UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003703 |
|---|---|
| Receipt number | R000004485 |
| Scientific Title | Phase I trial of Cetuximab combined with S-1 and irrinotecan in advanced colorectal cancer |
| Date of disclosure of the study information | 2010/06/07 |
| Last modified on | 2014/06/04 18:56:23 |
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Basic information
Public title
Phase I trial of Cetuximab combined with S-1 and irrinotecan in advanced colorectal cancer
Acronym
Phase I trial of Cetuximab combined with S-1 and irrinotecan in advanced colorectal cancer
Scientific Title
Phase I trial of Cetuximab combined with S-1 and irrinotecan in advanced colorectal cancer
Scientific Title:Acronym
Phase I trial of Cetuximab combined with S-1 and irrinotecan in advanced colorectal cancer
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to establish the feasibility and efficacy of Cetuximab combined with S-1 and irrinotecan in advanced colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum tolerated dose
Recommended dose
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
Cetuximab: Weekly administration 400 mg/m2 for the 1st time (day1), 250mg/m2/week for the 2nd time or another (day8,15,..)
TS-1 is orally administered b.i.d. on days 1-14 and CPT-11 is intravenously administered on days 1 every 3 weeks
S-1:Level1 65mg/m2 day1-14
Level2 80mg/m2 day1-14
CPT-11:Level1,2 150mg/m2, day1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Histologically confirmed colorectal cancer
2.KRAS wild type
3.Patients with no prior chemotherapy
4. Age >=20
5. ECOG performance status 0 or 1
6.Life expectancy of more than 3 months
7. Sufficient organ functions
WBC 3,000/mm3-12,000/mm3
Neurtophils >=1,500/mm3
Platelets >=100,000/mm3
Hemoglobin >=9.0g/dl
Total bilirubin <=1.5mg/dl
GOT and GPT <=100IU/l
Creatinine <1.2mg/dl
Creatinine Crearance >=60ml/min
8.the case can eat
9Written IC
Key exclusion criteria
1. Multiple malignancies
2. Serious complications(intestinal paralysis and intestinal obstruction, interstitial pneumonia, pulmonary fibrosis,renal failure, cardiac failure , liver failure)
3.Infection
4.Diarrhea
5. mechanical bowel obstruction
6.Uncontrolable pleural effusion or ascites requiring
7.History of serious drug hypersensitivity
8.Need to treatment with flucytosine, atazanavir sulfate
9.Fresh bleeding of digestive organs
10.Cirrhosis, Icterus
11.Evidence of psychiatric disability interfering with enrollment to clinical trial
12.Need to treatment with heart failure, ischemic heart disease or arrhythmia
13.Uncontrolable diabetes
14.Symptomatic brain metastasis
15.Pregnant or lactating women or women of childbearing potential.
16.Patients judged inappropriate for this study by physicians
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Koike |
Organization
Toho University school of Medicine
Division name
Division of general and gastroenterological surgery, Department of Surgery (Omori)
Zip code
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541. Japan
TEL
03-3762-4151
jkoike18@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Koike |
Organization
Toho University school of Medicine
Division name
Division of general and gastroenterological surgery, Department of Surgery (Omori)
Zip code
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541. Japan
TEL
03-3762-4151
Homepage URL
jkoike18@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University school of Medicine
Institute
Department
Personal name
Funding Source
Organization
Toho University school of Medicine
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
| 2010 | Year | 06 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 03 | Day |
Last modified on
| 2014 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004485
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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