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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Pancreatic Cancer Adaptive Neoadjuvant Chemotherapy Trial

Adaptive Modification of Neoadjuvant Therapy Based on Clinical Response in Patients With Localized Pancreatic Cancer

Pancreatic Cancer Adaptive Neoadjuvant Chemotherapy Trial (NCT03322995) is a Phase 2 interventional studying Pancreatic Cancer, sponsored by Medical College of Wisconsin. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is an open-label, phase II study in patients with resectable and borderline resectable pancreas cancer.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Pancreatic Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 125 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Pancreatic Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

INCLUSION CRITERIA - Be 18 years of age or older. - Be able to understand and provide written willing to sign a consent form or have a legally authorized representative (LAR). - Have an Eastern Cooperative Group (ECOG) performance status \< 2 (please see the appendix). - Have documentation of diagnosed by tissue sample (biopsy-confirmed) adenocarcinoma. Biopsy must have been completed prior to start of treatment; additional biopsy is not required for the study. - Have clinical stage consistent with resectable or borderline resectable adenocarcinoma of the pancreas, based on CT or MRI findings. - Have adequate organ and bone marrow function, as defined by: - total leukocytes \>3 x10\^3/μL. - absolute neutrophil count (ANC) \>1.5x 10\^3/μL. - hemoglobin \>9 g/dL. - platelets \>100 x 10\^3/μL. - creatinine clearance \>60 mL/min or creatinine \<1.5 mg/dL; bilirubin \< 2 mg/dL. - aspartate transaminases (AST/SGOT) and alanine transaminases (ALT/SGPT) \<3 x upper limit of normal (ULN). At two weeks from biliary decompression, if the subject's serum AST/ALT remains greater 3x ULN, but has demonstrated a progressive decline, the subject may be enrolled into the trial and appropriate modification and dose adjustments will be made to the assigned regimen. Eligibility of subjects whose AST/ALT remain elevated 3x ULN, without demonstrating a downward trend, will be determined at the discretion of the trial principal investigators. - Subjects must be CA19-9 producers as defined by a pretreatment CA 19-9 \> 35 U/mL, when total bilirubin \<2 mg/dL. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
INCLUSION CRITERIA * Be 18 years of age or older. * Be able to understand and provide written informed consent or have a legally authorized representative (LAR). * Have an Eastern Cooperative Group (ECOG) performance status \< 2 (please see the appendix). * Have documentation of histologically confirmed adenocarcinoma. Biopsy must have been completed prior to start of treatment; additional biopsy is not required for the study. * Have clinical stage consistent with resectable or borderline resectable adenocarcinoma of the pancreas, based on CT or MRI findings. * Have adequate organ and bone marrow function, as defined by: * total leukocytes \>3 x10\^3/μL. * absolute neutrophil count (ANC) \>1.5x 10\^3/μL. * hemoglobin \>9 g/dL. * platelets \>100 x 10\^3/μL. * creatinine clearance \>60 mL/min or creatinine \<1.5 mg/dL; bilirubin \< 2 mg/dL. * aspartate transaminases (AST/SGOT) and alanine transaminases (ALT/SGPT) \<3 x upper limit of normal (ULN). At two weeks from biliary decompression, if the subject's serum AST/ALT remains greater 3x ULN, but has demonstrated a progressive decline, the subject may be enrolled into the trial and appropriate modification and dose adjustments will be made to the assigned regimen. Eligibility of subjects whose AST/ALT remain elevated 3x ULN, without demonstrating a downward trend, will be determined at the discretion of the trial principal investigators. * Subjects must be CA19-9 producers as defined by a pretreatment CA 19-9 \> 35 U/mL, when total bilirubin \<2 mg/dL. * Female patients must be postmenopausal (absence of menses for \> 1 year), surgically sterile, or have a negative pregnancy test and use at least one form of contraception for four weeks prior to Day 1 of the study, during study treatment and during the first four months after study treatment is discontinued. Male patients must be surgically sterile or use barrier contraception during the study and for four months after the last dose of any study drug. EXCLUSION CRITERIA * Has received more than two months of FOLFIRINOX or mFOLFIRINOX chemotherapy as first-line therapy. * No documentation of a CA19-9 value when total bilirubin \< 2 prior to initiation of chemotherapy. * Has received any additional chemotherapy and/or radiation within three years prior to study enrollment. * Has any previous history of another malignancy (other than cured basal or squamous cell carcinoma of the skin or cured in situ carcinoma of the cervix or localized prostate cancer with normal prostate specific antigen) within three years of study enrollment. * Uncontrolled comorbidities including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina, unstable cardiac arrhythmias, psychiatric illness, excessive obesity (BMI \>55) or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent. * Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. * Pregnant or breastfeeding patients or any patient with childbearing potential not using contraception four weeks prior to treatment.

Treatments Being Tested

DRUG

First-line Chemotherapy

The first-line therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) or best available standard of care.

DRUG

Second-line Chemotherapy

Second line therapies will be multi-agent and contain gemcitabine. Molecular profiling data from the initial endoscopic ultrasound (EUS)/ fine needle aspirate (FNA) biopsy may be used at the discretion of the treating physician.

RADIATION

Chemoradiation

50.4 Gy in 28 fractions.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT03322995), the sponsor (Medical College of Wisconsin), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT03322995 clinical trial studying?

This is an open-label, phase II study in patients with resectable and borderline resectable pancreas cancer. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT03322995?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT03322995?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT03322995. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT03322995. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.