Wednesday, March 28, 2018 IND210: A Randomized Phase II Study of Reolysin in Combination with FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Patients with Metastatic Colorectal Cancer 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 (ONLINE). Clinical Colorectal Cancer 2018. https://www.sciencedirect.com/science/article/pii/S1533002817304620 About the trial Eligibility: Patients with a histological diagnosis of metastatic colorectal adenocarcinoma. Tumour block available. Patients must have measurable disease as defined by RECIST 1.1. No prior chemotherapy for metastatic disease. Prior adjuvant fluropyrimidine based therapy is permitted >= 12 months prior to enrollment. ECOG 0, 1 or 2. Adequate end-organ function. No neuropathy > grade1 Objectives: 1. 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. 2a. To determine the tolerability and toxicity of reolysin and FOLFOX6/Bevacizumab when given in combination. 2b. 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) 2c.To explore potential molecular factors that may be prognostic or predictive of response by assessment of archival tumour tissue and serial blood samples 2d.To explore the Quality of Life (as measured by the EORTC QLQC30)
