Wednesday, September 26, 2018 IND.210 A Randomized Phase II Study of Reolysin in Combination with FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Al one in Patients with Metastatic Colorectal Cancer To evaluate the effect of reolysin in combination with standard FOLFOX6 chemotherapy of the progression free survival of patients with advanced or metastatic colorectal cancer. To determine the tolerability and toxicity of reolysin and FOLFOX6/Bevacizumab when given in combination. To investigate additional potential measures of efficacy including:change in CEA levels; objective response rate; evaluate the effect of both treatments on overall survival (OS) To explore potential molecular factors that may be prognostic or predictive of response by assessment of archival tumour tissue and serial blood samples To explore the Quality of Life (as measured by the EORTC QLQC30) IND.210 has been permanently closed. No further ethics approvals or folow up data are required. The notification of permanent trial closure is posted on the CCTG website: https://www.ctg.queensu.ca/docs/trials/permanent_closure/I210-CTG-led-Final%20Letter_to_Cdn_sites.pdf The primary publication Mar 2018: Jonker DJ, Tang PA, Kennecke H, Welch SA, Cripps MC, Asmis T, Chalchal H, Tomiak A, Lim H, Ko YJ, Chen EX, Alcindor T, Goffin JR, Korpanty GJ, Feilotter H, Tsao MS, Theis A, Tu D, Seymour L A Randomized Phase Two Study of FOLFOX6/bevacizumab with or without pelareorep in Patients with Metastatic Colorectal Cancer: IND.210, a Canadian Cancer Trials Group Trial Clinical Colorectal Cancer: ONLINE, 2018
