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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001617
Receipt No. R000001945
Scientific Title A multicenter phase I/II study of irinotecan (CPT-11) and S-1 combination chemotherapy for metastatic colorectal cancer (CRC)
Date of disclosure of the study information 2009/01/06
Last modified on 2009/10/28

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Basic information
Public title A multicenter phase I/II study of irinotecan (CPT-11) and S-1 combination chemotherapy for metastatic colorectal cancer (CRC)
Acronym C-0401
Scientific Title A multicenter phase I/II study of irinotecan (CPT-11) and S-1 combination chemotherapy for metastatic colorectal cancer (CRC)
Scientific Title:Acronym C-0401
Region
Japan

Condition
Condition advanced/recurrent colorectal cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of CPT-11 and S-1 combination chemotherapy for metastatic colorectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I : recommended dose
Phase I I: Response rate
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 Irinotecan+S-1, repeated every 3 weeks.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1.colorectal cancer, cytologically and/or histrogically,
2.Unresectable advanced/recurrent colorectal cancer
3. age: 20-75 years old
4. Performance Status (ECOG): 0,1
5. with measurable lesions
6.No prior chemotherapy / radiotherapy
7. the last prior therapy before more than 12 weeks of registration
8. Sufficient organ functions
9.witten informed consents
Key exclusion criteria 1. Serious drug hypersensitivity or a history of drug allergy
2. Plerral effusion, peritoneal fluid and pericardial fluid
3.Active infections
4. Water solubility diarrhea, in case of the patient who has a colostomy, diarrhea impairs daily life activity
5.Intestines tube paralysis, intestinal obstruction and peptic ulcer
6. interstitial pnumonitis, pulmonary fibrosis
7.Need to treatment with flucytosine
8.Active concomitant malignancy
9.diabetic that cannot be controlled
10. symptomatic or asymptomatic but treated heart disease
11. histry of mental disturbances or cerebrovascular attach
12. under coutinuous steroid therapy
13. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers
14.Other conditions not suitable for this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Maehara Yoshihiko
Organization Kyushu University
Division name Dpt. of surgery and science
Zip code
Address Maidashi 3-1-1, Higashi-ku, Fukuoka, 812-8582
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyushu University
Division name Dpt. of surgery and science
Zip code
Address Maidashi 3-1-1, Higashi-ku, Fukuoka, 812-8582
TEL
Homepage URL
Email

Sponsor
Institute CPT-11/TS-1 study group
Institute
Department

Funding Source
Organization CPT-11/TS-1 study group
Organization
Division
Category of Funding Organization Self funding
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 01 Month 06 Day

Related information
URL releasing protocol
Publication of results Partially published

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 No longer recruiting
Date of protocol fixation
2004 Year 01 Month 16 Day
Date of IRB
Anticipated trial start date
2004 Year 02 Month 01 Day
Last follow-up date
2007 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 01 Month 06 Day
Last modified on
2009 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001945

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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