UMIN-CTR Clinical Trial

Public title

Personal dose monitoring of fluorouracil and metabolites of capecitabine(XELODA)in patients with colorectal cancer patients (PersonaX)

Acronym

PersonaX

Scientific Title

Personal dose monitoring of fluorouracil and metabolites of capecitabine(XELODA)in patients with colorectal cancer patients (PersonaX)

Scientific Title:Acronym

PersonaX

Region

Japan

Condition

Colorectal Cancer

Classification by specialty

Medicine in general	Gastroenterology	Hepato-biliary-pancreatic medicine
Surgery in general	Gastrointestinal surgery	Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the correlation of plasma components (5-FU measured by My5-FU, 5'-DFCR and 5'-DFUR) and adverse events in Japanese colorectal cancer patients treated with oral capecitabine.

Basic objectives2

Pharmacokinetics

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The correlation between the capecitabine dose and the C1 and C2 levels of 5-FU, unchanged capecitabine, 5'-DFCR, 5'-DFUR in the blood. C1=concentration an hour after administration of capecitabine
C2=concentration two hours after administration of capecitabine.

Key secondary outcomes

(1)concentration/dose (C/D) ratio
(2)the evaluation of adverse events
(3)renal function and adverse events

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

Prevention

Type of intervention

Medicine

Interventions/Control_1

capecitabine

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Histologically confirmed colorectal cancer.
2. No prior capecitabine.
3. Patients treated with capecitabine with or without oxaliplatin and/or molecular-targeted agents.
4. Capecitabine dose:2,000mg/m2/day.
5. Age of at least 20 yaers.
6. ECOG PS of 0 or 1.
7. A life expectancy of more than 3 months.
8. Written informed consent.
9. Adequate function of vital organs, including normal hematopoietic, liver and renal function:
1)White blood cell count >=3,000/mm3 and <=12,000/mm3
2)Platelets>=75,000/mm3
3)Aspartate aminotransferase levels <=100IU/I (200IU/I in case of liver metastasis)
4)Alanine aminotransferase levels <=100IU/I (200IU/I in case of liver metastasis)
5)Total bilirbin >=1.5mg/dl
6)Serum creatinine level:less than 1.2mg/dl

Key exclusion criteria

1. Severe nfection.
2. Uncontrolled diarrhea.
3. Bowel obstruction.
4. Interstitial pneumonia or pulmonary fibrosis.
5. Pleural effusion, ascites and pericardial fluid.
6. Severe comorbidity(renal failure, hepatic failure, hypertension)
7. History of myocardial infarction within 6 months.
8. Liver cirrhosis
9. Active bowel bleeding.
10. Uncontrollable diabetes.
11. Active multiple cancer.
12. Suspected to be dihydropyrimidine dehydrogenase (DPD) deficiency.
13. Receiving theophylline
14. Pregnant or possibly pregnant, and nursing women.
15.Other conditions not suitable for this study.

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Hideyuki Mishima

Organization

Aichi Medical University

Division name

Cancer Center

Zip code

Address

1-1,Yazakokarimata,Nagakute,Aichi,480-1195

TEL

06-6942-1331

Email

hmishima@aichi-med-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Katsuya Makihara

Organization

Osaka National Hospital

Division name

Department of Pharmacy

Zip code

Address

2-1-14,Hoenzaka,Chuo-ku,Osaka,540-0006

TEL

06-6942-1331

Homepage URL

Email

katsuya@onh.go.jp

Institute

Osaka National Hospital

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

2012

Year

09

Month

04

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

Completed

Date of protocol fixation

2012

Year

02

Month

20

Day

Date of IRB

Anticipated trial start date

2012

Year

03

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

09

Month

04

Day

Last modified on

2018

Year

09

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010139