A Phase III Trial of Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer.
Primary Objective:
1. 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.
- Rutgers Cancer Institute of New Jersey
- RWJBarnabas Health
- Cooperman Barnabas, Livingston
- Principal Investigator
- Russell Langan MD
- Principal Investigator
- Jersey City Medical Center, Jersey City
- Monmouth Medical Center
- Monmouth Medical Center Southern Campus
- Cooperman Barnabas, Livingston
Inclusion Criteria
PRE-REGISTRATION:
- 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 magnetic resonance
imaging (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 degree 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
- Measurable disease or non-measurable disease o 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
REGISTRATION:
- Confirmation of resectable disease by real-time central imaging review by the Alliance
Imaging Core Lab at Imaging and Radiation Oncology Core (IROC) Ohio
- Determined to be appropriate candidate for curative-intent pancreatectomy by surgeon
intending to perform the resection
- No prior radiation therapy, chemotherapy, targeted therapy, investigational therapy,
or surgery for pancreatic cancer
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Total Neuropathy Score < 2
- Absolute neutrophil count (ANC) >= 1,500/uL
- Platelet count >= 100,000/uL
- Total bilirubin =< 1.5 x upper limit of normal (ULN) (If obstructive jaundice is
present, then biliary drainage must be initiated and total bilirubin =< 3.0)
- Creatinine =< 1.5 x ULN OR calculated (Calc.) creatinine clearance >= 30 mL/min
(Calculated using the Cockcroft-Gault equation)
- No known Gilbert's Syndrome or known homozygosity for UGAT1A1*28 polymorphism
- No comorbid conditions that would prohibit curative-intent pancreatectomy
- 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
- 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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.