UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017396 |
|---|---|
| Receipt number | R000020180 |
| Scientific Title | Multicenter Center of Prospective Study of Combination Chemotherapy with Cetuximab In metastatic Colorectal Cancer |
| Date of disclosure of the study information | 2015/05/02 |
| Last modified on | 2015/12/04 17:05:07 |
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Basic information
Public title
Multicenter Center of Prospective Study of Combination Chemotherapy with Cetuximab In metastatic Colorectal Cancer
Acronym
Multicenter Center of Prospective Study of Combination Chemotherapy with Cetuximab In metastatic Colorectal Cancer
Scientific Title
Multicenter Center of Prospective Study of Combination Chemotherapy with Cetuximab In metastatic Colorectal Cancer
Scientific Title:Acronym
Multicenter Center of Prospective Study of Combination Chemotherapy with Cetuximab In metastatic Colorectal Cancer
Region
| Japan |
Condition
Condition
Unresectable colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim is to evaluate the efficacy and safety of cetuximab as the first line chemotherapy for unresectable colorectal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase I
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Resection rate, Progression free survival, Overall survival, Safety
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. The cases histologically diagnosed as colorectal cancer
2. The cases without a history of chemotherapy
3. The cases with evaluative cancer lesions based on RECIST
4. The cases with wild-type about KRAS status
5. The age is 20 years old and older.
6. Performance status is 0-2 cases
7. A major organ function is maintained by a laboratory study.
8. The cases could survive at least for 3 months from the registration day.
9. An agreement is obtained in a document from the patients.
Key exclusion criteria
1. The cases with serious drug hypersensitivity or allergy
2. Multiple primary cancers
3. The cases with symptomatic brain metastasis
4. The cases with infectious disease requiring systemic therapy
5. The cases with serious complications
- Interstitial pneumonia, pulmonary fibrosis
- Heart failure
- Renal failure
- Liver failure
- Poor control diabetes mellitus
- Icterus
6. Pregnant or lactating women
7. The cases judged to be unsuitable for registration
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akinobu Taketomi |
Organization
Hokkaido University Graduate school of medicine
Division name
Gastroenterological Surgery1
Zip code
Address
North15 West7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5927
taketomi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihiko Takahashi |
Organization
Hokkaido University Hospital
Division name
Gastroenterology1
Zip code
Address
North15 West7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5927
Homepage URL
noripiko@med.hokudai.ac.jp
Sponsor or person
Institute
Gastroenterological Surgery1, Hokkaido University Graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
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
| 2015 | Year | 05 | Month | 02 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 08 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | 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
observation of response rate
Management information
Registered date
| 2015 | Year | 05 | Month | 02 | Day |
Last modified on
| 2015 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020180
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
