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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001741
Receipt No. R000002098
Scientific Title Phase II study of S-1 combined with irinotecan in patients with advanced colorectal cancer
Date of disclosure of the study information 2009/02/28
Last modified on 2009/02/28

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Basic information
Public title Phase II study of S-1 combined with irinotecan in patients with advanced colorectal cancer
Acronym Phase II study of S-1 combined with irinotecan
Scientific Title Phase II study of S-1 combined with irinotecan in patients with advanced colorectal cancer
Scientific Title:Acronym Phase II study of S-1 combined with irinotecan
Region
Japan

Condition
Condition Advanced colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the efficacy, tolerability, and impact on quality-of-life of the oral fluoropyrimidine S-1 plus irinotecan in patients with advanced colorectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the efficacy, tolerability, and impact on quality-of-life
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 S-1 combined with irinotecan
Interventions/Control_2
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) histological confirmation of colorectal cancer; (2) inoperable metastatic disease or recurrent disease after surgery; (3) measurable lesions; (4) age 20-79 years old; (5) Eastern Cooperative Oncology Group (ECOG) scale performance status (PS) 0,1 ; (6) adequate bone marrow function (7) adequate liver function ; (8) adequate renal function ; (9) provision of written informed consent.
Key exclusion criteria 1)prior chemotherapy received for advanced disease; 2)other severe medical conditions; 3)other active malignancies;
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Tsunoda
Organization Showa University School of Medicin
Division name Department of Gastroenterological and General Surgery
Zip code
Address 1-5-8, Hatanodai, Shinagawa, 142-8666, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Showa University School of Medicin
Division name Department of Gastroenterological and General Surgery
Zip code
Address
TEL
Homepage URL
Email at1151proc@med.showa-u.ac.jp

Sponsor
Institute Showa University School of Medicin
Institute
Department

Funding Source
Organization Showa University School of Medicin,Department of Gastroenterological and General Surgery
Organization
Division
Category of Funding Organization Other
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
2009 Year 02 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
2004 Year 02 Month 26 Day
Date of IRB
Anticipated trial start date
2004 Year 06 Month 01 Day
Last follow-up date
2009 Year 01 Month 01 Day
Date of closure to data entry
2009 Year 01 Month 01 Day
Date trial data considered complete
2009 Year 01 Month 01 Day
Date analysis concluded
2009 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 02 Month 28 Day
Last modified on
2009 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002098

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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