The purpose of this study is to research the effects of delivering full-dose neoadjuvant multi-agent chemotherapy (folfirinox) followed by stereotactic body radiation therapy (SBRT) in patients with resectable pancreatic ductal adenocarcinoma (PDAC) in order to intensify local therapy and improve outcomes.
Primary Objectives: 1\. To assess one-year local control rates in patients with operable PDAC who receive neoadjuvant chemotherapy and SBRT Secondary Objectives: 1. To assess the following disease control endpoints: pathological response, disease-free survival, overall survival, failure pattern (local vs. distant) and time to development of distant metastases 2. To assess safety of the SBRT regimen Exploratory objectives 1. To obtain exploratory data correlating tumor response grade with changes in circulating tumor DNA levels following chemotherapy, SBRT, and surgery in patients with PDAC 2. To obtain exploratory data correlating circulating tumor DNA (ctDNA) changes with disease control endpoints (overall survival, disease-free survival, failure pattern, and time to development of distant metastases) 3. To obtain exploratory data on positron emission tomography (PET) and magnetic resonance imaging (MRI) findings and correlations with tumor response among patients treated on study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Patients will receive 5 fractions of SBRT delivered over a five-day period. Treatment may be delivered over 2 weeks, provided that the patient receives at least 2 fractions per week.
Participants in this trial will receive neoadjuvant and adjuvant FOLFIRINOX chemotherapy for 6 cycles (1 cycle = 14 days) per routine guidelines
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, United States
Local control rate among PDAC patients treated with neoadjuvant chemotherapy followed by SBRT
Time frame: 1 year after surgery date
Pathological tumor response grade
Time frame: Surgery Date (4 weeks [+/- 14 days] from end of SBRT)
Rate of margin negative resection
Time frame: Surgery Date (4 weeks [+/- 14 days] from end of SBRT)
Rate of progression free survival
Time frame: From surgery date to first documented date of progression, up to 5 years
Overall survival
Time frame: From surgery date to date of death, up to 5 years
Local control rate
Time frame: from date of surgery until date of first documented local failure, up to 5 years
Time to development of distant metastases
Time frame: From surgery date to date of first documented metastatic disease, up to 5 years
Site of first failure
Time frame: From surgery date to date of first documented metastatic disease, up to 5 years
Rate of grade 3-4 non hematological toxicity rates
Time frame: Date of first fraction of SBRT through 30 days (+/-14) after surgery date
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