Advanced CancerCeliac SRSNCT07636382
Simulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy in Patients With Cancer-Related Celiac Pain
A study testing Treatment plan in people with Advanced Cancer and Pancreatic Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Pancreatic Cancer
- What is being tested?
- Treatment plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jun 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 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 subjects ≤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.
- Subjects 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 should be stopped at least 1 week prior to radiation therapy and renewed at least 1 week following radiation therapy.
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
- Subjects must have a diagnostic CT of the abdomen and pelvis, with or without contrast, acquired < 28 days prior to the study consent.
Who cannot join
- In ability to tolerate lying supine and still for at least 45 minutes.
- Performance status: ECOG Performance status of 4.
- Previous radiotherapy to the upper abdomen overlapping with the projected site of treatment.
- Pregnant or breastfeeding women are excluded from this study.
- Subjects 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Michael Yan
About this study
Official title: A Prospective Pilot Clinical Trial of Simulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy in Patients With Cancer-Related Celiac Pain
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.
Read the detailed description
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.
- Conditions
- Advanced Cancer, Pancreatic Cancer
- Being tested
- Treatment plan
- Keywords
- SBRT, Celiac, Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms, Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment planOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Sim-free ART workflow | Experimental | Not described Receives: Other: Treatment plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (13)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 6 weeks
TCAE Grade 3+ Toxicity
Any CTCAE Grade 3+ Toxicity at 6 weeks related to the SBRT treatment.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start4 Jun 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636382
- Sponsor's protocol ID
- 25-5377
- Acronym
- Celiac SRS
- Status last verified
- Jul 2026
- First submitted
- 26 May 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Clinical Trial of Simulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy in Patients With Cancer-Related Celiac Pain
- ClinicalTrials.gov ID
- NCT07636382
- Acronym / sponsor ID
- Celiac SRS / 25-5377
- Conditions
- Advanced Cancer, Pancreatic Cancer
- Keywords
- SBRT, Celiac, Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 4 Jun 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sim-free ART workflow | Experimental | Other: Treatment plan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects 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 subjects ≤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.
- Subjects 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.
Key exclusion criteria (6 listed)
- In ability to tolerate lying supine and still for at least 45 minutes.
- Performance status: ECOG Performance status of 4.
- Previous radiotherapy to the upper abdomen overlapping with the projected site of treatment.
- Pregnant or breastfeeding women are excluded from this study.
- Subjects with conditions associated with increased risk of side effects from radiation such as inflammatory bowel disease and scleroderma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment planSimulation-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. | Other | Sim-free ART workflow |
Primary outcome
Successful treatment plan workflow of 80% of patients
Time frame: 1 year
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
13 secondary outcomes
Component time
Time frame: 1 year
Dosimetric comparison of radiation plans
Time frame: 1 year
Frequency of online re-adaptation
Time frame: 1 Year
Patient satisfaction
Time frame: 1 year
Change in the Brief Pain Inventory pain scale
Time frame: 6 Weeks
Change in Amount of Pain Medication
Time frame: 6 weeks
TCAE Grade 3+ Toxicity
Time frame: 6 weeks
Cost of workflow
Time frame: 1 year
Mean difference between diagnostic and ETHOS plans (COM)
Time frame: 1 year
Mean difference between diagnostic and ETHOS plans (DTA)
Time frame: 1 year
Mean difference between diagnostic and ETHOS plans (ASSD)
Time frame: 1 year
Mean difference between diagnostic and ETHOS plans (DSC)
Time frame: 1 Year
Mean difference between diagnostic and ETHOS plans (DVF)
Time frame: 1 Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment plan in people with Advanced Cancer and Pancreatic Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Yan ((416) 946-2320, michael.yan@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful treatment plan workflow of 80% of patients (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.