Reolysin in Combination With FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Metastatic Colorectal Cancer
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| ClinicalTrials.gov Identifier: NCT01622543 |
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Recruitment Status :
Completed
First Posted : June 19, 2012
Results First Posted : December 13, 2019
Last Update Posted : August 23, 2023
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Sponsor:
Canadian Cancer Trials Group
Collaborator:
Oncolytics Biotech
Information provided by (Responsible Party):
Canadian Cancer Trials Group
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Colorectal Cancer |
| Interventions |
Drug: Folfox plus Bevacizumab and reolysin Drug: Folfox plus Bevacizumab |
| Enrollment | 109 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | 6 patients were enrolled in a safety run-in phase of the study before randomized component was started. These 6 patients were not included in the final analysis. |
| Arm/Group Title | Folfox Plus Bevacizumab and Reolysin | Folfox Plus Bevacizumab |
|---|---|---|
 Arm/Group Description |
Folfox plus Bevacizumab and reolysin: FOLFOX6/bevacizumab infusion on day 1 of a 14 day cycle (IV bevacizumab 5mg/kg over 1 hour, oxaliplatin 85mg/m^2 and leucovorin 400 mg/m^2 concurrently over 2 hours, bolus fluorouracil 400 mg/m^2 after leucovorin, and continuous infusion of fluorouracil 2400 mg/m^2 over 46 hours) and reolysin 3x10^10 TCID_50 over 1 hour on days 1-5 of cycle 2, 4, 6, 8 and alternate cycles thereafter. | Folfox plus Bevacizumab: FOLFOX6/bevacizumab infusion on day 1 of a 14 day cycle (IV bevacizumab 5mg/kg over 1 hour, oxaliplatin 85mg/m^2 and leucovorin 400 mg/m^2 concurrently over 2 hours, bolus fluorouracil 400 mg/m^2 after leucovorin, and continuous infusion of fluorouracil 2400 mg/m^2 over 46 hours). |
| Period Title: Overall Study | ||
| Started | 51 | 52 |
| Completed | 51 | 52 |
| Not Completed | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Folfox Plus Bevacizumab and Reolysin | Folfox Plus Bevacizumab | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Folfox plus Bevacizumab and reolysin: FOLFOX6/bevacizumab given every 14 days plus reolysin days 1-5 on cycles 1, 2, 4, 6, 8 and alternate cycles thereafter | Folfox plus Bevacizumab: FOLFOX6/bevacizumab given every 14 days. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 51 | 52 | 103 | |
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Baseline Analysis Population Description |
All patients randomized to this study
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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| Number Analyzed | 51 participants | 52 participants | 103 participants | |
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60
(34 to 79)
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59
(31 to 78)
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60
(31 to 79)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 51 participants | 52 participants | 103 participants | |
| Female |
19 37.3%
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21 40.4%
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40 38.8%
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| Male |
32 62.7%
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31 59.6%
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63 61.2%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 51 participants | 52 participants | 103 participants | |
| Hispanic or Latino |
0 0.0%
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1 1.9%
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1 1.0%
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| Not Hispanic or Latino |
51 100.0%
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51 98.1%
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102 99.0%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| Canada | Number Analyzed | 51 participants | 52 participants | 103 participants |
| 51 | 52 | 103 | ||
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ECOG Performance Status
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 51 participants | 52 participants | 103 participants | |
| 0 |
20 39.2%
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27 51.9%
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47 45.6%
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| 1 |
29 56.9%
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23 44.2%
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52 50.5%
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| 2 |
2 3.9%
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2 3.8%
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4 3.9%
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[1]
Measure Description:
0: Fully active, able to carry on all pre-disease performance without restriction
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Dr. Derek Jonker |
| Organization: | The Ottawa Hospital - Cancer Centre |
| Phone: | 613-737-7700 ext 70170 |
| EMail: | djonker@ottawahospital.on.ca |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Canadian Cancer Trials Group |
| ClinicalTrials.gov Identifier: | NCT01622543 |
| Other Study ID Numbers: |
I210 |
| First Submitted: | June 12, 2012 |
| First Posted: | June 19, 2012 |
| Results First Submitted: | June 26, 2019 |
| Results First Posted: | December 13, 2019 |
| Last Update Posted: | August 23, 2023 |