At a glance
ClinicalIndex Comparison Record- ✓Histologically or radiologically confirmed colorectal carcinoma with intrahepatic metastases
- ✓No more than 15 intrahepatic metastases involving ≤60% of functioning liver
- ✓Age 18–70 years
- ✓Karnofsky performance status 60–100%
- ✕Extrahepatic disease unless resectable (anastomotic/locally recurrent tumor, mesenteric nodes, or amenable to en bloc resection with liver)
- ✕Biopsy-proven chronic active hepatitis
- ✕Second malignancy within 5 years (except nonmelanomatous skin cancer, in situ bladder cancer, or in situ cervical cancer)
- ✕Prior radiotherapy to the liver
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Hepatic Resection Followed by Concurrent Adjuvant Portal Vein Infusion of Fluorodeoxyuridine and Systemic 5-Fluorouracil and Folinic Acid for Metastatic Colorectal Carcinoma
In Brief
A Phase 2 clinical trial evaluating floxuridine, fluorouracil, and 3 other interventions for Colorectal Cancer and Metastatic Cancer. Completed, enrolled 49 participants across 1 site.
Detailed Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of surgery followed by floxuridine plus systemic fluorouracil and leucovorin in treating patients with liver metastases from colorectal cancer.
Study Details
Timeline
Interventions
Starting dose of 0.2 mg/kg/day for 14 consecutive days.
300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days.
500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU.
Chemotherapy given after hepatic resection
Hepatic resection