Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer

Description

This phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly).

Conditions

Pancreatic Adenosquamous Carcinoma, Resectable Pancreatic Adenocarcinoma, Pancreatic Cancer

Study Overview

Study Details

Study overview

This phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly).

A Phase III Trial of Perioperative Versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer

Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer

Condition
Pancreatic Adenosquamous Carcinoma
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States, 35233

Fairhope

Thomas Hospital, Fairhope, Alabama, United States, 36532

Mobile

Mobile Infirmary Medical Center, Mobile, Alabama, United States, 36607

Mobile

University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, United States, 36688

Anchorage

Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States, 98508

Anchorage

Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States, 99508

Anchorage

Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States, 99508

Anchorage

Alaska Women's Cancer Care, Anchorage, Alaska, United States, 99508

Anchorage

Anchorage Oncology Centre, Anchorage, Alaska, United States, 99508

Anchorage

Katmai Oncology Group, Anchorage, Alaska, United States, 99508

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alliance for Clinical Trials in Oncology,

Cristina R. Ferrone, MD, STUDY_CHAIR, Massachusetts General Hospital

Study Record Dates

2030-11