Pancreatic Cancer Adaptive Neoadjuvant Chemotherapy Trial

Conditions

First-line Chemotherapy — DRUG
The first-line therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) or best available standard of care.
Second-line Chemotherapy — DRUG
Second line therapies will be multi-agent and contain gemcitabine. Molecular profiling data from the initial endoscopic ultrasound (EUS)/ fine needle aspirate (FNA) biopsy may be used at the discretion of the treating physician.
Chemoradiation — RADIATION
50.4 Gy in 28 fractions.

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

Experimental: Restaging: Response to Treatment
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.
Experimental: Restaging: Patients with Stable Disease
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.
Experimental: Restaging: Local Disease Progression
After the first restaging evaluation, further treatment will be based on treatment response. If, at the initial restaging, 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.

Completion of all intended neoadjuvant therapy and surgical therapy [ Time Frame: Five years. ]

Medical College of Wisconsin Clinical Cancer Center
414-805-8900
[email protected]

Facility	City	State	ZIP	Site coordinators
Froedtert & the Medical College of Wisconsin	Milwaukee	Wisconsin	53226	Froedtert & the Medical College of Wisconsin Clinical Cancer Center [email protected] 414-805-8900 Kathleen Christians, MD (PRINCIPAL_INVESTIGATOR)

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