UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000961 |
|---|---|
| Receipt number | R000001156 |
| Scientific Title | Feasibility study of neoadjuvant chemotheray mFOLFOX6 for resectable liver metastases of colorectal cancers |
| Date of disclosure of the study information | 2008/01/07 |
| Last modified on | 2012/01/06 12:07:30 |
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Basic information
Public title
Feasibility study of neoadjuvant chemotheray mFOLFOX6 for resectable liver metastases of colorectal cancers
Acronym
Feasibility study of neoadjuvant chemotheray mFOLFOX6 for resectable liver metastases of colorectal cancers
Scientific Title
Feasibility study of neoadjuvant chemotheray mFOLFOX6 for resectable liver metastases of colorectal cancers
Scientific Title:Acronym
Feasibility study of neoadjuvant chemotheray mFOLFOX6 for resectable liver metastases of colorectal cancers
Region
| Japan |
Condition
Condition
colorectal cancers
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of liver resection for metastatic lesions from colorectal cancers after neoadjuvant chemotherapy (mFOLFOX6)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Curative resection rates of liver metastases
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
| Maneuver |
Interventions/Control_1
Surgery
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) Histologically diagnosed as colorectal adenocarcinomas, including cecal, appendecal, and anal canal cancers.
2) Liver lesions are measurable by spiral CT or SPIO-MRI scans.
3) Extrahepatic lesions include lung metastases which can be resected curatively.
4) Curative resection for metastatic lesions can be performed with residual hepatic functions preserved.
5) No prior treatment histories for liver lesions, including L-OHP regimens, hepatectomy, hepatic arterial infusion, MCT, or RFA
6) No evidence of chronic hepatic diseases which affect systemic chemotherapy and/or surgical resection
7) Performance status (ECOG): 0-1
8) Vital organ functions, including hematopoietic, cardiac, respiratory and renal functions, are preserved.
Key exclusion criteria
Excluded are cases with conditions as below:
1) Peritoneal or pleural fluid retention to be drainaged.
2) Multiple malignancies to be treated.
3) Peripheral neural disturbances.
4) Active infectious diseases.
5) Severe watery diarrhea.
6) Mental disturbances.
7) Treatment history of continuous, oral or intravenous steroid therapy.
8) Previous history of ischemic heart diseases.
9) Coexistent severe diseases including pulmonary fibrosis, interstitial pneumonia, ileus, uncontrollable diabetes, cardiac dysfunction, hepatic failure, or renal failure.
10) Pregnant.
11) Previous history of severe drug-induced allergy.
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Nagayama |
Organization
Kyoto Univ Hospital
Division name
Surgery
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto City
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto Univ Hospital
Division name
Surgery
Zip code
Address
TEL
075-751-3227
Homepage URL
Sponsor or person
Institute
Dept. Surgey
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Dept. Surgey
Kyoto University Hospital
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
| 2008 | Year | 01 | 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
Date of protocol fixation
| 2007 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 12 | Month | 30 | Day |
Last modified on
| 2012 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001156
| 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 |
