Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002793
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
1999-11-01
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:
National Cancer Institute NCI
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 fluorouracilleucovorin 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:
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-96007 | None | None | None |
| GER-ALM-0395 | None | None | None |