A Randomized, Open-label Study to Compare Propofol Anesthesia With Sevoflurane Anesthesia in Terms of Overall Survival in Patients With Surgical Intervention for Either Breast-, Colon- or Rectal Cancer

The study will be completed in accordance with Declaration of Helsinki, Good Clinical Practice (GCP) and applicable regulatory requirements. The study will include approximately 8,000 pts from about 10 sites in Sweden and probably also from one or two international sites. The population will be pts that are scheduled for radical breast- or colorectal cancer surgery in general anesthesia with or without additional regional anesthesia.

A clinically relevant absolute difference in five-year-survival would be 5%. Based on data from our retrospective study, we will have 80% power to detect a difference of 5% with a P-value of <0.05 if including 7,378 pts (see below). By adding 8.4% more to the inclusion, we will have a reasonable safety margin for loss of pts or technical errors.

Breast cancer, expected 5-year survival of 87% vs 82%: 1,650 pts Colon cancer, expected 5-year survival of 60% vs 55%: 3,000 pts Rectal cancer, expected 5-year survival of 70% vs 65%: 2,728 pts Margin for loss of patients or technical errors 622 pts Total 8,000 pts.

During the preoperative anesthetic procedures, the pts will be screened and consented for the study. Demographic data will be collected in connection with screening/enrolment. The pts will be randomized to either propofol- or sevoflurane anesthesia.

The only study specific procedure for this protocol is the randomization. The products used in this study are well established and registered since many years. The manufacturers of the products used are responsible for safety monitoring for pharmacovigilance purposes according to regulations.