SCOT – Short Course Oncology Therapy – A Study of Adjuvant Chemotherapy in Colorectal Cancer v1

Design: Phase III, randomised controlled, two arm, open label, multicentre, non-inferiority. Objectives: Assessment of the efficacy of 12 weeks versus 24 weeks of treatment and associated toxicity. Economic analysis of the cost effectiveness of the 2 arms. Comparison of 2 randomisation methodologies. Endpoints: Primary Endpoint: • Disease free survival Secondary Endpoints: • Overall survival • Cost-effectiveness • Toxicity • Quality of Life Study population: 6087 patients with fully resected high-risk stage II or fully resected stage III colorectal cancer.