colorectal cancer
Conditions
Interventions
group of dosing adjusted by TDM:adjusted dose of 5-Fu by TDM
group of dosing adjusted by BSA:adjusted dose of 5-Fu by BSA
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients histopathologically diagnosed as colorectal cnacer will be inclued: for the early diagnosed patients, they should not received any chemotherapy; for the terminal cancer patients, they should not received any palliative chemotherapy and their adjuvant chemotherapy should finished more than 1 year; 2. They are 18~70 years old; 3. Their weight must over 45 kg; 4. 0~1 of ECOG; 5. They could fulfill 4 cycles chemotherapy; 6. They have normal organ function: (1) Without bleeding tendency; (2) routine blood test: 1) Hb>=90g/L; 2) WBC>=4.0*10^9/L; 3) ANC>=2.0*10^9/L; 4) PLT>=100*10^9/L. (3) liver function, biochemistry test: 1) Both ALT and AST<=1.5*ULN; 2) TBIL<=1.5*ULN; 3) Ccr<=1.5*ULN. 4. Without dysfunction of heart or lung; 5. Women of childbearing age should receive pregnancy test in 7 days before entering the group(blood or urine) and have negative results. Furthermore, they should adopt appropriate contraceptive method; 6. They should obey the project as judged by the researcher; 7. They volunteer this clinical trial by themselves and understand the research project. So they signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. The women in pregnancy or lactation; 2. The patients received chemotherapy containing 5-Fu or capecitabine4 weeks before being included; 3. patients with acute, active infection, or received therapy of systematic anti-infection within 72 h; 4. patients with history of bone marrow or ?stem cell transplantation, and other hematological disease influencing the hematopoietic function of bone marrow; 5. patients with sever concomitant diseases which will influence the patients' safety or the completing of the research judged by the researchers; 6. patients took part in other drug's clinical trial in the past 4 weeks; 7. patients having an allergy to 5-Fu; 8. patients with history of drug abuse; 9. patients with other conditions not inadequacy to this research judged by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OR;blood concentration of 5-Fu; | — |
Countries
China
Contacts
Public ContactHongxia Wang
Outcome results
None listed