UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000360 |
|---|---|
| Receipt number | R000000446 |
| Scientific Title | A randomized controlled trial to evaluate the effectiveness of adjuvant chemotherapy using FOLFOX to prevent recurrence after curative radiofrequency ablation of liver metastasis from colorectal carcinoma |
| Date of disclosure of the study information | 2006/06/01 |
| Last modified on | 2013/09/17 08:17:02 |
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Basic information
Public title
A randomized controlled trial to evaluate the effectiveness of adjuvant chemotherapy using FOLFOX to prevent recurrence after curative radiofrequency ablation of liver metastasis from colorectal carcinoma
Acronym
A randomized controlled trial for adjuvant FOLFOX therapy after radiofrequency ablation of liver metastasis from colorectal carcinoma.
Scientific Title
A randomized controlled trial to evaluate the effectiveness of adjuvant chemotherapy using FOLFOX to prevent recurrence after curative radiofrequency ablation of liver metastasis from colorectal carcinoma
Scientific Title:Acronym
A randomized controlled trial for adjuvant FOLFOX therapy after radiofrequency ablation of liver metastasis from colorectal carcinoma.
Region
| Japan |
Condition
Condition
Cases with liver metastasis from colorectal carcinoma, which is removed curatively by radiofrequency ablation
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of FOLFOX as adjuvant chemotherapy to prevent recurrence after curative ablation of liver metastasis from colorectal carcinoma, by comparing the disease-free survivals between RFA alone and RFA with adjuvant therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Liver metastasis disease-free survival
Key secondary outcomes
Disease-free survival
Overall survival
Side effect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Parenterally administration of mFOLFOX6 for 12 courses after curative radoiofrequency ablation of liver metastasis from colorectal carcinoma
Interventions/Control_2
Only follow-up without any anti-cancer therapy after curative radiofrequency ablation of liver metastasis from colorectal carcinoma
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
Patients undergoing curative radiofrequency ablation for liver metastasis (max 5cm and 5 nodules) from colorectal carcinoma. No residual disease by CT or MRI image after radiofrequency ablation and no disease except for liver metastasis and the primary colorectal carcinoma is resected.
Key exclusion criteria
The patients with other malignant disease, non-curative radiofrequency ablation
Target sample size
190
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masao Omata |
Organization
Tokyo University Hospital
Division name
Deoartment of gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo University Hospital
Division name
Deoartment of gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
Sponsor or person
Institute
Department of gastroenterology,
Tokyo University Hospital
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Science, Sports and Culture.
Organization
Division
Category of Funding Organization
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
| 2006 | Year | 06 | Month | 01 | 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
| 2006 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
| 2011 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 03 | Month | 15 | Day |
Last modified on
| 2013 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000446
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