To date, there have been no Canadian led neoadjuvant or peri-operative trials, this multicentre design gives the opportunity to build more experience with this strategy across Canada in more institutions. The design of this prospective trial will also test our important hypotheses regarding the use of biomarkers to understand the benefit of mFFX in improving outcomes for patients with resectable pancreas cancer. Data from this study would likely inform future studies where patients are given personalised options for the best treatment strategies rather than one empiric approach.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Neo-adjuvant mFFX for up to 6 cycles, chemo-Adjuvant FFX q 2 weekly or other approach as per investigator to complete up to 6 months chemotherapy
BC Cancer Agency Vancouver
Vancouver, British Columbia, Canada
Kingston Health Sciences Centre
Kingston, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Sunnybrook Hospital/Odette Cancer Centre
Toronto, Ontario, Canada
Unity Health (St. Joseph's and St. Michael's)
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
To assess disease free survival (DFS) in resectable PDAC treated with peri-operative mFFX according to baseline GATA6 expression level
Disease free survival
Time frame: 2-4 years
Evaluate the feasibility of EUS FNB as an effective modality for the detection of GATA6 expression at first diagnosis, including number of unsuccessful EUS-FNBs.
Time frame: 2-4 years
Determine GATA6 in-situ hybridization (ISH)/immunohistochemistry (IHC) success rate
Time frame: 2-4 years
Determine GATA6 expression levels in EUS-FNB specimen compared to surgical specimen
Time frame: 2-4 years
Determine the DFS according to R0 or R1 resection status
Time frame: 2-4 years
Determine the DFS according to baseline Ca19.9 levels
Time frame: 2-4 years
Determine the DFS according to modified Moffitt RNA classification
Time frame: 2-4 years
To determine the overall response rate (ORR) to neoadjuvant mFFX
Time frame: 2-4 years
Determine the percentage of patients who progress on neoadjuvant mFFX
Time frame: 2-4 years
Assess pathological response rate to mFFX in the neoadjuvant setting
Time frame: 2-4 years
Determine the overall survival (OS) according to GATA6 expression level in the overall population and the GATA6 high/low populations
Time frame: 2-4 years
Determine the overall survival (OS) according to R0/R1 resection status in the overall population and the GATA6 high/low populations
Time frame: 2-4 years
Determine the overall survival (OS) according to baseline Ca19.9 levels in the overall population and the GATA6 high/low populations
Time frame: 2-4 years
Determine the overall survival (OS) according modified Moffitt classification in the overall population and the GATA6 high/low populations
Time frame: 2-4 years
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