PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples
Medical College of Wisconsin
Summary
This is an open-label, phase II study in patients with resectable and borderline resectable pancreatic cancer.
Description
The study intervention involves molecular profiling Purity Independent Subtyping of Tumors (PurIST) subtyping of pretreatment Endoscopic Ultrasound Fine Needle Aspiration (EUS/FNA) samples to determine pancreatic cancer subtype. Neoadjuvant therapy is directed based on the molecular subtype (classical vs. basal). Patients with classical subtype will receive a standard chemotherapy (mFOLFIRINOX) and patients with basal subtype will receive an alternative standard therapy (gemcitabine/nab-paclitaxel).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria (for Screening) 1. Have suspicion of pancreas adenocarcinoma and plan for endoscopic biopsy. 2. Plan for endoscopic biopsy or agreeable to an additional EUS/FNA for research purposes, otherwise plan to obtain archival tissue for PurlST testing. 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. 4. Have an Eastern Cooperative Group (ECOG) performance status \< 2. 5. Have clinical s…
Interventions
- DrugmFOLFIRINOX Treatment Regimen
This therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX).
- DrugGemcitabine/Nab-paclitaxel Treatment Regimen
This regimen will be nab-paclitaxel and gemcitabine.
Locations (2)
- HonorHealth Medical GroupScottsdale, Arizona
- Froedtert & the Medical College of WisconsinMilwaukee, Wisconsin