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Adaptive Chemotherapy for Pancreatic Cancer

This study is testing an adaptive approach to treating pancreatic cancer that can be removed by surgery or is borderline resectable (meaning it's close to important blood vessels). You would receive standard chemotherapy, such as FOLFIRINOX (a combination of 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin) or another standard treatment, followed by chemoradiation (radiation therapy combined with chemotherapy). The unique part of this study is that your treatment plan may change based on how your cancer responds, as measured by imaging (CT scans), a blood test called CA19-9, and your physical well-being. If your cancer responds well, you'll continue the same chemotherapy. If it's stable, you might switch to a different chemotherapy. If the cancer grows locally, you'll receive chemoradiation. If it spreads, you would leave the trial. The main goal is to see how many patients complete all planned chemotherapy and surgery. This study is open to adults aged 18 and older with confirmed pancreatic adenocarcinoma and good physical health. The study is currently unclear on its recruitment status and plans to enroll 125 participants.

Study design
This is an open-label, Phase 2 study for 125 participants with resectable or borderline resectable pancreatic cancer. The treatment approach is adaptive, meaning it changes based on how your cancer responds.
What's involved
You would receive chemotherapy and chemoradiation. Your treatment response will be assessed by CT scans, blood tests (CA19-9), and physical assessments (SPPB and CES-D evaluations) at the first restaging assessment.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, completion of all intended neoadjuvant therapy and surgical therapy, will be measured at five years.

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NCT03322995

Pancreatic Cancer Adaptive Neoadjuvant Chemotherapy Trial

Recruiting
PHASE2Ages 18+InterventionalTreatment
Medical College of Wisconsin
~125 participants
Updated 2026-01-08 on ClinicalTrials.gov
What's tested:First-line ChemotherapySecond-line ChemotherapyChemoradiation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Completion of all intended neoadjuvant therapy and surgical therapy
Measured over Five years.

Conditions

Pancreatic Cancer

Explore related trials

Pancreatic Carcinoma

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Kathleen Christians, MD · PRINCIPAL_INVESTIGATOR · Professor

Who to contact

Medical College of Wisconsin Clinical Cancer Center
[email protected]
414-805-8900
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Completion of all intended neoadjuvant therapy and surgical therapyFive years.

    This measure is the number of subjects completing all intended neoadjuvant therapy and surgical therapy.