This study wants to find out how safe and effective the use of Folfirinox combined with Stereotactic Body Radiation Therapy )(SBRT) is for the treatment of pancreatic cancer.
The study will be a prospective, non-randomized, single center, trial to assess the effects of FOLIRINOX chemotherapy with SBRT on locally advanced, non-resectable pancreatic cancer. Patients will either undergo a biopsy to confirm the diagnosis or have strong clinical suspicion of a new cancer or recurrence based on the recommendations of a multi-disciplinary GI oncology team. FOLFIRINOX with be delivered prior to SBRT for 4 cycles. Restaging imaging will occur prior to SBRT delivery. SBRT will be delivered using standard stereotactic techniques to a dose of 3200cGy at 650cGy per fraction delivered over 2 weeks. Additional adjuvant chemotherapy with be delivered at the physician's discretion. Patients will be reassessed both clinically and radiographically at 3 months, 6 months, 9 months and 12 months post-treatment. Quality of life analysis will occur at 3 month intervals after treatment. Blood will be drawn for exploratory biomarker analysis at strategic timepoints during treatment and followup. Following the initial imaging time points, standard surveillance will be employed with clinical assessment and imaging at 3 month intervals for the first 2 years post-treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
* Oxaliplatin 85 mg/m² for over 2 hours, * Leucovorin 400n mg/m² for over 2 hours, * Irinotecan 180 mg/m² for over 90 minutes, along with Leucovorin infusion * Fluorouracil 400 mg/m² as a fast infusion over 15 minutes * Fluorouracil 2400 mg/m² as a slow infusion over 46 hours
5 treatments of stereotactic ablative radiotherapy (SABR) over the course of two weeks with a minimum of 36 hours in between each treatment.
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Grade 3 or Higher Adverse Event(s) as a Measure of Safety and Tolerability
Number of Participants With Grade 3 or Higher Adverse Event(s) as a Measure of Safety and Tolerability. This is based on CTCAE to assess toxicity at specified time points by the treating physician.
Time frame: Assessed up to 24 months post treatment
Overall Response Rate for Participants as Assessed by Contrast-enhanced CT Scan of the Abdomen at 12 Months.
Response to therapy at 12 months post treatment as measured from CT Scan by modified RECIST criteria as follows; Response is measured as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD.
Time frame: Assessed at 3 months, 6 months, 9 months and 12 months post-treatment
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