Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002692
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Intravenous Compared With Intrahepatic Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A RANDOMISED TRIAL OF INTRAVENOUS VERSUS INTRAHEPATIC ARTERIAL 5-FU AND LEUCOVORIN FOR COLORECTAL LIVER METASTASES
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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
Detailed Description:
OBJECTIVES I Compare the survival and response rates of patients with colorectal liver metastases treated with intravenous vs intrahepatic arterial infusion of fluorouracilleucovorin 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-95032 | None | None | None |
| MRC-CR05 | None | None | None |