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Using chemotherapy before and after surgery for removable pancreatic cancer

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

Phase 3 Interventional Alliance for Clinical Trials in Oncology · NCT04340141

This study tests whether giving chemotherapy before and after surgery can help people with removable pancreatic cancer live longer and have fewer recurrences compared to just giving it after surgery.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment352 (estimated)
Ages18 Years and up
SexAll
SponsorAlliance for Clinical Trials in Oncology Academic / other
Drugs / interventionschemotherapy, Radiation
Locations450 sites (Birmingham, Alabama and 449 other locations)
Trial IDNCT04340141 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with resectable pancreatic adenocarcinoma or adenosquamous carcinoma who meet specific staging criteria.

Not a fit: Patients with metastatic pancreatic cancer or those whose tumors are deemed unresectable will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved survival rates and better management of pancreatic cancer for patients.

How similar studies have performed: Other studies have shown promising results with similar perioperative chemotherapy approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 449 other locations

+400 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pancreatic Adenosquamous CarcinomaResectable Pancreatic AdenocarcinomaPancreatic Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.