UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study of optimal dose and pharmacokinetics of a Uracil/Tegafur (UFT) plus oral leucovorin regimen after liver resection for colorectal liver metastasis
Title of the study (Brief 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
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	Masafumi Inomata
Organization	Oita university, faculty of medicine
Division name	Gastroenterological and pediatric surgery
Address	1-1 Hasama-machi, Yufu, Oita 879-5593, Japan
TEL	097-586-5843
Email	geka1@oita-u.ac.jp

Public contact
Name of contact person	Yukio Iwashita
Organization	Oita university faculty of medicine
Division name	Gastroenterological and pediatric surgery
Address	1-1 Hasama-machi, Yufu, Oita 879-5593, Japan
TEL	097-586-5843
Homepage URL
Email	iwashita@oita-u.ac.jp

Sponsor
Institute	Oita university, faculty of medicine, department gastroenterology and pediatric surgery
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 11 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024395