臨床研究等提出・公開システム

Date of registration	Sept. 09, 2005
Last modified on	Dec. 17, 2018
Trial ID	jRCT1080220081

Scientific Title	A randomized phase III trial of S-1 versus S-1 plus irinotecan in advanced gastric cancer.
Public Title

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Yakult Honsha Co., Ltd.
	Address	+81-3-5550-8962
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHI SANKYO Co., Ltd.
	Address	http://www.daiichisankyo.co.jp/contact/index.html
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Randomized, open-label, multicenter phase III study
Study Design	Objective
Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	Histologically confirmed unresectable or relapsed gastric cancer Neither prior chemotherapy nor prior radiotherapy Age between 20 and 75 years old ECOG Performance Status: 0-2
	Exclusion Criteria
	Minimum Age	20age old over
	Maximum Age	75age old under
	Gender	Both
Health Condition or Problem Studied		Advanced gastric cancer
Intervention(s)		investigational material(s) Generic name etc : Irinotecan and S-1 INN of investigational material : Therapeutic category code : 424 Antineoplastic preparations extracted from plants Dosage and Administration for Investigational material : Irinotecan: injection, S-1: oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Overall survival
Secondary Outcome

Primary Sponsor	Yakult Honsha Co., Ltd. ,DAIICHI SANKYO Co.,Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name	None
Address
Phone Number
E-mail Address
Status of Review
Date of Approval

Secondary ID No.	JapicCTI-050083
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
12	Dec. 17, 2018	(this page)	Changes
11	Aug. 01, 2011	Detail	Changes
10	Aug. 01, 2011	Detail	Changes
9	Oct. 05, 2009	Detail	Changes
8	Oct. 05, 2009	Detail	Changes
7	April. 01, 2007	Detail	Changes
6	April. 01, 2007	Detail	Changes
5	Dec. 14, 2006	Detail	Changes
4	Dec. 14, 2006	Detail	Changes
3	Dec. 21, 2005	Detail	Changes
2	Dec. 02, 2005	Detail	Changes
1	Sept. 09, 2005	Detail

List of change history