Adaptive Modification of Neoadjuvant Therapy Based on Clinical Response in Patients With Localized Pancreatic Cancer
Medical College of Wisconsin
Summary
This is an open-label, phase II study in patients with resectable and borderline resectable pancreas cancer.
Description
Patients will receive standard chemotherapy and chemoradiation for pancreatic cancer. The study intervention is an adaptive approach which modifies systemic therapy based on clinical assessments of treatment response. Treatment response will be assessed by imaging (CT scan), biomarker \[serum cancer antigen (CA)19-9\] and performance status assessment \[short physical performance battery (SPPB) and Center for Epidemiologic Studies Depression Scale (CES-D) evaluations\] at the first restaging assessment. Treatment response will be categorized as: 1. response; 2. stable disease; 3. local disea…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
INCLUSION CRITERIA * Be 18 years of age or older. * Be able to understand and provide written informed consent or have a legally authorized representative (LAR). * Have an Eastern Cooperative Group (ECOG) performance status \< 2 (please see the appendix). * Have documentation of histologically confirmed adenocarcinoma. Biopsy must have been completed prior to start of treatment; additional biopsy is not required for the study. * Have clinical stage consistent with resectable or borderline resectable adenocarcinoma of the pancreas, based on CT or MRI findings. * Have adequate organ and bone ma…
Interventions
- DrugFirst-line Chemotherapy
The first-line therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) or best available standard of care.
- DrugSecond-line Chemotherapy
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.
- RadiationChemoradiation
50.4 Gy in 28 fractions.
Location
- Froedtert & the Medical College of WisconsinMilwaukee, Wisconsin