Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer
Launched by ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY · Apr 7, 2020
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how effective chemotherapy is when given both before and after surgery for patients with removable pancreatic cancer, compared to giving chemotherapy only after surgery. The chemotherapy drugs used in this trial help stop cancer cells from growing and spreading, which may lead to better outcomes for patients. Researchers want to find out if starting chemotherapy before surgery can improve treatment results for those diagnosed with pancreatic adenocarcinoma or adenosquamous carcinoma.
To participate in the trial, patients must have a specific type of pancreatic cancer that can be surgically removed, confirmed by imaging tests. They should not have received previous treatment for pancreatic cancer and must meet certain health criteria, such as having a good performance status and normal blood counts. Participants can expect to receive chemotherapy treatment before and after their surgery and will be closely monitored throughout the trial. It's important to note that pregnant or nursing women cannot join the study, and participants must have a negative pregnancy test before starting. This trial is currently looking for volunteers to help advance our understanding of the best ways to treat pancreatic cancer.
Gender
ALL
Eligibility criteria
- 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
About Alliance For Clinical Trials In Oncology
The Alliance for Clinical Trials in Oncology is a prominent cooperative group dedicated to conducting high-quality, innovative clinical research aimed at improving cancer treatment and patient outcomes. Comprising a diverse network of institutions and investigators, the Alliance focuses on developing and implementing clinical trials that evaluate new therapies, treatment combinations, and prevention strategies across various cancer types. By fostering collaboration among oncologists, researchers, and healthcare professionals, the Alliance aims to accelerate the translation of scientific discoveries into effective clinical practices, ultimately enhancing the standard of care for cancer patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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Jefferson City, Missouri, United States
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Ridgewood, New Jersey, United States
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East Hills, New York, United States
Irvine, California, United States
Troy, Michigan, United States
Mitchell, South Dakota, United States
Saginaw, Michigan, United States
West Harrison, New York, United States
Southfield, Michigan, United States
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Detroit, Michigan, United States
Warren, Michigan, United States
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Mount Vernon, Illinois, United States
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Denver, Colorado, United States
Rolla, Missouri, United States
Raleigh, North Carolina, United States
Cape Girardeau, Missouri, United States
Patients applied
Trial Officials
Cristina R. Ferrone, MD
Study Chair
Massachusetts General Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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