UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021146 |
|---|---|
| Receipt number | R000024395 |
| Scientific Title | Phase I study of optimal dose and pharmacokinetics of a Uracil/Tegafur (UFT) plus oral leucovorin regimen after liver resection for colorectal liver metastasis |
| Date of disclosure of the study information | 2016/02/22 |
| Last modified on | 2017/02/22 18:17:16 |
* 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
Phase I study of optimal dose and pharmacokinetics of a Uracil/Tegafur (UFT) plus oral leucovorin regimen after liver resection for colorectal liver metastasis
Acronym
Phase I study of optimal dose and pharmacokinetics of a Uracil/Tegafur (UFT) plus oral leucovorin regimen after liver resection for colorectal liver metastasis
Scientific Title
Phase I study of optimal dose and pharmacokinetics of a Uracil/Tegafur (UFT) plus oral leucovorin regimen after liver resection for colorectal liver metastasis
Scientific Title:Acronym
Phase I study of optimal dose and pharmacokinetics of a Uracil/Tegafur (UFT) plus oral leucovorin regimen after liver resection for colorectal liver metastasis
Region
| Japan |
Condition
Condition
Liver resection for liver metastasis of colorectal cancer
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is designed to estimate of optimal dose and pharmacokinetics of oral UFT/LV after liver resection for liver metastasis of colorectal cancer.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Optimal dose
Key secondary outcomes
Adverse event, Overall survival, Disease free survival, Pharmacokinetics
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
| Medicine |
Interventions/Control_1
Oral administration of Tegaful/Uracil 200-300mg/m2/day and leucovorin 75mg/day for 5 course (5 weeks of administration followed by 1 week of no administration)
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 proven colorectal cancer
2.Case with liver metastasis simultaneously or
metachronously
3.No extrahepatic sites of disease
4.Curatively resected metastatic liver tumor
5.Performance status must be Eastern Cooperative
Oncology Group (ECOG) 0 or 1
6.Oral intake is possible
7.Adequate bone marrow, hepatic, renal, cardiac and
respiratory functions
8.Written informed consent
Key exclusion criteria
1.Active synchronous or metachronous malignancy other than carcinoma in situ
2.Serious postoperative complications
3.Serious coexisting illness
A) Uncontrolled diabetes mellitus
B) Uncontrolled hypertension
C) History of myocardial infarction, unstable angina within 6 months prior to the registration
D) Severe pulmonary dysfunction
E) Liver cirrhosis
4.Ascites or pleural effusion needed to 5.Positive HBs antigen
6.Bleeding, paralysis, obstruction or ulcer of
gastrointestinal tract
7.Pregnant or nursing
8.Severe mental disorders
9.Not suitable for participating in the study for any other
Reason by the physician
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Inomata |
Organization
Oita university, faculty of medicine
Division name
Gastroenterological and pediatric surgery
Zip code
Address
1-1 Hasama-machi, Yufu, Oita 879-5593, Japan
TEL
097-586-5843
geka1@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukio Iwashita |
Organization
Oita university faculty of medicine
Division name
Gastroenterological and pediatric surgery
Zip code
Address
1-1 Hasama-machi, Yufu, Oita 879-5593, Japan
TEL
097-586-5843
Homepage URL
iwashita@oita-u.ac.jp
Sponsor or person
Institute
Oita university, faculty of medicine, department gastroenterology and pediatric surgery
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2016 | Year | 02 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 11 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 22 | Day |
Last modified on
| 2017 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024395
