Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Unresectable Pancreatic Cancer
This is a single institution, non-randomized, prospective, phase IV trial of SBRT for
unresectable pancreatic cancer.
Data collected will include patient demographics, pathology data, tumor stage, SBRT dose
fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence
data, and acute and late toxicities.
Follow up data will be collected during the patient's standard office visits. The
anticipated duration of this study is 5 years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
local control rate
Local recurrence is defined as tumor recurrence within the planning target volume. Local control rate will be evaluated by imaging techniques such as CT or MRI. Local recurrence will be defined as an increase of > 20% in tumor size. If necessary, a PET/CT scan may be used to aid in diagnoses of local tumor recurrence.
5 years
No
United States: Institutional Review Board
08-060
NCT01346410
September 2008
July 2012
Name | Location |
---|---|
St. John's Mercy Medical Center | Saint Louis, Missouri 63141 |