UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004580 |
|---|---|
| Receipt number | R000005471 |
| Scientific Title | Study of Cetuximab + Irinotecan + S-1 as first line therapy in metastatic colorectal cancer with KRAS wild type |
| Date of disclosure of the study information | 2010/11/18 |
| Last modified on | 2018/11/25 00:32:57 |
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Basic information
Public title
Study of Cetuximab + Irinotecan + S-1 as first line therapy in metastatic colorectal cancer with KRAS wild type
Acronym
CIRIS study
Scientific Title
Study of Cetuximab + Irinotecan + S-1 as first line therapy in metastatic colorectal cancer with KRAS wild type
Scientific Title:Acronym
CIRIS study
Region
| Japan |
Condition
Condition
Metastatic colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Cetuximab + Irinotecan + S-1 as first line in metastatic colorectal cancer with KRAS wild type
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response Rate
Key secondary outcomes
Overall Survival
Progression Free Survival
Safety
Best response: % change at baseline
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
IRIS + Cetuximab
Cetuximab loading dose 400mg/m2, 250 mg/m2/week
Irinotecan 100 mg/m2/biweekly S-1 80,100,120 mg/twice/day 1-14, following two weeks off
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. Patients with histologically proven colorectal cancer
2. Metastatic colorectal cancer
3. KRAS wild type
4. No prior chemotherapy for metastatic colorectal cancer
5. Age over 20
6. ECOG Performance Status 0-1
7. A measurable lesion is confirmed with objective documents such as CT, MRI and the X-ray check within 30th before registration.
8. Patients have enough organ function for study treatment.
9. Enable to internal use
10. Life expectancy of more than 3 months
11. Written informed consent
Key exclusion criteria
1. Sever myeloablation
2. Severe infectious disease
3. Sensory alteration or paresthesia interfering with function
4. A mental disorder, nucleus neuropathy, cerebrovascular neuropathy failure
5. Comorbidity or history of heart failure
6. Interstitial lung disease or pulmonary fibrosis
7. Prior radiotherapy for primary and metastases tumors
8. History of severe allergy
9. Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test
10. Sever comorbidity (renal failure, liver failure, hypertension, high calcium, etc)
11. Symptomatic brain metastases
12. Patient have metachronous multiple malignancy
13. Any other cases who are regarded as inadequate for study enrollmet by investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori Sakai |
Organization
Tsuchiura kyodo general hospital
Division name
Department of Gastroenterology
Zip code
Address
11-7 Manabeshinmachi, Tsuchiura, Ibaraki, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiki Masuishi |
Organization
Tsuchiura kyodo general hospital
Division name
Department of Gastroenterology
Zip code
Address
11-7 Manabeshinmachi, Tsuchiura, Ibaraki, Japan
TEL
Homepage URL
Sponsor or person
Institute
Tsuchiura kyodo general hospital
Institute
Department
Personal name
Funding Source
Organization
none
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 | 11 | Month | 18 | 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
| 2010 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 18 | Day |
Last modified on
| 2018 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005471
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
