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PHASE III STUDY OF HEPATIC ARTERY FLOXURIDINE (FUDR), LEUCOVORIN (LV), AND DEXAMETHASONE (DEX) VERSUS SYSTEMIC 5-FLUOROURACIL (5-FU) AND LEUCOVORIN (LV) AS TREATMENT FOR HEPATIC METASTASES FROM COLORECTAL CANCER
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 may kill more cancer cells. It is not yet known which chemotherapy regimen is more effective for metastatic colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of intrahepatic floxuridine, leucovorin, and dexamethasone with that of systemic fluorouracil and leucovorin in treating patients who have unresectable liver metastases from colorectal cancer.
Details
| Lead sponsor | Alliance for Clinical Trials in Oncology |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 135 |
| Start date | 1996-01 |
| Completion | 2006-08 |
Conditions
- Colorectal Cancer
- Metastatic Cancer
Interventions
- dexamethasone
- floxuridine
- fluorouracil
- leucovorin calcium
- laparotomy
- conventional surgery
Primary outcomes
- Overall survival — Up to 5 years
- Time to progression — Up to 5 years
Countries
United States, Australia, Peru, Puerto Rico