Radiofrequency Ablation Followed By Hepatic Artery Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver
NCT00004142 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2018-10-26
Summary
RATIONALE: Radiofrequency ablation may be able to shrink or destroy cancer cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemotherapy delivered directly into the blood vessels of the liver may prevent new tumors from growing. Combining these therapies may be an effective treatment for colorectal cancer that has spread to the liver.
PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation followed by chemotherapy delivered directly into the blood vessels of the liver in treating patients who have colorectal cancer that has spread to the liver.
Conditions
Interventions
- DRUG
-
Floxuridine
Part of hepatic arterial chemotherapy on days 1-7. Treatment repeats every 5 weeks for 6 courses.
- DRUG
-
Fluorouracil (5-FU)
Part of hepatic arterial chemotherapy over 1 hour on days 15, 22, and 29. Treatment repeats every 5 weeks for 6 courses.
- PROCEDURE
-
Conventional surgery
Open laparotomy to identify target tumor in liver using intraoperative ultrasound.
- PROCEDURE
-
Radiofrequency ablation
Radiofrequency tissue ablation over 20 minutes to each tumor.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Lee M. Ellis, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1998-08-05
- Primary Completion
- 2003-12-09
- Completion
- 2003-12-09
Countries
- United States
Study Locations
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