An interventional study of Treatment plan in Advanced Cancer and Pancreatic Cancer, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment
This is a prospective, single-arm, pilot feasibility clinical trial designed to evaluate the feasibility and safety of a simulation-free adaptive radiotherapy workflow to enable single-session celiac plexus SBRT planning and delivery. In this trial, the treatment itself is non-investigational (standard-of-care celiac plexus SBRT) but the treatment workflow (simulation-free, using adaptive radiotherapy to compress treatment planning and delivery into a single session) is novel. Investigators hypothesize the successful completion of the simulation-free ART workflow through treatment delivery in the first on-table treatment attempt for at least 80% of patients.
A standard treatment for pain caused by cancer affecting the celiac plexus (a group of nerves in the upper abdomen behind the stomach and pancreas) is a type of radiation therapy called stereotactic body radiotherapy (SBRT). In the usual process for this type of radiation treatment, the patient would first have a special radiation planning scan called a computer tomography simulation (CTsim) to create a personalized treatment plan. The planning process usually takes 5 to 10 days, which means treatment may begin up to 2 weeks after the initial CTsim scan. Recent technology has allowed for treatment to be planned without a separate CTsim scan, called a CTsim-free workflow. In this study, investigators will use pre-existing scans (such as diagnostic imaging) to create the patient's treatment plan. On the day of treatment, the care team will use a technique called Adaptive Radiotherapy (ART) to adjust the plan based on the patient body's position and anatomy that day, allowing planning and treatment to happen in a single visit.
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This study's planned enrollment of 5 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
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Exclusion Criteria:
Other: Treatment plan
Simulation-free radiation treatment planning, in which pre-existing diagnostic images are used to generate a radiation treatment pre-plan (as opposed to acquiring planning-specific image sets). This will be paired with the use of online adaptive radiotherapy (ART) to refine the pre-plan to create a final plan that matches the on-table internal target and gastrointestinal anatomy observed with on-board imaging on the day of treatment. This enables single-session celiac plexus SBRT planning and delivery.
Successful treatment plan workflow of 80% of patients
The feasibility and safety of the simulation-free adaptive radiotherapy workflow for celiac plexus SBRT for clinical use. Feasibility defined as the successful completion of the simulation-free ART workflow through treatment delivery in the first on-table treatment attempt for at least 80% of patients. All of the following criteria must be met to be deemed feasible: * Meets all priority 1 OAR constraints * Meets a PTV\_Opt\_2500 and PTV\_Opt\_2000 priority 2 constraints * Patient specific QA pass as per institutional standards * Patient able to tolerate treatment position for CBCT and entirety of treatment process. If a break is required and the patient is repositioned, the ART process must repeat from CBCT acquisition * Complete delivery of all planned monitor units
Time frame: 1 year
Component time
Average time required for each component of the simulation-free ART workflow, including but not limited to plan generation using diagnostic imaging, pre-treatment activities (e.g., on-table patient setup/imaging, dose prediction, segmentation of daily contours, plan optimization and evaluation), and treatment delivery.
Time frame: 1 year
Dosimetric comparison of radiation plans
Dosimetric comparison of radiation plans created on traditional offline CBCT images with those created using the simulation-free ART workflow (i.e., comparison of target coverage, sparing of organs-at-risk).
Time frame: 1 year
Frequency of online re-adaptation
Frequency of online re-adaptation within the sim-free workflow. Readaptation defined as the need to regenerate a treatment plan after an initial plan had been generated that does not satisfy treatment parameters.
Time frame: 1 Year
Patient satisfaction
Overall patient satisfaction with celiac plexus SBRT using a simulation-free, adaptive radiotherapy workflow. This will be assessed using the Radiotherapy Experience Questionnaire (RTEQ) which is a validated RT experience questionnaire that reports patient experiences with the overall treatment process by answering statements on a scale of strongly agree to strongly disagree. Given that this is a novel workflow/process, the results of the questionnaire will shed light on their overall experience.
Time frame: 1 year
Change in the Brief Pain Inventory pain scale
Change in Brief Pain Inventory pain scale, where on a scale 0 is "No Pain" and 10 is "Pain as bad as you can imagine", recorded in the pain diary at baseline/screening, day of SBRT prior to treatment, and 6 weeks after sim-free celiac plexus SBRT.
Time frame: 6 Weeks
Change in Amount of Pain Medication
Change in the amount of pain medications (Morphine equivalents) recorded in the pain diary at baseline/screening, day of SBRT prior to treatment, and 6 weeks after sim-free celiac plexus SBRT. Patients will record number of medication units taken (unit of medication is a tablet or capsule, a millilitre (mL) of liquid, a suppository, or a patch).
Time frame: 6 weeks
TCAE Grade 3+ Toxicity
Any CTCAE Grade 3+ Toxicity at 6 weeks related to the SBRT treatment.
Time frame: 6 weeks
Cost of workflow
The overall cost of simulation free workflow compared to select retrospective cases treated on conventional workflow. Timepoints include simulation, planning, treatment, and follow up. Components include planning, therapist, clinician.
Time frame: 1 year
Mean difference between diagnostic and ETHOS plans (COM)
Mean difference in location between diagnostic, planning, and hypersight scans at each time point for select organs at risk. These include liver, stomach, duodenum, pancreas, kidneys, small bowel, aorta, and large bowel. Rigid registration to spinal column as baseline (or aorta). Metrics will include center of mass (COM).
Time frame: 1 year
Mean difference between diagnostic and ETHOS plans (DTA)
Mean difference in location between diagnostic, planning, and hypersight scans at each time point for select organs at risk. These include liver, stomach, duodenum, pancreas, kidneys, small bowel, aorta, and large bowel. Rigid registration to spinal column as baseline (or aorta). Metrics will include distance to agreement (DTA).
Time frame: 1 year
Mean difference between diagnostic and ETHOS plans (ASSD)
Mean difference in location between diagnostic, planning, and hypersight scans at each time point for select organs at risk. These include liver, stomach, duodenum, pancreas, kidneys, small bowel, aorta, and large bowel. Rigid registration to spinal column as baseline (or aorta). Metrics will include average symmetric surface distance (ASSD).
Time frame: 1 year
Mean difference between diagnostic and ETHOS plans (DSC)
Mean difference in location between diagnostic, planning, and hypersight scans at each time point for select organs at risk. These include liver, stomach, duodenum, pancreas, kidneys, small bowel, aorta, and large bowel. Rigid registration to spinal column as baseline (or aorta). Metrics will include dice for volume overlap (DSC).
Time frame: 1 Year
Mean difference between diagnostic and ETHOS plans (DVF)
Mean difference in location between diagnostic, planning, and hypersight scans at each time point for select organs at risk. These include liver, stomach, duodenum, pancreas, kidneys, small bowel, aorta, and large bowel. Rigid registration to spinal column as baseline (or aorta). Metrics will include deformation vector field (DVF).
Time frame: 1 Year
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University Health Network, Toronto