Recruiting
Phase 1

SBRT

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT07117032

Conditions

Pancreatic Cancer

Retroperitoneal Pain Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Simulation-free workflow

Celiac plexus SBRT

Study Details

Brief 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.

Conditions

Pancreatic Cancer

Retroperitoneal Pain Syndrome

Study ID

NCT07117032

Start date

May 12, 2026

Status verified date

Jul, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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.

Exclusion Criteria:

  • Prior radiotherapy to the upper abdomen.
  • Previous radiotherapy to the upper abdomen overlapping with the projected site of treatment.
  • Pregnant or breastfeeding women are excluded from this study.
  • Participants with conditions associated with increased risk of side effects from radiation such as inflammatory bowel disease and scleroderma.
  • Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. If pregnancy test is not clinically indicated as determined by treating physician or protocol principal investigator, documentation of this exception is sufficient in lieu of a pregnancy test.

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Simulation-free treatment delivery of celiac plexus SBRT

Interventions

Simulation-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.

Celiac plexus SBRT

Participants will receive SBRT per standard of care. This treatment visit will take up to 1.5 hours.

Primary outcome measure

  • Feasibility of the simulation-free adaptive radiotherapy workflow, as measured by rate of successful completion of treatment [ Time Frame: At treatment visit, 1.5 hours ]
  • Feasibility of the simulation-free adaptive radiotherapy workflow, as measured by rate of compliance with priority level 1 dose constraints [ Time Frame: At treatment visit, 1.5 hours ]

Central Contacts and Locations

Central contacts

Lauren Henke, MD, MSCI

(218) 234 -6429lauren.henke@uhhospitals.org

Locations

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Lauren Henke, MD, MSCI

218-234-6429lauren.henke@uhhospitals.org

Principal Investigator:

Lauren Henke, MD, MSCI

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

  • Abdominal pain
  • Stereotactic Body Radiotherapy
  • Celiac pain
  • Celiac plexus pain ablation
  • SBRT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-07-20.