臨床研究等提出・公開システム

Date of registration	Nov. 10, 2009
Last modified on	Dec. 17, 2018
Trial ID	jRCT1080220913

Scientific Title	A prospective observational study of the efficacy and safety of CPT-11 based regimens for UGT1A1 genotype guided patients with metastatic colorectal cancer
Public Title	A prospective observational study of the efficacy and safety of CPT-11 based regimens for UGT1A1 genotype guided patients with metastatic colorectal cancer

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	DAIICHI SANKYO COMPANY, LIMITED
	Address	+81-3-6225-1047
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHI SANKYO COMPANY, LIMITED
	Address	+81-3-6225-1047
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		2000
Study Type		Observational
Study Design	Study Design	Prospective, cohort
Study Design	Objective
Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	1. Metastatic colorectal cancer (adenocarcinoma) 2. Patients to receiving FOLFIRI, CPT-11+S-1 and CPT-11 alone therapy (with or without molecular targeted agents) Age requirement none
	Exclusion Criteria	1. Contraindications of CPT-11 2. ECOG PS 3-4 3. Patients to receiving CPT-11 as adjuvant chemotherapy 4. History of a pelvic irradiation
	Minimum Age	No limit
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Metastatic colorectal cancer (adenocarcinoma)
Intervention(s)		investigational material(s) Generic name etc : Irinotecan hydrochloride INN of investigational material : Therapeutic category code : 424 Antineoplastic preparations extracted from plants Dosage and Administration for Investigational material : Approved doses and schedules control material(s) Generic name etc : None INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : None
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Progression free survival None
Secondary Outcome		Overall survival, Time to treatment failure, response rate, disease control rate and safety None

Primary Sponsor	DAIICHI SANKYO COMPANY, LIMITED
Secondary Sponsor	None

Name of Funding Organization	None
Name of Research Funding

Name of Funding Organization
Name of Research Funding	None

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

Secondary ID No.	JapicCTI-090945
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	July. 13, 2016	Detail	Changes
7	July. 13, 2016	Detail	Changes
6	April. 10, 2013	Detail	Changes
5	April. 10, 2013	Detail	Changes
4	Mar. 29, 2011	Detail	Changes
3	Mar. 29, 2011	Detail	Changes
2	Nov. 10, 2009	Detail	Changes
1	Nov. 10, 2009	Detail

List of change history