The purpose of this study is to find out if giving reolysin in combination with FOLFOX6/ bevacizumab can offer better results than standard therapy with FOLFOX6/ bevacizumab.
Researchers doing this study also want to evaluate the side effects of reolysin when given together with FOLFOX6/ bevacizumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
109
FOLFOX6/bevacizumab given every 14 days plus reolysin days 1-5 on cycles 1, 2, 4, 6, 8 and alternate cycles thereafter
FOLFOX6/bevacizumab given every 14 days.
Tom Baker Cancer Centre
Calgary, Alberta, Canada
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
Progression Free Survival
Time from the day of randomization until the first observation of objective disease relapse or progression, or the appearance of new lesions or death due to any cause. If a patient had not relapsed/progressed or died, PFS was censored on the date of last disease assessment defined as the earliest test date of target lesion or non-target lesions (if patient had no target lesions). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: 19 months
Changes in CEA Levels
Changes in CEA level from baseline to week 28 during treatment.
Time frame: Baseline and at 28 weeks
Objective Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate =Proportion of (CR + PR) observed over all randomized patients.
Time frame: 19 months
Overall Survival
Time from randomization to death from any cause or censored at the time of last known alive
Time frame: From date of randomization to death from any cause or censored at the time of last known alive, assessed up to 49 months
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Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, Canada
London Regional Cancer Program
London, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Odette Cancer Centre
Toronto, Ontario, Canada
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada
McGill University - Dept. Oncology
Montreal, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada