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 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT00068068
Eligibility Criteria:
Inclusion Criteria
* Patients with metastatic liver lesions from colorectal disease who have failed or progressed on a chemotherapy regimen for metastatic disease.
* Biopsy proven evidence of colorectal cancer.
* Patients with 4 or fewer lesions greater than 1 cm and with no single lesion greater than 7 cm in maximum diameter.
* Age greater than or equal to 18 years.
* Patients must be able to sign informed consent.
* Life expectancy greater than or equal to 3 months.
* ECOG performance status 0-2.
* Patients with extrahepatic disease in addition to their hepatic metastases are eligible and will receive systemic therapy for their extrahepatic disease following Litx therapy.
* Off chemotherapy for 4 weeks. Must have recovered from the chemotherapy effects.
Exclusion Criteria
Patients must be excluded if any of the following apply:
* Patients who are candidates for complete surgical resection.
* Pregnancy or breast-feeding. A negative pregnancy test (urine or serum) is required prior to enrollment.
* Known uncontrollable serious reactions such as anaphylaxis, to the contrast agents used in this study.
* PT or PTT greater than 1.5X control.
* Platelet count less than 100,000.
* WBC less than 2500/mm.
* Neutrophils less than 2000/mm.
* Hemoglobin less than 9 g/dL.
* Liver enzymes greater than 3 X ULN.
* Total bilirubin greater than 1.5 X ULN.
* Serum creatinine greater than 2.5 X ULN.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00068068
Study Brief:
Protocol Section:
NCT00068068