This study will implement a new treatment regimen for patients with advanced and inoperable pancreatic cancer using chemotherapy combinations of Folfirinox or gemcitabine-nab paclitaxel (abraxane) followed by a short course of high dose radiation called Stereotactic Body Radiation Therapy (SBRT). While the chemotherapy is standard of care, the strategy of adding SBRT has not been investigated. An increase in the percentage of patients who can proceed to have surgery to remove their disease is anticipated with this approach.
This pilot study will evaluate safety and tolerability of neoadjuvant chemotherapy followed by SBRT. Patients with locally advanced pancreatic cancer (LAPC) and borderline pancreatic inoperable cancer will be assigned to one of two treatment arms based upon performance status and physician's discretion. The two treatment arms are: Folfirinox or gemcitabine-nab paclitaxel (abraxane). There are no study drugs as all treatments are based on standard clinical pathways. After two cycles of treatment patients will be restaged with CT scans or imaging. If the tumor remains resectable, borderline, or unresectable without progression of disease, then the patient will proceed to SBRT. Follow-up visits will continue every three months for up to one year or until progression of disease.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
SBRT will follow Folfirinox at the completion of Cycle 2 (if eligible).
SBRT will follow Gemcitabine nab-Paclitaxel at the completion of Cycle 2 (if eligible).
University of Alabama at Birmingham
Birmingham, Alabama, United States
Number of participants with adverse events as a measure of safety and tolerability
Initial dose of drug until 4 weeks following completion of therapy which may or may not include SBRT and follow-up. Adverse event reporting will be graded following the National Cancer Institute of Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
Time frame: Baseline up to two years
Progression-free survival
Progression-free survival is the duration of time from study entry to time of disease progression or death, whichever comes first.
Time frame: Baseline up to two years
Overall survival
Overall survival is the duration of time from study entry to time of death or the date of last contact.
Time frame: Baseline to two years
Rate of preoperative chemotherapy + radiotherapy completion
The rate will be determined from the measurement of lesions (maximum of 2 per organ with no more than 5 lesions total) from CT scans and magnetic resonance imaging within the study time frame.
Time frame: Baseline to two years
Proportion of participants undergoing surgery after preoperative chemoradiation therapy
Comparison of participants who underwent surgery versus those that did not following preoperative chemoradiation therapy
Time frame: Baseline to two years
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