Division of Surgical Oncology
A Prospective Phase II Trial of Molecular Profiling to Guide Neoadjuvant
Therapy for Resectable and Borderline Resectable Adenocarcinoma
of the Pancreatic Head, Neck or Uncinate Process
Personalized Medicine Clinical Trial for Pancreatic Cancer
Background: This trial takes a novel, personalized, neoadjuvant approach to treatment of pancreatic cancer. Six specific molecular targets have been identified that are predictive of chemosensitivity to agents commonly used to treat pancreatic cancer today. Investigators will analyze the individual patient's tumor for these molecular target(s) and individualize the neoadjuvant treatment based on the immunohistochemistry and quantitative reverse transcriptase PCR data.
Eligibility/Treatment Schema: Eligible patients include those with known or suspected resectable or borderline resectable adenocarcinoma of the pancreatic head, neck or uncinate process. Patients will undergo endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA) of their tumors and those samples which are positive for adenocarcinoma will undergo molecular profiling. The patient will then undergo neoadjuvant therapy based on their tumor's molecular profile. If no profile is discernable, the patient will receive neoadjuvant therapy based on current standard of care. Those patients who demonstrate stable disease or treatment response by biochemical, clinical and radiologic measures will be offered resection. The primary objective is to compare resectability rate with targeted neoadjuvant therapy to historical results utilizing neoadjuvant therapy that is non-targeted. Please refer to the treatment schemas: Resectable (Figure A) and Borderline Resectable (Figure B); and the molecular profiling algorithms: FNA profiling (Figure C), Resection Profiling, no previous XRT (Figure D), and Resection Profiling, previous XRT (Figure E).
Contacts/Referrals: If you have specific questions regarding this clinical trial, you may contact any of the following investigators listed below. If you wish to refer a patient for this study, you may contact any one of the individual investigators or schedule the patient through our journey coordinator, Gail Laschen.
Gail Laschen - Patient Scheduling/Intake
Ann Dwyer – Research Nurse Coordinator
Kathleen Christians, MD - Surgical Oncology
Douglas B. Evans, MD – Surgical Oncology
Paul Ritch, MD - Medical Oncology
Ben George, MD – Medical Oncology
Beth Erickson, MD - Radiation Oncology
Tracy Kelly, MD – Radiation Oncology