Recruiting
Phase 2

Neoadjuvant Chemotherapy

Sponsor:

Medical College of Wisconsin

Code:

NCT03322995

Conditions

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

First-line Chemotherapy

Second-line Chemotherapy

Chemoradiation

Study Details

Brief summary:

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

Conditions

Pancreatic Cancer

Study ID

NCT03322995

Start date

Jun 21, 2018

Status verified date

Jan, 2026

Completion date

Jun 1, 2032

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

125 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Restaging: Response to Treatment

After the first restaging evaluation, further treatment will be based on treatment response. Patients who demonstrate a response \[decline in carbohydrate antigen 19-9 (CA19-9) values\] and radiographic response, along with preserved performance status) will be maintained on the first line chemotherapy for an additional two months.

experimental: Restaging: Patients with Stable Disease

Patients who do not have a significant decline in CA19-9 values will be changed to a second-line therapy for an additional two months.

experimental: Restaging: Local Disease Progression

After the first restaging evaluation, further treatment will be based on treatment response. If, at the initial restaging, the patient has local disease progression amenable to surgical resection, he or she will receive chemoradiation, rather than continued chemotherapy, so the window of opportunity for surgical resection is not lost.

Interventions

First-line Chemotherapy

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

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.

Chemoradiation

50.4 Gy in 28 fractions.

Primary outcome measure

  • Completion of all intended neoadjuvant therapy and surgical therapy [ Time Frame: Five years. ]

Central Contacts and Locations

Central contacts

Medical College of Wisconsin Clinical Cancer Center

414-805-8900cccto@mcw.edu

Locations

Froedtert & the Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Froedtert & the Medical College of Wisconsin Clinical Cancer Center

414-805-8900cccto@mcw.edu

Principal Investigator:

Kathleen Christians, MD

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Keywords

  • Neoadjuvant
  • pancreatic adenocarcinoma
  • pancreas cancer
  • pancreatic cancer
  • molecular profiling
  • CA19-9
  • surgery
  • MCW

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-01-08.