Primary Objective: To demonstrate that the addition of oxaliplatin to 5-Fluorouracil (5-FU) and Leucovorin (LV) will improve the Progression-Free Survival (PFS). Progression is based on RECIST (Response Evaluation Criteria In Solid Tumors) criteria or death Secondary Objective: To evaluate other measures of tumor responses, safety, quality of life (QoL), and health utility assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Pharmaceutical form:vials of 50 mg/5 mL or 500 mg/50mL Route of administration: IV Dose regimen:
Pharmaceutical form: Lyophilized powder for injection (50 mg/vial or 100 mg/vial) or aqueous solution (50 mg/10 mL and 100 mg/20 mL) Route of administration: IV Dose regimen:
Pharmaceutical form: vials of 5 g/100mL Route of administration: IV Dose regimen:
Investigational Site Number 124015
Abbotsford, Canada
Investigational Site Number 124018
Brampton, Canada
Investigational Site Number 124014
Burnaby, Canada
Progression-Free Survival (PFS)
PFS is defined as the time from the start of treatment to the date of disease progression or death from any cause.
Time frame: Within the 3 months of study treatment
Overall response rate (ORR)
ORR is based on RECIST criteria and is the percentage of patients with complete response (CR) or partial response (PR).
Time frame: 12 weeks
Duration of response
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence, i.e. progressive disease (PD) is determined by RECIST criteria or death
Time frame: 12 weeks
Disease Controlled Rate (DCR)
DCR is also based on RECIST criteria and is defined as the percentage of patients who have a CR, PR or stable disease (SD)
Time frame: 12 weeks
Median Overall Survival (OS)
Median Survival is the number of weeks at which 50% of the patients are still alive.
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigational Site Number 124006
Calgary, Canada
Investigational Site Number 124008
Greater Sudbury, Canada
Investigational Site Number 124011
Greenfield Park, Canada
Investigational Site Number 124010
Hamilton, Canada
Investigational Site Number 124-016
New Glasgow, Canada
Investigational Site Number 124013
Oshawa, Canada
Investigational Site Number 124012
Ottawa, Canada
...and 5 more locations