IRB Study Number 21-240
Status Recruiting
Phase Phase 3
Location Akron General
Institute Taussig Cancer Institute
Description
Primary Objective
To evaluate and compare overall survival (OS) in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX
Secondary Objectives
1 To evaluate and compare disease-free survival (DFS) in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX
2 To evaluate and compare time to locoregional recurrence (TLR) in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX
3 To evaluate and compare time to distant metastases (TDM) in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX
4 To evaluate and compare the R0 resection rate in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX
5 To evaluate and compare rate of unresectability in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX
6 To evaluate rate of pathologic complete response in patients randomized to the perioperative therapy arm
7 To evaluate and compare mFOLFIRINOX dose intensity delivered and number of cycles received in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX
8 To evaluate and compare adverse event profile in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX
9 To compare physical functioning, nausea/vomiting, and diarrhea, as measured with the EORTC QLQ-C30 between patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX
10 To prospectively assess the influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on the disease-free survival and overall survival among patients with localized pancreatic cancers
11 To assess the influence of diet, obesity, physical activity, and other lifestyle habits on the risk of toxicity associated with chemotherapy
12 To evaluate the ability of CT-based radiomics in distinguishing post-neoadjuvant chemotherapy (NAC) fibrosis from viable tumor in patients randomized to the perioperative therapy arm
13 To determine whether CT-based radiomics retrieved from baseline examination may act as non-invasive predictors of survival outcome in patients randomized to the adjuvant therapy arm
Inclusion Criteria
1 Documentation of Disease
Pathology: Histologic or cytologic proof of pancreatic adenocarcinoma or adenosquamous carcinoma.
TNM Stage: Tx-4, N0-1, M0; M0 disease does not include spread to distant lymph nodes and organs
Resectable Primary Tumor: Local radiographic reading must be consistent with resectable disease defined as the following on 1) arterial and venous phase contrast-enhanced abdominal/pelvic CT scan or abdominal/pelvic MRI scan and 2) chest CT:
• No involvement or abutment of the celiac artery, common hepatic artery, superior mesenteric artery, or replaced right hepatic artery (if applicable)
• Less than 180° interface between tumor and vessel wall of the portal vein or superior mesenteric vein, and patent portal vein/splenic vein confluence
• No evidence of metastatic disease
2 Measurable disease or non-measurable disease as defined in Section 11.0.
Non-measurable disease is defined as cytologic or histologic confirmation of adenocarcinoma of adenosquamous carcinoma by fine needle aspiration or core-biopsy of the pancreas without measurable disease by radiographic imaging.
1 Disease Status: Confirmation of resectable disease by real-time central imaging review by the Alliance Imaging Core Lab at IROC Ohio. Determined to be appropriate candidate for curative-intent pancreatectomy by surgeon intending to perform the resection.
2 Prior Treatment: No prior radiation therapy, chemotherapy, targeted therapy, investigational therapy, or surgery for pancreatic cancer.
3 Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 14 days prior to registration is required.
4 Age ≥ 18 years
5 ECOG Performance Status 0-1
6 Total Neuropathy Score < 2
7 Required Initial Laboratory Values
• Absolute Neutrophil Count (ANC) ≥ 1,500/μL
• Platelet Count ≥ 100,000/μL
• Total Bilirubin ≤ 1.5 x upper limit of normal (ULN)
• Creatinine ≤ 1.5 x ULN or Calc. Creatinine Clearance ≥ 30 mL/min
8 Comorbid Conditions: No known Gilbert’s Syndrome or known homozygosity for UGAT1A1 28 polymorphism. No comorbid conditions that would prohibit curative-intent pancreatectomy.
9 Concomitant Medications: Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug prior to registration. See Section 8.1.11 for more information. Chronic concomitant treatment with strong inducers of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inducers must discontinue the drug prior to registration. See Section 8.1.12 for more information.
Exclusion Criteria
none
