UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN C000000013
Receipt No. 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

* 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 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)
Email 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/
Email KOKUDO-2SU@h.u-tokyo.ac.jp

Sponsor
Institute Hepato-Biliary-Pancreatic Surgery Division, Tokyo University Hospital
Institute
Department

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
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
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
URL(English) https://upload.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


Contact us.