Colorectal Cancer Clinical Trial
Official title:
A Phase II Study Of Adjuvant Intravenous Irinotecan Following Resection With Or Without Radiofrequency Ablation (RFA), Of Hepatic Metastases From Colorectal Carcinoma
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.
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.
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