PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples
- Conditions
- Pancreatic Cancer
- Interventions
- Drug: Gemcitabine/Nab-paclitaxel Treatment RegimenDrug: mFOLFIRINOX Treatment RegimenRadiation: Chemoradiation
- Registration Number
- NCT04683315
- Lead Sponsor
- Medical College of Wisconsin
- Brief Summary
This is an open-label, phase II study in patients with resectable and borderline resectable pancreatic cancer.
- Detailed 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 87
Not provided
- Has received 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 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Subtype diagnosis and classification: Basal Gemcitabine/Nab-paclitaxel Treatment Regimen 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. Subtype diagnosis and classification: Classical mFOLFIRINOX Treatment Regimen 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. Basal Group: Restaging: Response to Treatment Gemcitabine/Nab-paclitaxel Treatment Regimen After the first restaging evaluation, further treatment will be based on treatment response. Patients who demonstrate a response \[decline in carbohydrate antigen 19-9 (CA19-9) values\] and radiographic response, along with preserved performance status) will be maintained on the first line chemotherapy for an additional two months. Classical Group: Restaging: Response to Treatment mFOLFIRINOX Treatment Regimen After the first restaging evaluation, further treatment will be based on treatment response. Patients who demonstrate a response \[decline in carbohydrate antigen 19-9 (CA19-9) values\] and radiographic response, along with preserved performance status) will be maintained on the first line chemotherapy for an additional two months. Basal Group: Restaging: Patients with Stable Disease mFOLFIRINOX Treatment Regimen Patients who do not have a significant decline in CA19-9 values will be changed to a second-line therapy for an additional two months. Classical Group: Restaging: Patients with Stable Disease Gemcitabine/Nab-paclitaxel Treatment Regimen Patients who do not have a significant decline in CA19-9 values will be changed to a second-line therapy for an additional two months. Basal Group: Restaging: Local Disease Progression Chemoradiation Further treatment will be based on treatment response. If the patient has local disease progression amenable to surgical resection, he or she will receive chemoradiation, rather than continued chemotherapy, so the window of opportunity for surgical resection is not lost. Classical Group: Restaging: Local Disease Progression Chemoradiation Further treatment will be based on treatment response. If the patient has local disease progression amenable to surgical resection, he or she will receive chemoradiation, rather than continued chemotherapy, so the window of opportunity for surgical resection is not lost.
- Primary Outcome Measures
Name Time Method Subjects who receive PurIST classification-directed therapy. 12 weeks The number of subjects who receive PurIST classification-directed therapy and have a treatment response following 12 weeks of therapy.
- Secondary Outcome Measures
Name Time Method Treatment response for subjects with basal subtype tumors. 12 weeks The number of subjects with basal subtype tumors who have a treatment response.
Treatment response for subjects with classical subtype tumors. 12 weeks The number of subjects with classical subtype tumors who have a treatment response.
Subjects with basal subtype tumors who complete all intended neoadjuvant therapy and surgical therapy. One year The number of subjects completing all intended neoadjuvant therapy and surgical therapy.
Subjects with classical subtype tumors who complete all intended neoadjuvant therapy and surgical therapy. One year The number of subjects completing all intended neoadjuvant therapy and surgical therapy.
Trial Locations
- Locations (2)
HonorHealth Medical Group
🇺🇸Scottsdale, Arizona, United States
Froedtert & the Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States