Actively Recruiting
Pancreatic Cancer Adaptive Neoadjuvant Chemotherapy Trial
Led by Medical College of Wisconsin · Updated on 2026-01-08
125
Participants Needed
1
Research Sites
727 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, phase II study in patients with resectable and borderline resectable pancreas cancer.
CONDITIONS
Official Title
Pancreatic Cancer Adaptive Neoadjuvant Chemotherapy Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or older.
- Able to understand and provide written informed consent or have a legally authorized representative.
- Eastern Cooperative Group (ECOG) performance status less than 2.
- Histologically confirmed pancreatic adenocarcinoma with biopsy completed before treatment.
- Clinical stage consistent with resectable or borderline resectable pancreatic adenocarcinoma based on CT or MRI.
- Adequate organ and bone marrow function, including specified blood cell counts and liver and kidney function.
- CA19-9 biomarker level greater than 35 U/mL when total bilirubin is less than 2 mg/dL.
- Female patients must be postmenopausal, surgically sterile, or have a negative pregnancy test and use contraception during and after treatment.
- Male patients must be surgically sterile or use barrier contraception during and after treatment.
You will not qualify if you...
- Received more than two months of FOLFIRINOX or mFOLFIRINOX chemotherapy as first-line therapy.
- No documented CA19-9 value with total bilirubin less than 2 prior to starting chemotherapy.
- Received chemotherapy or radiation within three years before enrollment.
- History of other malignancies within three years except certain cured skin, cervical, or prostate cancers.
- Uncontrolled serious illnesses, active infections, psychiatric illness, excessive obesity (BMI over 55), or inability to comply with study.
- Known infection with HIV, hepatitis B, or hepatitis C.
- Pregnant or breastfeeding, or not using contraception if of childbearing potential.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Medical College of Wisconsin Clinical Cancer Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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