Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Unresectable Pancreatic Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mercy Research
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Local Control Rate
Study Overview
Brief Summary
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of unresectable pancreatic cancer.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient age >= 18 years
- •Performance status of 0-3
- •Unresectable pancreatic cancer
- •Maximum tumor diameter < 7.5 cm
- •Signed study-specific consent form
Exclusion Criteria
- •Maximum tumor diameter > 7.5 cm
- •Prior radiotherapy to the upper abdomen
- •Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
- •Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
Arms & Interventions
A
Stereotactic Radiation to Pancreas
Intervention: Stereotactic Body Radiotherapy (Radiation)
Outcomes
Primary Outcomes
Local Control Rate
Time Frame: 5 years
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.
Secondary Outcomes
- Late Toxicity Rate(5 years)
Investigators
Kathy Baglan, MD
Radiation Oncologist
Mercy Research