New study tailors chemo and radiation for pancreatic cancer patients
NCT ID NCT03322995
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests an adaptive treatment plan for people with localized pancreatic cancer. Doctors adjust chemotherapy and radiation based on how the tumor responds, aiming to get more patients to successful surgery. The study enrolls 125 adults with resectable or borderline resectable cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chemotherapy (FOLFIRINOX, gemcitabine) and radiation
- What this could lead to
- If successful, this approach could help more patients with pancreatic cancer complete treatment and undergo surgery, potentially improving survival.
- What could go wrong
- This is a phase 2 trial with only 125 participants, so results are preliminary. Pancreatic cancer is aggressive, and the therapy may not work for everyone or may cause significant side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 125 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2018
- Expected to finish
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Jun 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Froedtert & the Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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