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:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT00313859
Eligibility Criteria:
Inclusion Criteria:
1. Histologically or cytologically confirmed metastatic colorectal cancer
2. Age ≥ 18
3. ECOG performance status 0 - 2
4. At least one measurable lesion
5. Minimum life expectancy of 12 weeks
6. Adequate bone marrow reservoir (ANC ≥ 1500/㎕, platelet ≥ 100,000/㎕)
7. Adequate renal function (serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 50 min/ml)
8. Adequate liver functions (serum bilirubin ≤ 1.5 mg/dl, AST/ALT ≤ 3 times upper normal limits)
9. No prior lipid-lowering therapy with statins less than 1 year before study entry
10. No prior chemo- or immunotherapy for metastatic CRC (adjuvant chemotherapy or chemoradiation therapy more than 6 months before study entry is permitted)
11. Written informed consent
Exclusion Criteria:
1. Active infection requiring antibiotics therapy
2. Pregnancy and/or lactation
3. Other serious illness or medical condition not appropriate for chemotherapy, especially cardiovascular disease
4. Metastatic brain lesions
5. Receipt of radiotherapy within 2 weeks before the initiation of study treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00313859
Study Brief:
Protocol Section:
NCT00313859