A Prospective Pilot Clinical Trial of Simulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy in Patients With Cancer-Related Celiac Pain
Case Comprehensive Cancer Center
Summary
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.
Description
Celiac plexus nerve pain, a type of abdominal pain, is common in people with pancreatic cancer. In fact, 70-80% of these people say they have very bad, or debilitating, pain in the lower part of their abdomen and/or the area behind their abdomen where they were diagnosed with pancreatic cancer (1). Recently, a type of treatment called celiac plexus radioablation, which is done using a type of radiation called stereotactic body radiotherapy (SBRT), has been recognized as a new standard-of-care therapy option for these people (2-4). However, celiac plexus radioablation takes a long time to plan…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Inventor…
Interventions
- OtherSimulation-free workflow
Pre-existing diagnostic images (CTs, PET/CTs, or MRIs) will be imported into the online treatment planning system called Ethos. The Ethos platform and online adaptive radiation therapy (ART) will be utilized at the time of treatment planning and delivery.
- RadiationCeliac plexus SBRT
Participants will receive SBRT per standard of care. This treatment visit will take up to 1.5 hours.
Location
- University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio