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 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT00023868
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic colorectal adenocarcinoma
* Measurable metastasis to liver at least 1.0 cm
* Less than 75% of total liver volume
* Known extrahepatic disease limited to lymph nodes and less than 2 cm
* No ascites
* Ineligible for surgery
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Zubrod 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute granulocyte count at least 2,000/mm\^3
* Platelet count at least 90,000/mm\^3
* No bleeding diathesis not correctable by standard therapy
Hepatic:
* Ineligible if all of the following criteria are concurrently present:
* High risk of hepatic failure (more than 50% liver involvement by tumor)
* Bilirubin greater than 2.0 mg/dL
* SGOT greater than 100 U/L
* Lactate dehydrogenase greater than 425 U/L
* No hepatic encephalopathy
* No portal vein occlusion without hepatopedal collateral flow demonstrated by angiography
* No portal hypertension with hepatofugal flow
Renal:
* Creatinine no greater than 2.0 mg/dL
Cardiovascular:
* No myocardial infarction within the past 6 months
* No evidence of congestive heart failure
* No severe peripheral vascular disease that would preclude catheterization
Other:
* No severe allergy or intolerance to contrast media, narcotics, sedatives, or atropine
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No more than 1 prior adjuvant immunotherapy regimen for colon cancer
Chemotherapy:
* At least 6 months since prior adjuvant chemotherapy and recovered
* No more than 1 prior adjuvant chemotherapy regimen for colon cancer
* No prior hepatic arterial infusion chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 1 month since prior radiotherapy
* No prior hepatic radiotherapy
Surgery:
* At least 1 month since prior surgery
* Prior surgical resection or ablation of liver metastases allowed
Other:
* No other concurrent therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00023868
Study Brief:
Protocol Section:
NCT00023868