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Resectable Pancreatic CancerNeoPancOneNCT04472910

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

A study testing Modified Folforinox (mFFX) in people with Resectable Pancreatic Cancer, run by University Health Network, Toronto at 8 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Resectable Pancreatic Cancer
What is being tested?
Modified Folforinox (mFFX)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
8 sitesCanada
Study dates
21 Aug 2020to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • hemoglobin ≥ 9 g/L (after transfusion is acceptable))
  • Creatinine level < 130 µmol/L or CrCl ≥ 50 ml/min
  • Patients of child-bearing potential (for female patient: study entry after a menstrual period and a negative pregnancy test) must agree to use two medically acceptable methods of contraception (one for the patient and one for their partner) during the study and for 4 months after the last study treatment intake for women and 6 months for men. These patients must have a pregnancy test repeated every month while on chemotherapy.
  • Patients must be able to provide written informed consent
  • Adequate liver function (AST <2.5 times the institutional upper limit of normal at the baseline visit, total bilirubin ≤ 2 times the institutional upper limit of normal at the baseline visit)

Who cannot join

  • 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
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  • 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.
  • History of Gilberts condition

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Canada8 sites

  • Kingston Health Sciences Centre

    Kingston, Ontario

  • London Health Sciences Centre

    London, Ontario

  • Jewish General Hospital

    Montreal, Quebec

  • Ottawa Hospital

    Ottawa, Ontario

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2N9

  • Sunnybrook Hospital/Odette Cancer Centre

    Toronto, Ontario

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

    Toronto, Ontario

  • BC Cancer Agency Vancouver

    Vancouver, British Columbia

Other trials in Canada

About this study

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

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.

Being tested
Modified Folforinox (mFFX)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified Folforinox (mFFX)Drug

    Also called Folfirinox or other approach

    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

Study groups in NCT04472910
Study groupRoleWhat they receive
Neo-adjuvant mFFXExperimentalNeo-adjuvant mFFX up to 6 cycles, surgery, adjuvant chemotherapy for up tp 6 cycles, follow up
Receives: Drug: Modified Folforinox (mFFX)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Disease free survival

    Measured: 2-4 years

Secondary outcomes (13)

  1. 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.

    Measured: 2-4 years

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

    Measured: 2-4 years

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

    Measured: 2-4 years

  4. Determine the DFS according to R0 or R1 resection status

    Measured: 2-4 years

  5. Determine the DFS according to baseline Ca19.9 levels

    Measured: 2-4 years

  6. Determine the DFS according to modified Moffitt RNA classification

    Measured: 2-4 years

  7. To determine the overall response rate (ORR) to neoadjuvant mFFX

    Measured: 2-4 years

  8. Determine the percentage of patients who progress on neoadjuvant mFFX

    Measured: 2-4 years

  9. Assess pathological response rate to mFFX in the neoadjuvant setting

    Measured: 2-4 years

  10. Determine the overall survival (OS) according to GATA6 expression level in the overall population and the GATA6 high/low populations

    Measured: 2-4 years

  11. Determine the overall survival (OS) according to R0/R1 resection status in the overall population and the GATA6 high/low populations

    Measured: 2-4 years

  12. Determine the overall survival (OS) according to baseline Ca19.9 levels in the overall population and the GATA6 high/low populations

    Measured: 2-4 years

  13. Determine the overall survival (OS) according modified Moffitt classification in the overall population and the GATA6 high/low populations

    Measured: 2-4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2020
  2. Study start21 Aug 2020
  3. Primary completionJun 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04472910
Sponsor's protocol ID
19-6059
Acronym
NeoPancOne
Status last verified
Mar 2026
First submitted
23 Jun 2020
Last updated
12 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Modified Folforinox (mFFX) in people with Resectable Pancreatic Cancer, run by University Health Network, Toronto at 8 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess disease free survival (DFS) in resectable PDAC treated with peri-operative mFFX according to baseline GATA6 expression level (time frame: 2-4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04472910.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.

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