臨床研究等提出・公開システム

Date of registration	Jan. 25, 2006
Last modified on	Dec. 17, 2018
Trial ID	jRCT1080220199

Scientific Title	Phase II/III Trial of CPT-11/5-FU/l-LV (FOLFIRI) Versus CPT-11/TS-1 (IRIS) as Second Line Chemotherapy of Unresectable Colorectal 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	Taiho Pharmaceutical Co., Ltd.
	Address	toiawase@taiho.co.jp
	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	Open label, multicenter phase 2 / 3 study
Study Design	Objective
Phase		2-3
Key inclusion & exclusion criteria	Inclusion Criteria	Histologically confirmed colorectal cancer Locally advanced and/or metastatic colorectal cancer Have prior chemotherapy as first line treatment Age 20 to 75 Performance status 0 or 1 (ECOG)
	Exclusion Criteria
	Minimum Age	20age old over
	Maximum Age	75age old under
	Gender	Both
Health Condition or Problem Studied		Unresectable Colorectal Cancer
Intervention(s)		investigational material(s) Generic name etc : Irinotecan hydrochloride \| Tegafur/Gimeracil/ Oteracil Potassium \| Fluorouracil \| Levofolinate Calcium INN of investigational material : Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Investigational material : Irinotecan hydrochloride : injection, Fluorouracil : injection, Levofolinate Calcium : injection, Tegafur/Gimeracil/ Oteracil Potassium capsule : oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Progression free survival
Secondary Outcome

Primary Sponsor	Taiho Pharmaceutical 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-060202
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
12	Dec. 17, 2018	(this page)	Changes
11	Jan. 05, 2015	Detail	Changes
10	Jan. 05, 2015	Detail	Changes
9	April. 10, 2013	Detail	Changes
8	April. 10, 2013	Detail	Changes
7	Jan. 10, 2012	Detail	Changes
6	April. 01, 2007	Detail	Changes
5	April. 01, 2007	Detail	Changes
4	Dec. 18, 2006	Detail	Changes
3	Dec. 18, 2006	Detail	Changes
2	Jan. 30, 2006	Detail	Changes
1	Jan. 25, 2006	Detail

List of change history