ABSTRACT
I. BACKGROUND The sequential procedure discussed in this chapter was applied to a phase III trial for patients with advanced colorectal cancer. The trial was conducted by the North Central Cancer Treatment Group and the Mayo Clinic. To be eligible for the study, a patient had to have histological or cytological confirmation of unresectable or metastatic colorectal cancer. The study was initiated in 1983, at which time the standard regimen for these patients was 5FU alone, as various combination regimens had failed to result in an improvement in survival in earlier trials. The median survival for this group of patients was approximately 6 months with very few patients surviving beyond 2 years.
