UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017397 |
|---|---|
| Receipt number | R000020183 |
| Scientific Title | Hepatic Resection for Colorectal Liver Metastases following Panitumumab(Vectibix) with Chemotherapy Cohort study |
| Date of disclosure of the study information | 2015/05/02 |
| Last modified on | 2015/12/04 17:05:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Hepatic Resection for Colorectal Liver Metastases following
Panitumumab(Vectibix) with Chemotherapy Cohort study
Acronym
Hepatic Resection for Colorectal Liver Metastases following
Panitumumab(Vectibix) with Chemotherapy Cohort study
Scientific Title
Hepatic Resection for Colorectal Liver Metastases following
Panitumumab(Vectibix) with Chemotherapy Cohort study
Scientific Title:Acronym
Hepatic Resection for Colorectal Liver Metastases following
Panitumumab(Vectibix) with Chemotherapy Cohort study
Region
| Japan |
Condition
Condition
Unresectable colorectalcancer with hepatic metastases
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim is to evaluate the complete hepatic resection rate of panitumumab as the first line chemotherapy for unresectable colorectal cancer with hepatic metastasis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase I
Assessment
Primary outcomes
Complete hepatic resection rate
Key secondary outcomes
Hepatic resection rate, response rate, complications after hepatic resection, adverse event
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 with evaluative resectable hepatic metastatic lesions ,synchronously or metachronously
3. Unresectable hepatic metastases mean anatomic difficulty and so on.
4. The cases with possibility of hepatic resection after panitumumab chemotherapy
5. The age is 20 years old or older.
6. Performance status is 0-2 cases
7. A major organ function is maintained by a laboratory study within 14 days before registration.
8. An agreement is obtained in a document from the patients after informed consent.
Key exclusion criteria
1. The cases with serious drug hyper reaction against panitumumab, fluorouracil folinic acid, oxaliplatin, irinotecan
2. The cases with serious hypersensitivity having functional disorder or sensory disturbance
3. The cases with bone marrow suppression or its history, systemic infection, interstitial pneumonia, diarrhea, ileus, a lot of ascites or hydrothorax, icterus
4. The cases with interstitial pneumonia or its history
5. The cases with serious complications
- Poor control diabetes mellitus
- Heart failure beyond NYHA3
- Renal failure
- Liver failure
6. The cases with mutative or unjudged type about KRAS status
7. The cases without a history of chemotherapy
8. Pregnant or lactating women
9. The cases judged to be unsuitable for registration
Target sample size
100
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 | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 22 | 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 complete hepatic resection 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=R000020183
