Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
PRIMARY OBJECTIVES: I. Determine the efficacy and toxicity of neoadjuvant and adjuvant capecitabine and oxaliplatin in patients with resectable liver metastases secondary to colorectal cancer who are undergoing surgery. II. Determine the rates of R0 resection in patients treated with this regimen before surgery. SECONDARY OBJECTIVES: I. Determine the response rate in patients treated with this regimen. II. Determine the resectability in the subsets of patients defined as resectable preoperatively and treated with this regimen. III. Determine improvement in survival associated with downstaging based on metastatic colorectal prognostic score in patients treated with this regimen. IV. Determine the disease-free and overall survival of patients treated with this regimen. V. Correlate drug-specific biomarkers with clinical response in patients treated with this regimen. OUTLINE: This is a multicenter study. Neoadjuvant chemotherapy: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Surgery: Four to six weeks after the completion of chemotherapy, patients undergo surgical resection of the tumor. Adjuvant chemotherapy: Patients with satisfactory response to therapy receive 4 additional courses of oxaliplatin and capecitabine after surgery. Patients are followed at 4-6 weeks after surgery, every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A maximum of 80 patients will be accrued for this study.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
