Evaluation of chemotherapy efficacy and toxicity of 5-Fluoruracil by coventional dosage and pharmcokinetic dosig for Chinese gastrointestinal patients.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-14004328

Enrollment

Unknown

Registered

2014-02-25

Start date

2014-03-10

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

gastric cancer / colorectal cancer

Interventions

BSA:clinical experience

PK:clinical experience

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-75 years old; 2. Patients who are with gastric cancer, colorectal cancer, has not been got surgery yet or physical condition has not been acceptable, but not suitable for surgery; laparoscopy, histology, cytology or radiologic confirmation of advanced or late gastric cancer and colorectal cancer; 3.ECOG score = 2 points, KPS score = 60;4 .the coming chemotherapy containing 5-FU; According to RECIST 1.1 criteria, patients must be at least one measurement of lesions (non lymphadenopathy measuring diameter, lymph node lesions in short diameter measurement date), the general requirements of CT measurable lesion diameter greater than 20mm, spiral CT or MRI measurable lesions required diameter than 10mm; 6. Expected survival of more than three months; 7. with normal bone marrow metabolism and major organ function: 8. Subjects were enrolled into this study and signed an informed consent form, good compliance with follow-up; 9. All patients regardless of gender and race may join the study.

Exclusion criteria

Exclusion criteria: 1. Had got radiotherapy or chemotherapy 4 weeks ago (6 weeks or had used nitrosoureas and mitomycin drugs), or had got treatment 4 weeks ago but not recover from adverse reaction; 2. in the use of other experimental drugs in chemotherapy; 3. with brain metastases; 4. Allergy tests are positive of used chemotherapy drugs; 5. While taking other drugs that degrade by CYP2C9 enzyme such as carvedilol, succinylcholine, fosphenytoin, fluoxetine, phenytoin, warfarin et al; 6. out the control of acute infection, heart failure, unstable angina, unstable arrhythmia, or mental illness patients; 7. Pregnant or lactating women; 8. HIV positive patients.

Design outcomes

Primary

Measure	Time frame
CR/PR/PD;	—

Secondary

Measure	Time frame
tumor marker;	—

Countries

China

Contacts

Public ContactXiaoke Hao

PLA Institute of Laboratory Medicine, Xijing Hospital, the Fourth Military Medical University

haoxkg@fmmu.edu.cn+86 029-84775457

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026