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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000360
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of gastroenterology,
Tokyo University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000446

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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