UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001365 |
|---|---|
| Receipt number | R000001661 |
| Scientific Title | Phase I/II study of triweekly administration regimen of irinotecan and TS-1 in patients with advanced colorectal cancer |
| Date of disclosure of the study information | 2008/09/10 |
| Last modified on | 2011/02/09 19:59:02 |
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Basic information
Public title
Phase I/II study of triweekly administration regimen of irinotecan and TS-1 in patients with advanced colorectal cancer
Acronym
Phase I/II study of irinotecan and TS-1 in patients with advanced colorectal cancer
Scientific Title
Phase I/II study of triweekly administration regimen of irinotecan and TS-1 in patients with advanced colorectal cancer
Scientific Title:Acronym
Phase I/II study of irinotecan and TS-1 in patients with advanced colorectal cancer
Region
| Japan |
Condition
Condition
advanced colorectal cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of TS-1 and irinotecan in patients with advanced colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
1) Phase I
To determine the recommended dose
2) Phase II
Response Rate
Key secondary outcomes
Safety, Overall survival, Progression free survival
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
Treatment : TS-1+CPT-11
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) Histological confirmation of colorectal cancer
(2) Advanced colorectal cancer
(3) Measurable disease
(4) No prior chemotherapy/radiotherapy
(5) ECOG-PS:0-2
(6) Adequate major organ function
(7) All patients provided written informed consent
Key exclusion criteria
(1) Massive pleural effusion or massive ascites
(2) Symptomatic brain metastases
(3) Active diarrhea
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eishi Baba |
Organization
Kyushu University Hospital
Division name
Division of Hematology and Oncology
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka812-8582, Japan
TEL
092-642-5232
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Kusaba |
Organization
Kyushu University Hospital
Division name
Division of Hematology and Oncology
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka812-8582, Japan
TEL
092-642-5232
Homepage URL
Sponsor or person
Institute
Kyushu Medical Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Kyushu Medical Oncology 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
| 2008 | Year | 09 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2004 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2010 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 09 | Month | 10 | Day |
Last modified on
| 2011 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001661
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| Registered date | File name |
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