Clinical Trials Directory

Trials / Unknown

UnknownNCT00002793

Chemotherapy Via an Implantable Pump Compared With a Subcutaneous Port for Unresectable Liver Metastases in Patients With Resected Colorectal Cancer

PALLIATIVE LOCAL CHEMOTHERAPY FOR NON-RESECTABLE LIVER METASTASES FROM COLORECTAL CARCINOMA, A RANDOMISED PHASE III STUDY

Status
Unknown
Phase
Phase 3
Study type
Interventional
Enrollment
336 (estimated)
Sponsor
Johann Wolfgang Goethe University Hospital · Academic / Other
Sex
All
Age
18 Years – 76 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
DRUGfluorouracil
DRUGleucovorin calcium

Timeline

Start date
1991-01-01
First posted
2004-09-02
Last updated
2013-09-17

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT00002793. Inclusion in this directory is not an endorsement.