UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001617 |
|---|---|
| Receipt number | 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 12:43:25 |
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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
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
Sponsor or person
Institute
CPT-11/TS-1 study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001945
