Intravenous Compared With Intrahepatic Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
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|ClinicalTrials.gov Identifier: NCT00002692|
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : May 21, 2004
Last Update Posted : December 19, 2013
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 tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of intravenous infusion or intrahepatic infusion of fluorouracil and leucovorin in treating patients with colorectal cancer metastatic to the liver.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic Cancer||Drug: fluorouracil Drug: isolated perfusion Drug: leucovorin calcium||Phase 3|
OBJECTIVES: I. Compare the survival and response rates of patients with colorectal liver metastases treated with intravenous vs. intrahepatic arterial infusion of fluorouracil/leucovorin. II. Assess the effect of these 2 treatments on symptoms and quality of life of these patients.
OUTLINE: Randomized study. Patients randomized to Arm II should have a preoperative hepatic angiography; at laparotomy, an intrahepatic arterial catheter is fused into the gastroduodenal artery to establish an infusion of both lobes of the liver. Arm I: Single-Agent Chemotherapy with Drug Modulation. Fluorouracil, 5-FU, NSC-19893; with Leucovorin calcium, CF, NSC-3590. Intravenous infusion. Arm II: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Intrahepatic arterial infusion.
PROJECTED ACCRUAL: 312 patients are expected to be randomized within 3-4 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||312 participants|
|Official Title:||A RANDOMISED TRIAL OF INTRAVENOUS VERSUS INTRAHEPATIC ARTERIAL 5-FU AND LEUCOVORIN FOR COLORECTAL LIVER METASTASES|
|Study Start Date :||December 1994|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002692
|Birmingham, England, United Kingdom, B15 2TT|
|Study Chair:||David J. Kerr, MD, FRCP, DSc||University Hospital Birmingham|