by Eddy RempelMay 13, 2005 SOSGSSD 2005.ppt

Power Considerations in the “Quality Initiative in Rectal Cancer” Trial Design TME – Total Mesorectal Excision x-ray Summary ICC has a huge impact on Power and hence on required sample size Key parameters to calculate sample size must be estimated, i.e. r and p for these outcomes has not been published Grant reviewers demand 2-sided until the direction of effect is well established Room for more work in applying these in medical research Acknowledgements Marko Simunovic MPH, FRCS(C)1,2,3 Charlie Goldsmith, PhD2 1. Departments of Surgery, McMaster University 2. Clinical Epidemiology and Biostatistics, McMaster University 3. Juravinski Cancer Centre, Hamilton Health Sciences Approximating Binomial with Normal Approximating Binomial with Normal Approximating Binomial with Normal Approximating Binomial with Normal * by Eddy Rempel May 13, 2005 SOSGSSD 2005 Research on TME QIRC Trial Factors impacting power Sample Size Calculations Presentation Outline Refinement of rectal cancer surgery Removal of lymph node bearing tissue Retains autonomic nerves preserving bowel, bladder, and sexual function Reduces need for radiation and chemotherapy Great patient outcomes in Europe 5000 rectal cancers diagnosed in Ontario per year Motivation for Total Mesorectal Excision (TME) Research Rectal Cancer Patient Back View Visceral Fascia Parietal Fascia Seminal Vesicles ? ? ? MacFarlane JK, Ryall RD, Heald RJ. Mesorectal excision for rectal cancer. Lancet 1993; 341(8843):457-460. SRCT. N Engl J Med 1997; 336(14):980-7. Kapiteijn E, et al. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. N Engl J Med 2001; 345(9): 638-46. 13.5% 11.5% 27% 5% 4.1% 11% England Netherlands Sweden Surgery + Chemo + Radiation TME TME Recurrence Rates in Europe: TME versus Conventional Surgery 6.1% 17.1% Permanent colostomy 2.6% 17.1% Number of local recurrences No Radiation (N=115) Radiation (N=35) Basingstoke Medical Centre Simonovic M,