Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:11 PM
Study NCT ID:
NCT00002793
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemotherapy Via an Implantable Pump Compared With a Subcutaneous Port for Unresectable Liver Metastases in Patients With Resected Colorectal Cancer
Sponsor:
Johann Wolfgang Goethe University Hospital
Organization:
Study Overview
Official Title:
PALLIATIVE LOCAL CHEMOTHERAPY FOR NON-RESECTABLE LIVER METASTASES FROM COLORECTAL CARCINOMA, A RANDOMISED PHASE III STUDY
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 or giving the drugs in different ways may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy administered via an implantable pump with a subcutaneous port for unresectable liver metastases in patients with resected primary colorectal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy administered via an implantable pump with a subcutaneous port for unresectable liver metastases in patients with resected primary colorectal cancer.
Detailed Description:
OBJECTIVES: I. Compare the efficacy of 2 schedules of fluorouracil/leucovorin given as a continuous intra-arterial infusion via an implantable pump vs. a subcutaneous port for unresectable liver metastases in patients with colorectal cancer. II. Compare the effect of each treatment on response rate, quality of life, and rate of technical complications in these patients.
OUTLINE: Randomized study. The following acronyms are used: CF Leucovorin calcium, NSC-3590 5-FU Fluorouracil, NSC-19893 Arm I: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Weekly infusion via an implantable pump. Arm II: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Weekly infusion via a subcutaneous infusion port. Arm III: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Monthly infusion via an implantable pump. Arm IV: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Monthly infusion via a subcutaneous infusion port.
PROJECTED ACCRUAL: A total of 336 patients will be entered in this multicenter study.
OUTLINE: Randomized study. The following acronyms are used: CF Leucovorin calcium, NSC-3590 5-FU Fluorouracil, NSC-19893 Arm I: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Weekly infusion via an implantable pump. Arm II: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Weekly infusion via a subcutaneous infusion port. Arm III: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Monthly infusion via an implantable pump. Arm IV: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Monthly infusion via a subcutaneous infusion port.
PROJECTED ACCRUAL: A total of 336 patients will be entered in this multicenter study.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: