Supporting the Canadian arm of the ME15 international trial Wednesday, February 19, 2020 CCTG has been awarded $1,303,560 from the Fall 2019 CIHR Project Grant competition, a program that helps advance health-related research. The funds will support the Canadian contribution to the ME15 international trial, investigating use of smaller surgical margins to reduce the extent of surgery in Stage 2 melanoma patient - Larger margins result in disfigurement, wound discomfort, and time away from work and, if positive, will change practice in Canada and around the world. Dr. Janet Dancey has worked closely with the ME15 Principle Investigator, Dr. Frances Wright Researcher, Surgical oncologist at Sunnybrook and Professor of Surgery at University of Toronto, to secure the funding that will bring this trial to Canada. The international study is referred to as MelMarT-II and is led by Melanoma and Skin Cancer Trials (MASC), an Australian and New Zealand Collaborative Clinical Trials Group that is focused on investigator-led clinical trials for melanoma and skin cancers. About Dr. Frances Wright The ME15 Principal Investigator, Dr. Frances Wright is involved in knowledge translation and getting best evidence into practice, particularly in the area of cancer surgery. Her Clinical research revolves around choices women make with breast cancer surgery and outcomes for patients with melanoma. About the ME15 trial The incidence of melanoma is increasing worldwide. In 2019, 7800 Canadians will be diagnosed and 1300 will die from melanoma. Wide local excision (WLE) around the primary melanoma and a sentinel lymph node biopsy is standard treatment. The thickness (or depth) of the melanoma determines the extent of the WLE. Randomized trials to date have progressively confirmed the safety and effectiveness of reduced margins, but there is no randomized evidence comparing 1 versus 2cm margins for patients with clinical stage II melanoma. In Canada, this trial would affect 20% of all patients with melanoma or 1400 patients per year. With the current lack of randomized data, international guidelines suggest WLE margins of 1-3cm around a stage II melanoma. Such surgery results in a defect of 3cm to 8cm (a result of a 1-3cm margin on either side of the melanoma which itself can be 1-2cm). In certain parts of the body where the skin is tight or there is less excess skin (e.g. mid-lower forearm, upper back or lower leg), this defect may need more extensive surgery such as a skin graft/skin flap to close the skin. Wider margins can increase morbidity, hospitalization rates, and recovery time and delay adjuvant systemic therapy. Patient groups emphasized the importance of minimizing disfigurement with surgery, wound discomfort, and time away from work, which may occur with narrower margins of excision. Research Aims Primary objective: To establish if there is non-inferiority disease-free survival (DFS) between patients managed with 1cm vs 2cm WLE for clinical stage II melanoma. Secondary objectives: To evaluate the impact of 1cm vs 2cm WLE on: 1) Distant DFS (DDFS), overall survival (OS), local recurrence (LR), and adverse events; 2) Patient health-related quality of life (QOL) using the FACT-M, PainDETECT questionnaires & EQ-5D-5L. Congratulations to the grant applicants Nominated Principal Applicant = Janet Dancey Principal Applicant = Frances Wright Co-Applicants: Chris Baliski Margot Burnell Bingshu Chen Alexandra Easson Valerie Francescutti Gary Groot Christopher Lee Carolyn Nessim Teresa Petrella Justin Rivard Heather Stuart Collaborators: Cindy Boulanger-Gobeil Jay Engel Mai-Kim Gervais Renee Hanrahan Steven Latosinsky Greg McKinnon David McMullen Sara Temple
