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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008852

Enrollment

Registered

2012-09-04

Start date

2012-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Interventions

capecitabine

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

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

Countries

Japan

Contacts

Public ContactKatsuya Makihara

Osaka National Hospital Department of Pharmacy

katsuya@onh.go.jp06-6942-1331

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026