Surgery With or Without Radiofrequency Ablation Followed by Irinotecan in Treating Patients With Colorectal Cancer That is Metastatic to the Liver
- Conditions
- Colorectal CancerMetastatic Cancer
- Registration Number
- NCT00030563
- Lead Sponsor
- University of Washington
- Brief Summary
RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Combining radiofrequency ablation with surgery may kill more tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug after surgery and radiofrequency ablation may kill any remaining tumor cells.
PURPOSE: Phase II trial to determine the effectiveness of surgery with or without radiofrequency ablation followed by irinotecan in treating patients who have colorectal cancer that is metastatic to the liver.
- Detailed Description
OBJECTIVES:
* Determine the disease-free survival in patients with hepatic metastases from primary colorectal carcinoma treated with surgical resection with or without radiofrequency ablation followed by irinotecan.
* Determine the overall survival in patients treated with this regimen.
* Determine the treatment-related toxicity of this regimen in these patients.
* Correlate the measurement of molecular markers with clinical outcome in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to treatment with radiofrequency ablation in addition to resection (yes vs no).
Patients undergo surgical resection with or without radiofrequency ablation. Beginning 4-8 weeks after surgery, patients receive irinotecan IV over 90 minutes on day 1. Chemotherapy repeats every 3 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
University of Washington School of Medicine
🇺🇸Seattle, Washington, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada