Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Unresectable Pancreatic Cancer|
- local control rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]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 Positron Emission Tomography scan may be used to aid in diagnoses of local tumor recurrence.
- late toxicity rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]Toxicities will be graded using CTCAE criteria at specified timepoints.
|Study Start Date:||September 2008|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Stereotactic Radiation to Pancreas
Radiation: Stereotactic Body Radiotherapy
Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346410
|United States, Missouri|
|St. John's Mercy Medical Center|
|St. Louis, Missouri, United States, 63141|