Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT00155558
Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed recurrent or metastatic colorectal adenocarcinoma
* Patients are indicated for 5-FU (1st-line after recurrence/metastasis), OR have failed 5-FU ,treatment with other schedules
* At least one bi-dimensionally measurable lesion(s)
* Previous C/T, R/T \>= 4 weeks
* KPS \> 50%
* Age \>= 18 years
* Fasting TG \> 70 mg/dL (within 7 days)
* WBC \>= 3,000/uL or ANC \>= 1,500/uL
* Plt \>= 75,000/uL
* Cre\<= 1.5 mg/dL
* Proteinuria \< 1+
* Normal T-bil
* AST/ ALT \<= 3.5-fold of ULN
Exclusion Criteria:
* Concomitant anticancer therapy or radiotherapy
* CNS metastasis
* Pregnant women
* Patients who have second malignancy
* Symptomatic heart disease (significant arrhythmia, CHF or MI within 3 months of entry)
* Active infection exists
* Extensive liver disease or liver cirrhosis
* Patients who refuse Port-A catheter implantation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00155558
Study Brief:
Protocol Section:
NCT00155558