A Prospective Pilot Clinical Trial of Simulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy in Patients With Cancer-Related Celiac Pain
Participants who are experiencing abdominal pain due to having cancer in their pancreas may be eligible for this research study. For this type of pain, doctors often recommend radiation therapy to help with the pain. This radiation therapy is called stereotactic body radiotherapy (SBRT). Preparing for SBRT typically takes a week or longer. In this research study, doctors want to test a new workflow in order to shorten the time it takes for participants to receive SBRT to help with their pain. Doctors typically determine how to administer the SBRT by doing a simulation, which requires a CT (Computerized Tomography) scan. The CT scan is used to create a treatment plan. It can take time to schedule this CT scan and then it takes 5-10 days to create a treatment plan. A way to reduce the planning time for SBRT is to use the CT scan that participants had when their cancer was diagnosed to plan the SBRT. This new workflow can cut down the time it takes to schedule another CT scan and plan for and deliver SBRT. The workflow where doctors use a pre-existing CT scan is called CTsim-free treatment planning. CTsim-free treatment planning is what is being tested in this research study.
• Participants must have histologically or cytologically confirmed cancer that is metastatic or unresectable, and considered appropriate per the treating physician to receive celiac plexus SBRT.
• Age \>18 years. Because no data are currently available on the use of celiac axis SBRT in participants ≤18 years of age, children are excluded from this study.
• Performance status: ECOG Performance status ≤ 3
• Severe retroperitoneal pain syndrome (radiates from the lower back to the upper abdomen, belt- like distribution), intensity of at least 5 on 11-point Brief Pain Inventory (BPI, average pain) scale despite analgesic use. Note: previous use of celiac plexus block/neurolysis for pain control is allowed and will be recorded
• Participants must have anatomical involvement of the celiac plexus on the diagnostic CT, PET/CT, or MRI. This includes:
‣ Any pancreatic cancer
⁃ Any other cancer that on imaging demonstrates either gross involvement of the celiac blood vessels or celiac plexus on imaging OR haziness around the celiac blood vessels that typically implies tumor engulfment.
• Prior chemotherapy or biological treatment is allowed, but any active oncological treatment must be stopped at least 1 week prior to radiation therapy and renewed at least 1 week following radiation therapy.
• Participants must have the ability to understand and the willingness to sign a written informed consent document.
• Participants must have a diagnostic CT, PET/CT, or MRI of the abdomen and pelvis, with or without contrast, acquired \< 28 days prior to the study consent. This diagnostic scan, to be used for pre-plan formation, must fully visualize the celiac plexus target intended for simulation-free treatment, with full axial field-of-view at the axial levels for treatment. The scan must be of sufficient clinical quality for the treating physician to delineate the target for treatment.