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

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ClinicalTrials.gov Identifier: NCT04472910
Recruitment Status : Recruiting
First Posted : July 16, 2020
Last Update Posted : April 22, 2021
Sponsor:
Collaborator:
Pancreatic Cancer Canada
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Resectable Pancreatic Cancer Drug: Modified Folforinox (mFFX) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: GATA6 Expression as a Predictor of Response to Peri-Operative Chemotherapy in Resectable Pancreatic Adenocarcinoma: A Multicentre Canadian Phase II Study
Actual Study Start Date : August 21, 2020
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Neo-adjuvant mFFX
Neo-adjuvant mFFX up to 6 cycles, surgery, adjuvant chemotherapy for up tp 6 cycles, follow up
Drug: Modified Folforinox (mFFX)
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
Other Name: Folfirinox or other approach




Primary Outcome Measures :
  1. 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 ]
    Disease free survival


Secondary Outcome Measures :
  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. [ Time Frame: 2-4 years ]
  2. Determine GATA6 in-situ hybridization (ISH)/immunohistochemistry (IHC) success rate [ Time Frame: 2-4 years ]
  3. Determine GATA6 expression levels in EUS-FNB specimen compared to surgical specimen [ Time Frame: 2-4 years ]
  4. Determine the DFS according to R0 or R1 resection status [ Time Frame: 2-4 years ]
  5. Determine the DFS according to baseline Ca19.9 levels [ Time Frame: 2-4 years ]
  6. Determine the DFS according to modified Moffitt RNA classification [ Time Frame: 2-4 years ]
  7. To determine the overall response rate (ORR) to neoadjuvant mFFX [ Time Frame: 2-4 years ]
  8. Determine the percentage of patients who progress on neoadjuvant mFFX [ Time Frame: 2-4 years ]
  9. Assess pathological response rate to mFFX in the neoadjuvant setting [ Time Frame: 2-4 years ]
  10. 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 ]
  11. 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 ]
  12. 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 ]
  13. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
    • 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)

Exclusion Criteria:

  • 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.
  • History of Gilberts condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04472910


Contacts
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Contact: Anna Dodd 647-539-6498 anna.dodd@uhn.ca
Contact: Roxana Bucur 437-772-4354 roxana.bucur@uhn.ca

Locations
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Canada, British Columbia
BC Cancer Agency Vancouver Recruiting
Vancouver, British Columbia, Canada
Contact: Suilee Quach    604-877-6000 ext 674826      
Canada, Ontario
Kingston Health Sciences Centre Recruiting
Kingston, Ontario, Canada
Contact: Jackie Edwards    613-549-6666 ext 6820      
London Health Sciences Centre Recruiting
London, Ontario, Canada
Contact: Danielle Porplycia    519-685-8500 ext 54514      
Ottawa Hospital Not yet recruiting
Ottawa, Ontario, Canada
Contact: Rose Leclerc    613-737-7700      
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2N9
Contact: Anna Dodd    647-539-6498    anna.dodd@uhn.ca   
Sunnybrook Hospital/Odette Cancer Centre Recruiting
Toronto, Ontario, Canada
Contact: Roshni Ravindranathan    416-480-5000 ext 67336      
Unity Health (St. Joseph's and St. Michael's) Not yet recruiting
Toronto, Ontario, Canada
Contact: Kate Besel    416-864-6060 ext 2606      
Canada, Quebec
Jewish General Hospital Not yet recruiting
Montréal, Quebec, Canada
Contact: Gelareh Arzani    514-340-8222 ext 26755      
Sponsors and Collaborators
University Health Network, Toronto
Pancreatic Cancer Canada
Investigators
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Principal Investigator: Jennifer Knox, MD Princess Margaret Cancer Centre, University Health Network
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04472910    
Other Study ID Numbers: 19-6059
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: April 22, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Folfirinox
Antineoplastic Agents