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

NCT04472910 | Active Not Recruiting DMC

• 1 other identifier: 19-6059
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Resectable Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

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

  Disease free survival

  2-4 years

Secondary Outcomes (13)

• 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.

  2-4 years

• Determine GATA6 in-situ hybridization (ISH)/immunohistochemistry (IHC) success rate

  2-4 years

• Determine GATA6 expression levels in EUS-FNB specimen compared to surgical specimen

  2-4 years

• Determine the DFS according to R0 or R1 resection status

  2-4 years

• Determine the DFS according to baseline Ca19.9 levels

  2-4 years

Study Arms (1)

Neo-adjuvant mFFX

EXPERIMENTAL

Neo-adjuvant mFFX up to 6 cycles, surgery, adjuvant chemotherapy for up tp 6 cycles, follow up

Drug: Modified Folforinox (mFFX)

Interventions

Modified Folforinox (mFFX) DRUG

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

Also known as: Folfirinox or other approach

Neo-adjuvant mFFX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a histological diagnosis of PDAC. Those with unconfirmed histology must have this confirmed by EUS-FNB in the pre-screening period prior to commencement of chemotherapy. Invasive PDAC in the setting of intraductal papillary mucinous neoplasm (IPMN) is permitted.
• Patients must consent to EUS-FNB for correlative analysis even if adenocarcinoma has been confirmed, unless confirmation was performed using a previous biopsy or fine needle biopsy with adequate tumour tissue for GATA6 analysis.
• Resectable primary tumour on preoperative biphasic (arterial and venous phases) contrast-enhanced CT for pancreatic staging as per institutional standard of care, with ≤5 mm slice thickness. MRI for liver metastases (optional) as per institutional standard of care. The definition of resectability (as per NCCN guidelines - see Appendix B) includes:
• no involvement of the celiac artery, common hepatic artery or superior mesenteric artery (or if present a replaced right or common hepatic artery)
• no involvement or \<180 (interface between tumour and vessel wall, of the portal vein or superior mesenteric vein, and patent portal vein/splenic vein confluence\_
• For tumours of the body and tail of the pancreas, involvement of the splenic artery and vein of any degree is considered resectable disease
• Patients must be medically fit to undergo surgical resection
• No prior oncological treatment for index PDAC
• ECOG Performance status 0-1
• Age \> 18 years
• Patients must be medically suitable for treatment with mFFX as per treating medical oncologist
• No evidence of metastases (i.e., metastatic work-up negative including a CT scan of the chest, abdomen (IV and oral contrast, 3 phase) and pelvis)
• Adequate hematologic function
• absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
• platelets ≥ 100 000 cells/mm3

You may not qualify if:

• Patients where attempted EUS-FNB x 2 has not confirmed PDAC in the setting of unconfirmed histology.
• Patients in whom histology has confirmed PDAC but who do not consent to EUS-FNB, unless previous confirmation was by biopsy or fine needle biopsy with adequate tumour tissue for GATA6 analysis.
• Non-ductal pancreas tumours including endocrine tumours, acinar cell carcinoma, cyst adenocarcinoma or ampullary tumours.
• Unresectable PDAC by contrast enhanced CT or MRI. Borderline resectable PDAC (vein and artery) are excluded from this study
• Evidence of metastatic disease
• Prior treatment for index PDAC
• Previous autologous bone marrow transplant or stem cell rescue
• Active hepatitis B or C infection
• Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
• History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early stage prostate cancer or curatively treated cervical carcinoma in situ or other indolent malignancy (discretion of PI).
• Pregnant or breast-feeding patients are excluded from this study as the chemotherapy agents used in this study have been demonstrated or have the potential to be teratogenic and there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother
• Patients who are being therapeutically anticoagulated with coumadin and cannot have an alternative anticoagulation regimen.
• Known hypersensitivity to any of the drugs used or their components.
• Patients with known complete absence of dihydropyrimidine dehydrogenase (DPD) activity.
• History of QT prolongation or receiving QT prolonging medications.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Pancreatic Cancer Canada: collaborator

Study Sites (8)

BC Cancer Agency Vancouver

Vancouver, British Columbia, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

Ottawa Hospital

Ottawa, Ontario, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2N9, Canada

Location

Sunnybrook Hospital/Odette Cancer Centre

Toronto, Ontario, Canada

Location

Unity Health (St. Joseph's and St. Michael's)

Toronto, Ontario, Canada

Location

Jewish General Hospital

Montreal, Quebec, Canada

Location

MeSH Terms

Interventions

folfirinox

Study Officials

• Jennifer Knox, MD

  Princess Margaret Cancer Centre, University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: July 16, 2020
• Study Start: August 21, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8)