NCT04683315 · Medical College of Wisconsin
PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples
(PANCREAS)
What this study is about
This is an where both patients and doctors know the treatment given, phase II study in patients with resectable and borderline resectable pancreatic cancer.
View original scientific description
This is an open-label, phase II study in patients with resectable and borderline resectable pancreatic cancer.
Interventions
DRUG
mFOLFIRINOX Treatment Regimen
This therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX).
DRUG
Gemcitabine/Nab-paclitaxel Treatment Regimen
This regimen will be nab-paclitaxel and gemcitabine.
Primary outcome measures
Subjects who receive PurIST classification-directed therapy.
Time frame: 12 weeks
The number of subjects who receive PurIST classification-directed therapy and have a treatment response following 12 weeks of therapy.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- (for Screening) 1. Have suspicion of pancreas adenocarcinoma and plan for endoscopic biopsy. Agrees to additional EUS biopsy to be performed at the first-restaging timepoint and tissue collection from surgical specimen. 2. Have a carbohydrate antigen 19-9 (CA19-9) level greater than 35 mg/dL regardless of total bilirubin level. Inclusion Criteria (for Treatment) 1. Be 18 years of age or older. 2. Be able to understand and provide written informed consent or have a legally authorized representative (LAR). 3. Have documentation of histologically confirmed adenocarcinoma. Biopsy must have been completed prior to start of treatment Have an Eastern Cooperative Group (ECOG) performance status \< 2 (please see the appendix). 4. Have documentation of histologically confirmed adenocarcinoma. Biopsy must have been completed prior to start of treatment. 5. Have clinical stage consistent with resectable or borderline resectable adenocarcinoma of the pancreas, based on CT or M
Where
- Scottsdale, Arizona
- Milwaukee, Wisconsin
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 5, 2026 · Source of record for eligibility and locations