Phase II Study of First-line Stereotactic Body Radiation Therapy (SBRT) in Patients With Non-Metastatic Unresectable Pancreatic Cancer
The standard treatment for cancer of the pancreas is surgery (if possible), external beam
radiation therapy and/or chemotherapy. These standard treatments are not a cure and often
extend life by just a few months. Recently, a new approach has been developed, called
stereotactic body radiation therapy (SBRT). Based on the results of earlier studies using
SBRT, the study doctors at Moffitt feel this is a reasonable alternative to the standard
treatment for your disease.
Stereotactic body radiation therapy (SBRT) delivers high radiation doses to the tumor every
day for 5 days which gives the usual 5-6 week course of radiation in less than a week. It
has also been shown to have much less side effects.
The purpose of this study is to see if SBRT will be a better way to treat pancreas cancer
and to find out what effects, good and/or bad, this treatment will have on you and your
Six patients will be asked to be part of a subgroup called TBRI (Tissue, Blood, Research
Imaging). In this subgroup, the investigators want to study if there is early death of tumor
cells from the treatment by looking at the tumor using PET/CT scans and biopsies, and by
testing your body's white blood cells taken by a procedure called leukapheresis. You do not
have to take part in the TBRI subgroup to get treatment on this study with SBRT.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Overall Survival (OS)
Patients will be followed for 36 months to determine overall survival even after completion of the experimental portion of the protocol. Patients will be followed every 3 months. All patients will be referred for chemotherapy at the completion of radiation.
Ravi Shridhar, M.D., Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration