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 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT00008294
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the colon or rectum with unresectable liver metastases that comprise less than 70% of liver parenchyma
* No extrahepatic disease
* No ascites
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* Karnofsky 60-100%
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
* No hepatic encephalopathy
Renal:
* Creatinine no greater than 1.5 mg/dL
Other:
* Not pregnant or nursing
* Negative pregnancy test
* No obstruction of gastrointestinal tract or genitourinary tract
* No symptomatic peripheral sensory neuropathy
* No active infection
* No other malignancy except resectable primary colorectal carcinoma
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior floxuridine
* If undergoing cryosurgery (group I cryosurgery closed to accrual as of 10/13/03), must have received one of the following:
* Systemic chemotherapy for metastatic disease
* Adjuvant therapy within the past 6 months comprising fluorouracil with or without levamisole for resected primary colorectal carcinoma
* Adjuvant therapy within the past 12 months comprising fluorouracil and leucovorin calcium with or without levamisole for resected primary colorectal carcinoma
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy to liver
Surgery:
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00008294
Study Brief:
Protocol Section:
NCT00008294