UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000013 |
|---|---|
| Receipt number | R000000025 |
| Scientific Title | A randomized controlled trial by a parallel group design in multi-institutions to evaluate the effectiveness of oral adjuvant chemotherapy using Leucovorin and Tegaful/Uracil to prevent recurrence after resection of liver metastasis from colorectal carcinoma. |
| Date of disclosure of the study information | 2005/07/01 |
| Last modified on | 2017/03/26 16:48:25 |
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Basic information
Public title
A randomized controlled trial by a parallel group design in multi-institutions to evaluate the effectiveness of oral adjuvant chemotherapy using Leucovorin and Tegaful/Uracil to prevent recurrence after resection of liver metastasis from colorectal carcinoma.
Acronym
A randomized controlled trial for adjuvant LV+UFT therapy after resection of liver metastasis from colorectal carcinoma.
Scientific Title
A randomized controlled trial by a parallel group design in multi-institutions to evaluate the effectiveness of oral adjuvant chemotherapy using Leucovorin and Tegaful/Uracil to prevent recurrence after resection of liver metastasis from colorectal carcinoma.
Scientific Title:Acronym
A randomized controlled trial for adjuvant LV+UFT therapy after resection of liver metastasis from colorectal carcinoma.
Region
| Japan |
Condition
Condition
Cases with liver metastasis from colorectal carcinoma, which is removed curatively and surgically.
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of oral administration of Leucovorin and Tegaful/Uracil as adjuvant chemotherapy to prevent recurrence after resection of liver metastasis from colorectal carcinoma, by comparing the disease-free survivals between surgery alon and surgery with adjuvant therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Disease-free survival
Key secondary outcomes
Overall survival
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
Oral administration of Leucovorin (75mg/day) and Tegaful/Uracil (300mg/body surface area m2/day) for 5 courses (5 weeks of administration followed by 1 week of no administration) after curative resection of liver metastasis from colorectal carcinoma.
Interventions/Control_2
Only follow-up without any anti-cancer therapy after curative resection 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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing first or second resection for liver metastasis from colorectal carcinoma. No residual disease after surgery and no disease except for liver metastasis and the primary colorectal carcinoma.
Key exclusion criteria
The patients with other malignant disease, post-operative severe complications, and surgical margin positivity.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Kokudo |
Organization
Tokyo University Hospital
Division name
Hepato-Biliary-Pancreatic Surgery Division
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411(33320)
KOKUDO-2SU@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihiro Kokudo |
Organization
Tokyo University Hospital
Division name
Hepato-Biliary-Pancreatic Surgery Division
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411(33320)
Homepage URL
https://center.umin.ac.jp/islet/lvuft/
KOKUDO-2SU@h.u-tokyo.ac.jp
Sponsor or person
Institute
Hepato-Biliary-Pancreatic Surgery Division, Tokyo University Hospital
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Science, Sports and Culture.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japanese Foundation for Multidisciplinary Treatment of Cancer.
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
| 2005 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2003 | Year | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 05 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2005 | Year | 06 | Month | 17 | Day |
Last modified on
| 2017 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000025
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/03/26 | ProtocolHasegawaK.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
