GATA6 Expression as a Predictor of Response to Peri-Operative Chemotherapy in Resectable Pancreatic Adenocarcinoma

Official Title

GATA6 Expression as a Predictor of Response to Peri-Operative Chemotherapy in Resectable Pancreatic Adenocarcinoma: A Multicentre Canadian Phase II Study

Summary:

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.

Trial Description

Primary Outcome:

• To assess disease free survival (DFS) in resectable PDAC treated with peri-operative mFFX according to baseline GATA6 expression level

• 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.
• Determine GATA6 in-situ hybridization (ISH)/immunohistochemistry (IHC) success rate
• Determine GATA6 expression levels in EUS-FNB specimen compared to surgical specimen
• Determine the DFS according to R0 or R1 resection status
• Determine the DFS according to baseline Ca19.9 levels
• Determine the DFS according to modified Moffitt RNA classification
• To determine the overall response rate (ORR) to neoadjuvant mFFX
• Determine the percentage of patients who progress on neoadjuvant mFFX
• Assess pathological response rate to mFFX in the neoadjuvant setting
• Determine the overall survival (OS) according to GATA6 expression level in the overall population and the GATA6 high/low populations
• Determine the overall survival (OS) according to R0/R1 resection status in the overall population and the GATA6 high/low populations
• Determine the overall survival (OS) according to baseline Ca19.9 levels in the overall population and the GATA6 high/low populations
• Determine the overall survival (OS) according modified Moffitt classification in the overall population and the GATA6 high/low populations

View this trial on ClinicalTrials.gov