Poster Presentation Clinical Oncology Society of Australia 2014 Annual Scientific Meeting

A phase III study of the impact of a physical activity program on disease-free survival in patients with high-risk stage II or stage III colon cancer: A randomized controlled trial (NCIC CTG CO.21) (#446)

Brandi Baylock 1 , Haryana M. Dhillon 1 , K. Courneya 2 , C. O'Callaghan 2 , A. O'Brien 2 , A. M. Goddard 1 , J. Turner 1 3 , M. Kabourakis 1 , H. Rice 1 , S. Begbie 4 , P. Williams 4 , S. Ackland 5 , C. Fischer 5 , L. Chantrill 6 , D. Vandine 6 , R. Ashgari 7 , M. Hoque 7 , M. Burge 8 , D. Hickey 8 , S. Della-Fiorentina 9 , S. Ellul 9 , J. L. Vardy 1 3
  1. Centre for Medical Psychology & Evidence- based Decision-making, Central Clinical School, Sydney Medical School, The University of Sydney, Sydney, NSW, Australia
  2. NCIC Clinical Trials Group, Sydney, NSW, Australia
  3. Concord Cancer Centre, Concord Repatriation General Hospital, Concord, NSW, Australia
  4. North Coast Cancer Institute, Port Macquarie, NSW, Australia
  5. Newcastle Private Hospital, Newcastle, NSW, Australia
  6. Campbelltown Hospital, Campbelltown, NSW, Australia
  7. Bankstown Lidcombe Hospital, Bankstown, NSW, Australia
  8. Royal Brisbane & Women’s Hospital, Brisbane, QLD, Australia
  9. Southern Highlands Cancer Centre, Illawara, NSW, Australia

Purpose: Observational studies indicate that physical activity (PA) is associated with colon-cancer specific survival. The NCIC CTG CO.21 (CHALLENGE) trial is designed to determine the effects of a structured PA intervention on disease-free survival in high-risk stage II or III colon cancer survivors who have completed adjuvant chemotherapy within the previous 2-6 months.

Methods: Phase III randomized controlled trial. Target sample size of 962 patients is powered to detect a Hazard Ratio of 0.75 for disease-free survival (DFS). Trial participants are stratified by centre, disease stage, body mass index, and performance prior to randomization to a structured PA intervention or general health education materials. The PA intervention consists of a behavioural support program and supervised PA sessions delivered over a 3-year period, beginning with regular face-to-face sessions and tapering to less frequent face-to-face or telephone sessions. The goal of the PA program is to increase weekly PA by 10 MET hours/week.  The PA program is delivered by physical activity consultants trained in exercise physiology and behavior change.

Outcomes: The primary endpoint is DFS. Important secondary endpoints include multiple patient-reported outcomes (including those that address fatigue), objective physical functioning, biologic correlative markers (including assessment of the insulin pathway), and an economic analysis. Data is also being collected on motivational outcomes and behavior change that will inform program delivery.

Current Enrollment: The study is open at 20 centers in Canada and 26 centers in Australia and will open in other countries in 2014. Accrual as of August 12, 2014 includes 357 registered and 310 randomized patients.

Summary: Cancer survivors and cancer care professionals are interested in the potential role of PA to improve disease-free survival and quality of life, but a randomized controlled trial is needed to provide compelling evidence to justify changes in health care policies and practice.