PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Medical College of Wisconsin
Study ID
NCT04683315
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • mFOLFIRINOX Treatment Regimen — DRUG
    This therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX).
  • Gemcitabine/Nab-paclitaxel Treatment Regimen — DRUG
    This regimen will be nab-paclitaxel and gemcitabine.

Study Details

This is an open-label, phase II study in patients with resectable and borderline resectable pancreatic cancer.

Key Dates

Start date
Apr 1, 2021
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
84 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Subtype diagnosis and classification: Basal
    Patients will be classified by (molecular) subtype (using the PurIST classifier) into two groups: basal and classical pancreatic cancer. Upon diagnosis, patients categorized as basal will receive two months of the Gemcitabine/Nab-paclitaxel Treatment Regimen.
  • Experimental: Subtype diagnosis and classification: Classical
    Patients will be classified by (molecular) subtype (using the PurIST classifier) into two groups: basal and classical pancreatic cancer. Patients in the classical group will receive two months of the mFOLFIRINOX Treatment Regimen.

Primary Outcome Measure

Subjects who receive PurIST classification-directed therapy. [ Time Frame: 12 weeks ]

Central Contacts

  • Medical College of Wisconsin Cancer Center Clinical Trials Office
    866-680-0505

Locations (2)

FacilityCityStateZIPSite coordinators
HonorHealth Medical GroupScottsdaleArizona85258-4566
Erkut Borazanci, MD
480-323-1350
Gayle Jameson, APNP
480-323-1350
Froedtert & the Medical College of WisconsinMilwaukeeWisconsin53226
Kathleen Christians, MD
414-955-1400

Find similar trials in Scottsdale, AZ

By condition

Related Studies