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:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-26 @ 12:14 PM
NCT ID:
NCT02350400
Eligibility Criteria:
Inclusion Criteria:
1. Metastatic colorectal carcinoma to the liver, both unilobar and bilobar disease
2. Refractory to 1st or 2nd line systemic chemotherapy. Previous chemotherapy had to be discontinued at least 4 weeks prior to study entry
3. Hepatic disease should be 80% or more of total body tumor burden
4. Measurable liver tumour burden was of no more than 60% of the total liver volume.
5. A performance status of 0-2 (WHO criteria).
6. Age \<85 years were required.
7. Life expectancy of greater than 3 months
8. Adequate hematologic function (granulocyte count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, INR ≤ 1.3 in patients on anticoagulant therapy)Adequate hepatic function (total bilirubin ≤ 1.5 x the upper limits of normal \[ULN\], AST and ALT ≤ 5 x ULN, and alkaline phosphatases \< 5 x ULN) and,
9. Adequate renal function (creatinine clearance \> 50 mL/min)
Exclusion Criteria:
1. Extrahepatic tumor burden of \> 20%.
2. Patients with unilobar disease who are candidates for surgical resection.
3. Extensive tumor involvement of the liver (\>60%)
4. Poor performance status (\>2 WHO criteria)
5. Significant diseases of cardiac, renal, bone marrow or pulmonary apparatus, central nervous system involvement, and uncontrolled infection
6. Liver function tests and bilirubin 5-folds more than the normal value
7. History of other cancer except adequately treated in situ carcinoma of the cervix or basal or squamous carcinoma of the skin
8. Absolute neutrophil count of less than 1500 cells/µL
9. Platelet count of less than 100,000/µL
10. Significant portal vein thrombosis
11. Unable to understand nature of study and provide written consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02350400
Study Brief:
Protocol Section:
NCT02350400