Phase I Study of Stereotactic Body Radiation Therapy and 5-Fluorouracil, Oxaliplatin and Irinotecan (FOLFIRINOX) in the Neoadjuvant Therapy of Pancreatic Cancer
The current standard of care for treating early stage pancreatic cancer involves surgery
followed by chemotherapy and chemoradiotherapy using conventional fractionated external beam
radiation therapy (EBRT). Despite the use of this standard treatment, the outcome for
patients whose pancreatic cancers have been surgically removed remains poor. Patients with
more advanced pancreatic cancers may experience even more inferior outcomes due to the
difficulty to resect the cancer completely. In this particular group of patients,
chemotherapy and radiation are offered to improve the resectability of the cancer.
Traditional chemotherapy used in the treatment of pancreatic cancer has included drugs such
as gemcitabine. Recently, a chemotherapy regimen called Folfirinox has been used in the
treatment of advanced pancreatic cancer. Fofirinox is also associated with improved
outcomes when compared to gemcitabine in this particular group of patients.
Stereotactic body radiotherapy (SBRT) uses a higher dose of radiation to the cancer, but the
treatment lasts for a significantly shorter period of time compared to conventional
radiation. SBRT has advantages over conventional radiation that include: shorter duration of
therapy (one to three days versus two to five weeks) and the ability to deliver full doses
of chemotherapy. Studies evaluating SBRT for patients with pancreatic cancer have shown
that SBRT is as effective as conventional radiation with less toxicity. SBRT combined with
chemotherapy has been very well tolerated in patients with pancreatic cancer.
This study will ask whether giving chemotherapy with Folfirinox followed in short sequence
by radiation therapy using a modified type of radiation, called Stereotactic Body Radiation
Therapy (SBRT), is a feasible and safe approach. Also the investigators would like to see
if this approach can improve the outcomes of patients who may undergo surgery for their
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated total dose of stereotactic body radiation to patients with resectable or borderline resectable pancreas cancer following Folfirinox chemotherapy
A standard 3 + 3 design will be used for evaluating the safety and tolerability of SBRT radiation doses. Any grade 3 liver, gastric, small bowel or spinal cord toxicity or any grade 4 toxicity (hematologic or other non-hematologic except for diarrhea) will be considered a dose limiting toxicity (DLT). Each cohort will consist of 3 patients, unless 1 of the patients experiences a DLT in which case the cohort will be expanded to 6 patients. The maximum tolerated dose (MTD) will be defined as the dose level below that which results in a DLT in 2 or more of the 6 patients in a cohort.
Natalyn Hawk, MD
Emory University Winship Cancer Institute
United States: Institutional Review Board
|Natalyn Hawk, MD||Atlanta, Georgia 30322|