UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001741 |
|---|---|
| Receipt number | 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 11:09:54 |
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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
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
at1151proc@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University School of Medicin
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002098
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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