Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer

What is the Purpose of this Study?

The purpose of this study is to compare the usual treatment approach (surgery followed by chemotherapy) to using chemotherapy followed by surgery and then more chemotherapy in people with removable pancreatic cancer. The addition of chemotherapy before surgery to the usual treatment approach may extend life, but it could also cause side effects. Researchers will evaluate whether the study approach extends the life of patients compared to the usual approach. The chemotherapy drug regimen, FOLFIRINOX (leucovorin, 5-fluorouracil, irinotecan, and oxaliplatin), is already approved by the U.S. Food and Drug Administration (FDA) for use in pancreatic cancer; however, it is generally not used until after surgery. Participants will be randomly assigned to receive either the study drugs FOLFIRINOX for about 4 months followed by surgery and then more FOLFIRINOX for about 2 months (Group 1), or surgery followed by FOLFIRINOX for about 6 months (Group 2).

Eligibility

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)

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

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Where can I participate?

Cedars-Sinai Cancer at Beverly Hills (THO)
Cedars-Sinai Cancer at SOCC

More about this Clinical Trial

What is the full name of this clinical trial?

A021806: A Phase III Trial of Perioperative versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer

Study Details

Disease Type/Condition

Pancreatic Cancer

Principal Investigator

Osipov, Arsen

Co-Investigators

Andrew Hendifar, David Hoffman, Jeremy Lorber, Jun Gong, Kevin Scher

Age Group

Adult

Phase

III (Cancer Control)

IRB Number

STUDY00001039

ClinicalTrials.gov ID

NCT04340141

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org