UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004095
Receipt number R000004930
Scientific Title Research of pharmacokinetic and pharmacogenetic determinants of the activity and toxicity of 5-Fluorouracil in colorectal cancer patients
Date of disclosure of the study information 2010/08/24
Last modified on 2014/08/27 09:52:25

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Basic information

Public title

Research of pharmacokinetic and pharmacogenetic determinants of the activity and toxicity of 5-Fluorouracil in colorectal cancer patients

Acronym

Research of biomarkers associated with 5-FU

Scientific Title

Research of pharmacokinetic and pharmacogenetic determinants of the activity and toxicity of 5-Fluorouracil in colorectal cancer patients

Scientific Title:Acronym

Research of biomarkers associated with 5-FU

Region

Japan


Condition

Condition

Colorectal cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To explore predictive biomarkers for 5-FU pharmacokinetics.

Basic objectives2

Pharmacodynamics

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

To evaluate the relationship between 5-FU pharmacokinetics and plasma biomarkers.

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Histologically confirmed colorectal cancer
2) Patient who is intended to receive chemotherapy with continuously infused 5-fluorouracil
3)20 years of age or older
4)Performance Status (ECOG) 0-2
5)Adequate organ function obtained within 2 weeks prior to registration. Laboratory values must be as follows;
WBC count >= 3,000 /mm3
absolute neutrophil count >= 1,500 /mm3
platelet count >= 100,000 /mm3
hemoglobin >= 7.0 g/dL
AST/ALT/ALP <= 2.5 X institutional upper limit of normal
Total bilirubin less than or equal to 2.0 mg/dL
serum creatinine within 2.0 times the upper limit of normal
6) Signed informed consent

Key exclusion criteria

1) Hoped to be pregnant/nursing.
2) Allergy to fluoropyrimidine compounds
3) Simultaneous use of other fluoropyrimidine drugs
4) History of severe complicating disease
5) Active infection
6) History of bone-marrow transplantation
7) Those who received a white blood cell transfusion within 30 days before registration
8) Those judged to be not suitable by the attending physician

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ichiro Ieiri

Organization

Graduate school of Pharmaceutical Science, Kyushu University

Division name

Department of clinical pharmacokinetics

Zip code


Address

Maidashi 3-1-1, Higashi-ku, Fukuoka city

TEL

092-642-6657

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yoshimasa Shiraishi

Organization

Graduate school of Pharmaceutical Science, Kyushu University

Division name

Department of clinical pharmacokinetics

Zip code


Address

Maidashi 3-1-1, Higashi-ku, Fukuoka city

TEL

092-642-6659

Homepage URL


Email

shiraish@kokyu.med.kyushu-u.ac.jp


Sponsor or person

Institute

Department of clinical pharmacokinetics, Graduate school of Pharmaceutical Science, Kyushu University

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

Department of Hematology and Oncology, Kyushu University Hospital

Name of secondary funder(s)



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

九州大学病院 血液腫瘍内科


Other administrative information

Date of disclosure of the study information

2010 Year 08 Month 24 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

Terminated

Date of protocol fixation

2010 Year 06 Month 10 Day

Date of IRB


Anticipated trial start date

2010 Year 08 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Blood samples are serially collected from colorectal cancer patients before and during 5-FU continuous infusion.
Relationship between 5-FU pharmacokinetics and polymorphisms are assessed.


Management information

Registered date

2010 Year 08 Month 24 Day

Last modified on

2014 Year 08 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004930


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name