A Phase II Study Of Adjuvant Intravenous Irinotecan Following Resection With Or Without Radiofrequency Ablation (RFA), Of Hepatic Metastases From Colorectal Carcinoma
- 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
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.
Primary Purpose: Treatment
Kevin G. Billingsley, MD
University of Washington
United States: Federal Government
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|
|University of Washington School of Medicine||Seattle, Washington 98195|