- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04472910
GATA6 Expression as a Predictor of Response to Peri-Operative Chemotherapy in Resectable Pancreatic Adenocarcinoma (NeoPancOne)
November 24, 2023 updated by: University Health Network, Toronto
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Anna Dodd
- Phone Number: 647-539-6498
- Email: anna.dodd@uhn.ca
Study Contact Backup
- Name: Roxana Bucur
- Phone Number: 437-772-4354
- Email: roxana.bucur@uhn.ca
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada
- BC Cancer Agency Vancouver
-
-
Ontario
-
Kingston, Ontario, Canada
- Kingston Health Sciences Centre
-
London, Ontario, Canada
- London Health Sciences Centre
-
Ottawa, Ontario, Canada
- Ottawa Hospital
-
Toronto, Ontario, Canada, M5G 2N9
- Princess Margaret Cancer Centre
-
Toronto, Ontario, Canada
- Sunnybrook Hospital/Odette Cancer Centre
-
Toronto, Ontario, Canada
- Unity Health (St. Joseph's and St. Michael's)
-
-
Quebec
-
Montréal, Quebec, Canada
- Jewish General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Neo-adjuvant mFFX
Neo-adjuvant mFFX up to 6 cycles, surgery, adjuvant chemotherapy for up tp 6 cycles, follow up
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2-4 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
2-4 years
|
Determine GATA6 in-situ hybridization (ISH)/immunohistochemistry (IHC) success rate
Time Frame: 2-4 years
|
2-4 years
|
Determine GATA6 expression levels in EUS-FNB specimen compared to surgical specimen
Time Frame: 2-4 years
|
2-4 years
|
Determine the DFS according to R0 or R1 resection status
Time Frame: 2-4 years
|
2-4 years
|
Determine the DFS according to baseline Ca19.9 levels
Time Frame: 2-4 years
|
2-4 years
|
Determine the DFS according to modified Moffitt RNA classification
Time Frame: 2-4 years
|
2-4 years
|
To determine the overall response rate (ORR) to neoadjuvant mFFX
Time Frame: 2-4 years
|
2-4 years
|
Determine the percentage of patients who progress on neoadjuvant mFFX
Time Frame: 2-4 years
|
2-4 years
|
Assess pathological response rate to mFFX in the neoadjuvant setting
Time Frame: 2-4 years
|
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
|
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
|
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
|
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
|
2-4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jennifer Knox, MD, Princess Margaret Cancer Centre, University Health Network
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 21, 2020
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
June 23, 2020
First Submitted That Met QC Criteria
July 14, 2020
First Posted (Actual)
July 16, 2020
Study Record Updates
Last Update Posted (Actual)
November 27, 2023
Last Update Submitted That Met QC Criteria
November 24, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-6059
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Resectable Pancreatic Cancer
-
UNC Lineberger Comprehensive Cancer CenterRecruitingPancreatic Neoplasms | Pancreas Adenocarcinoma | Pancreatic Cancer Resectable | Cancer of Pancreas | Pancreatic Cancer Non-resectable | Pancreatic Ductal Adenocarcinoma (PDAC) | Pancreatic Cancer, AdultUnited States
-
National Cancer Institute (NCI)RecruitingPancreatic Acinar Cell Carcinoma | Pancreatic Adenosquamous Carcinoma | Pancreatic Squamous Cell Carcinoma | Resectable Pancreatic Acinar Cell Carcinoma | Resectable Pancreatic Adenocarcinoma | Resectable Pancreatic Adenosquamous Carcinoma | Resectable Pancreatic CarcinomaUnited States
-
Kimberly Perez, MDNovartisTerminatedPancreatic Cancer | Pancreatic Adenocarcinoma | Resectable Pancreatic Cancer | Borderline Resectable Pancreatic AdenocarcinomaUnited States
-
Memorial Sloan Kettering Cancer CenterRecruitingPancreatic Cancer | Pancreatic Cancer Metastatic | Pancreatic Cancer Stage IV | Metastatic Pancreatic Carcinoma | Metastatic Pancreatic Adenocarcinoma | Pancreatic Carcinoma | Metastatic Pancreatic Cancer | Pancreatic Cancer Non-resectable | Metastatic Pancreatic Ductal Adenocarcinoma | Pancreatic Carcinoma... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingBorderline Resectable Pancreatic Adenocarcinoma | Resectable Pancreatic Ductal Adenocarcinoma | Locally Advanced Pancreatic Ductal AdenocarcinomaUnited States
-
Gangnam Severance HospitalCompletedResectable Pancreatic AdenocarcinomaKorea, Republic of
-
M.D. Anderson Cancer CenterRecruitingBorderline Resectable Pancreatic Adenocarcinoma | Stage IA Pancreatic Cancer AJCC v8 | Stage IB Pancreatic Cancer AJCC v8 | Stage IIA Pancreatic Cancer AJCC v8 | Stage IIB Pancreatic Cancer AJCC v8 | Resectable Pancreatic AdenocarcinomaUnited States
-
Wakayama Medical UniversityRecruitingResectable Pancreatic Body/Tail CarcinomaJapan
-
Lawson Health Research InstituteLondon Health Sciences FoundationNot yet recruitingBorderline Resectable Pancreatic Adenocarcinoma | Resectable Pancreatic Adenocarcinoma
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingStage III Pancreatic Cancer AJCC v8 | Borderline Resectable Pancreatic Adenocarcinoma | Resectable Pancreatic Ductal Adenocarcinoma | Locally Advanced Pancreatic Ductal AdenocarcinomaUnited States
Clinical Trials on Modified Folforinox (mFFX)
-
Centre Hospitalier Universitaire DijonRecruitingLocally Advanced or Metastatic Small Bowel AdenocarcinomaFrance
-
AbbVieActive, not recruitingPancreatic CancerUnited States, Australia, Israel, Korea, Republic of, Puerto Rico, Spain
-
Federation Francophone de Cancerologie DigestiveCompletedAdenocarcinoma of RectumFrance
-
Immuneering CorporationRecruitingPancreatic Adenocarcinoma | Advanced Solid Tumor | Non-small Cell Lung Cancer (NSCLC) | Malignant Melanoma (Cutaneous)United States
-
Wilfrid Laurier UniversityCompletedAccidental FallsCanada
-
Riphah International UniversityCompletedShoulder CapsulitisPakistan
-
King Saud UniversityCompletedStiffness of Shoulder, Not Elsewhere ClassifiedSaudi Arabia
-
Bulent Ecevit UniversityCompletedPeriodontal Diseases | Periodontitis, Aggressive | Diode Laser Therapy
-
Manhattan Physical Medicine and Rehabilitation,...Carnegie Mellon UniversityCompletedRotator Cuff InjuriesUnited States
-
Sun Pharma Advanced Research Company LimitedCompleted