ml/min Serum creatinine<=1.50 mg/dL 11.Age 20 to 80 years old 12.With written informed consent
Key exclusion criteria	1.Metachronous or synchronous multiple cancer 2.Pregnant or in lactation. 3.Patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge.
Target sample size	110

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Hideaki Shimada
Organization	Toho University School of Medicine
Division name	Division of general and Gastroenterological Surgery,Department of Surgery(Omori)
Zip code
Address	6-11-1 Omori-Nishi,Ota-ku,Tokyo 143-8541,Japan
TEL	03-3762-4151
Email	hideaki.shimada@med.toho-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Hideaki Shimada
Organization	Toho University School of Medicine
Division name	Division of general and Gastroenterological Surgery,Department of Surgery(Omori)
Zip code
Address	6-11-1 Omori-Nishi,Ota-ku,Tokyo 143-8541,Japan
TEL	03-3762-4151
Homepage URL
Email	hideaki.shimada@med.toho-u.ac.jp

Sponsor
Institute	Toho University
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)

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	2010 Year 10 Month 28 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	Completed
Date of protocol fixation	2010 Year 01 Month 22 Day
Date of IRB
Anticipated trial start date	2010 Year 03 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	2010 Year 10 Month 27 Day
Last modified on	2017 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005324

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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