UMIN-CTR Clinical Trial

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

Liver resection for liver metastasis of colorectal cancer

Classification by specialty

Gastrointestinal surgery

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Optimal dose

Key secondary outcomes

Adverse event, Overall survival, Disease free survival, Pharmacokinetics

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

geka1@oita-u.ac.jp

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

Email

iwashita@oita-u.ac.jp

Institute

Oita university, faculty of medicine, department gastroenterology and pediatric surgery

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

02

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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