Using chemotherapy before and after surgery for removable pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III trial compares the effectiveness of perioperative chemotherapy, administered before and after surgery, to adjuvant chemotherapy, which is given only after surgery, for patients with resectable pancreatic cancer. The chemotherapy regimen includes drugs like fluorouracil, irinotecan, leucovorin, and oxaliplatin, which target tumor cells in various ways. The primary goal is to evaluate overall survival rates, while secondary objectives include assessing disease-free survival, locoregional recurrence, distant metastases, and resection rates. This approach aims to determine if administering chemotherapy in a perioperative setting improves outcomes compared to the traditional adjuvant approach.

Why it matters

Who can join: the full rules

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

Where it's running

• Thomas Hospital
  Fairhope, Alabama, United States Recruiting
• Mobile Infirmary Medical Center
  Mobile, Alabama, United States Recruiting
• University of South Alabama Mitchell Cancer Institute
  Mobile, Alabama, United States Recruiting
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
  Jonesboro, Arkansas, United States Recruiting
• Kaiser Permanente-Anaheim
  Anaheim, California, United States Recruiting
• Kaiser Permanente-Deer Valley Medical Center
  Antioch, California, United States Recruiting

+400 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Cristina R. Ferrone, MD
• Email: cferrone@mgh.harvard.edu
• Phone: 617-643-6189

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Zoldonrasib plus Daraxonrasib vs Gemcitabine and Nab-Paclitaxel as first-line treatment for metastatic KRAS G12D pancreatic cancer

  This study tests whether two investigational RAS inhibitors together can improve outcomes compared with standard chemotherapy in adults with newly diagnosed metastatic pancreatic cancer carrying the KRAS G12D mutation.

  Recruiting at 6 sites Phase 3 Revolution Medicines, Inc. · Phoenix, Arizona and 5 other locations · NCT07805954

• Zoldonrasib + chemotherapy vs placebo + chemotherapy as first-line treatment for metastatic KRAS G12D pancreatic cancer

  This trial tests whether adding zoldonrasib to standard chemotherapy helps people with newly diagnosed metastatic KRAS G12D pancreatic cancer.

  Recruiting at 25 sites Phase 3 Revolution Medicines, Inc. · Phoenix, Arizona and 24 other locations · NCT07621718

• Daraxonrasib alone or with gemcitabine and nab-paclitaxel for first-line metastatic pancreatic cancer

  This trial will see if daraxonrasib, alone or with gemcitabine and nab-paclitaxel, helps people with newly diagnosed metastatic pancreatic cancer live longer or slow tumor growth compared with standard gemcitabine and nab-paclitaxel.

  Recruiting at 61 sites Phase 3 Revolution Medicines, Inc. · Phoenix, Arizona and 81 other locations · NCT07491445

• Evaluating the effects of oxaliplatin on liver and nerve toxicity in cancer patients

  This study is testing how the cancer drug oxaliplatin affects the liver and nerves in patients with pancreatic and esophageal cancers to help make chemotherapy safer and more effective.

  Recruiting University Hospital, Clermont-Ferrand · Clermont-Ferrand · NCT06649474

• Using Olaparib to Prevent Recurrence in Patients with Resected Pancreatic Cancer and Specific Genetic Mutations

  This study is testing if the drug olaparib can help prevent pancreatic cancer from coming back in patients who have had surgery and specific genetic mutations.

  Recruiting at 261 sites Phase 2 National Cancer Institute (NCI) · Anchorage, Alaska and 455 other locations · NCT04858334

• Dendritic cell therapy combined with chemotherapy for pancreatic cancer

  This study is testing a new treatment that combines a special type of immune cell therapy with chemotherapy to see if it helps people with pancreatic cancer after surgery.

  Recruiting at 3 sites Phase 1 Diakonos Oncology Corporation · Houston, Texas and 2 other locations · NCT04157127

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.