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
Swiss Cancer Institute
OBJECTIVES: * Compare the efficacy of capecitabine and oxaliplatin with vs without cetuximab in patients with epidermal growth factor receptor-positive metastatic unresectable colorectal cancer. * Compare the objective response (complete and partial response) in patients treated with these regimens. Secondary * Compare the safety of these regimens in these patients. * Compare the clinical benefit (complete response, partial response, or stable disease for at least 18 weeks) in patients treated with these regimens. * Compare overall survival, time to progression, and time to treatment failure in patients treated with these regimens. OUTLINE: This is a multicenter, randomized study. Patients are stratified according to performance status (0 vs 1), type of metastases (synchronous vs metachronous), prior adjuvant chemotherapy (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral capecitabine twice daily on days 1-15 and oxaliplatin IV over 2 hours on day 1. * Arm II: Patients receive capecitabine and oxaliplatin as in arm I and cetuximab IV over 1-2 hours on days 1 and 8. In both arms, courses repeat every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients will be followed every 3 months for 1 year and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 74 patients (37 per treatment arm) will be accrued for this study within 1.5 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
