臨床研究等提出・公開システム

Date of registration	Sept. 07, 2005
Last modified on	Dec. 17, 2018
Trial ID	jRCT1080220049

Scientific Title	An Open-label, Multicenter, Randomized, 3 Arm Study of S-1 Compared With S-1/CDDP, or S-1/CDDP Compared With 5-FU/CDDP in Patients With Advanced Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease.
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	Taiho Pharmaceutical Co.,Ltd.
	Address	toiawaseCD2@taiho.co.jp
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Taiho Pharmaceutical Co.,Ltd.
	Address	toiawase@taiho.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Open-label, randomized, parallel-group, comparative study.
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	1)Non-prior chemotherapy treated advanced gastric cancer. 2)Non-resectable, locally-advanced or metastatic gastric cancer which is histologically confirmed adenocarcinoma.
	Exclusion Criteria
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Advanced gastric cancer
Intervention(s)		investigational material(s) Generic name etc : S-1 (tegafur + gimeracil + oteracil potassium), CDDP INN of investigational material : S-1:tegafur, gimeracil, oteracil potassium, CDDP:cisplatin Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 21 with a single dose of CDDP 60 mg/m2 will be administered as an 1- to 3-hour IV infusion following the morning dose of S-1 on Day 8. The combination therapy will be repeated every 5 weeks. control material(s) Generic name etc : S-1 (tegafur + gimeracil + oteracil potassium) INN of investigational material : S-1:tegafur, gimeracil, oteracil potassium Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 28 repeated 6 weeks. Generic name etc : 5-FU, CDDP INN of investigational material : 5-FU:fluorouracil, CDDP:cisplatin Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : 5-FU 600 mg/m2/24 hours administered intravenously as a CI over 120 hours (Days 1 through 5) along with a 30-minute infusion CDDP 20 mg/m2 from Day 1 through Day 5. The control treatment arm will be repeated every 4 weeks.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Antitumor effect and time to treatment failure
Secondary Outcome

Primary Sponsor	Taiho Pharmaceutical Co., Ltd.
Secondary Sponsor

Name of Funding Organization	Taiho Pharmaceutical Co.,Ltd.
Name of Research Funding

Name	-
Address
Phone Number
E-mail Address
Status of Review
Date of Approval

Secondary ID No.	JapicCTI-050049
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
10	Dec. 17, 2018	(this page)	Changes
9	July. 14, 2011	Detail	Changes
8	July. 14, 2011	Detail	Changes
7	Dec. 27, 2010	Detail	Changes
6	July. 12, 2010	Detail	Changes
5	July. 12, 2010	Detail	Changes
4	June. 19, 2010	Detail	Changes
3	June. 14, 2010	Detail	Changes
2	Oct. 03, 2005	Detail	Changes
1	Sept. 07, 2005	Detail

List of change history