Chemotherapy With or Without Isolated Hepatic Perfusion With Melphalan in Treating Patients With Colorectal Cancer That Has Spread to the Liver
NCT00020501 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2012-03-08
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 them in different ways may kill more tumor cells. It is not yet known which chemotherapy regimen is most effective for colorectal cancer that has spread to the liver.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without isolated hepatic perfusion with melphalan in treating patients who have colorectal cancer that has spread to the liver.
Conditions
Interventions
- DRUG
-
FOLFIRI regimen
- DRUG
-
floxuridine
- DRUG
- DRUG
-
irinotecan hydrochloride
- DRUG
-
leucovorin calcium
- DRUG
-
melphalan
- PROCEDURE
-
hyperthermia treatment
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
National Institutes of Health Clinical Center (CC)
lead NIH
Principal Investigators
-
H. Richard Alexander, MD, FACS · NCI - Surgery Branch
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-03-31
- Completion
- 2005-01-31
Countries
- United States
Study Locations
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