ClinicalTrials.gg
RecruitingNCT07117032Updated Sep 22, 2026

Simulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy (SBRT) in Participants With Cancer-Related Celiac Pain

A Phase 1 interventional study of Simulation-free workflow and Celiac plexus SBRT in Pancreatic Cancer and Retroperitoneal Pain Syndrome, sponsored by Case Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Case Comprehensive Cancer Center · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 6 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 17 studies in Pancreatic Neoplasms by Case Comprehensive Cancer Center — 4 open to participants now, 5 under way, 1 of them phase 3. Pancreatic Neoplasms · Case Comprehensive Cancer Center.

Planned enrollment
10th of 13
5 · median 20
Started
2026
the only one that year
Phase 1
5 of 17
1 open now
Registered
16th of 17
by date

Among the 17 studies in Pancreatic Neoplasms by Case Comprehensive Cancer Center, this one is the 10th largest by planned enrollment of the 13 interventional ones that give a count, is the only one that started in 2026, is one of 5 in phase 1, and was the 16th registered.

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.

This study's planned enrollment of 5 is below the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Open to participants now

4 of the 17 studies in Pancreatic Neoplasms by Case Comprehensive Cancer Center are open now, in 1 country. Each count lists the studies.

All 4 open studies →

Where they have run

Who these studies take

Of the 746 Pancreatic Neoplasms studies recruiting now, 479 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 17 studies in Pancreatic Neoplasms by Case Comprehensive Cancer Center, or all of them as a file.
02

Study 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.

Read the detailed 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 and deliver when compared to traditional treatment approaches, which don't require so much time and so many visits (5). A better workflow is needed to make treatment planning and delivery happen faster. This better workflow should make things easier on people who are experiencing this severe pain and help them start treatment faster to feel better sooner.

One way to create this better workflow for celiac plexus radioablation is to use single-fraction SBRT and to use simulation-free radiation treatment planning. For this type of workflow, pre-existing diagnostic images are used to make the treatment plan, rather than making people get new images before they can start getting treated for their pain (6). This workflow uses an online tool called online adaptive radiotherapy (ART) to help create and adjust the treatment plan based on what can be seen inside the body on the pre-existing diagnostic images so that it targets the right spot.

The research study team has developed an institutional celiac plexus auto-planning template using a commercial CT-guided ART platform. The team has looked back at past cases and confirmed that this workflow can safely create treatment plans in a short amount of time. The adaptive radiotherapy that is used in this simulation-free workflow is a a standard-of-care practice for other disease sites. There have been previous research studies that show that it works to lessen the time to treatment when treating other areas of the body (7-9).

The novel approach in this study is the workflow, and as such, the purpose of this study is to demonstrate the feasibility and safety of a simulation-free workflow for celiac plexus SBRT using online adaptive radiotherapy.

03

Conditions studied

  • Pancreatic Cancer
  • Retroperitoneal Pain Syndrome

Keywords

  • Abdominal pain
  • Stereotactic Body Radiotherapy
  • Celiac pain
  • Celiac plexus pain ablation
  • SBRT
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants must have or cytologically confirmed cancer that is 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: 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 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

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 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (estimated)

Study arms

  • Experimental
    Simulation-free treatment delivery of celiac plexus SBRT

    Other: Simulation-free workflow · Radiation: Celiac plexus SBRT

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.

06

What researchers measure

Primary outcomes

  1. Feasibility of the simulation-free adaptive radiotherapy workflow, as measured by rate of successful completion of treatment

    Successful completion is defined as completion of the simulation-free ART workflow through treatment delivery in the first on-table treatment attempt for at least 80% of participants with simulation-free plans meeting dosimetric requirements.

    Time frame: At treatment visit, 1.5 hours

  2. Feasibility of the simulation-free adaptive radiotherapy workflow, as measured by rate of compliance with priority level 1 dose constraints

    Compliance with priority level 1 dose constraints is defined as having a pre-treatment quality assurance clinical gamma passing index less than or equal to 2%/ 2mm.

    Time frame: At treatment visit, 1.5 hours

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Molnar I, Hegyi G, Zsom L, Saahs C, Vagedes J, Kapocs G, Kovacs Z, Sterner MG, Szoke H. Celiac plexus block increases quality of life in patients with pancreatic cancer. J Pain Res. 2019 Jan 14;12:307-315. doi: 10.2147/JPR.S186659. eCollection 2019. PubMed 30679920 ↗
  • Hammer L, Hausner D, Ben-Ayun M, Shacham-Shmueli E, Morag O, Margalit O, Boursi B, Yarom N, Jacobson G, Katzman T, Abrams R, Dicker A, Golan T, Symon Z, Lawrence YR. Single-Fraction Celiac Plexus Radiosurgery: A Preliminary Proof-of-Concept Phase 2 Clinical Trial. Int J Radiat Oncol Biol Phys. 2022 Jul 1;113(3):588-593. doi: 10.1016/j.ijrobp.2022.02.038. Epub 2022 Mar 4. PubMed 35257800 ↗
  • Jacobson G, Fluss R, Dany-BenShushan A, Golan T, Meron T, Zimmermann C, Dawson LA, Barry A, Miszczyk M, Buckstein M, Diaz Pardo D, Aguiar A, Hammer L, Dicker AP, Ben-Ailan M, Morag O, Hausner D, Symon Z, Lawrence YR. Coeliac plexus radiosurgery for pain management in patients with advanced cancer : study protocol for a phase II clinical trial. BMJ Open. 2022 Mar 24;12(3):e050169. doi: 10.1136/bmjopen-2021-050169. PubMed 35332036 ↗
  • Lawrence YR, Miszczyk M, Barry AS, Diaz Pardo DA, Aguiar A, Limon D, et al. Celiac plexus radiosurgery for pain management in advanced cancer: An international phase II trial, health-related quality of life (HRQOL) outcomes. American Society of Clinical Oncology; 2023.
  • Lo SS, Fakiris AJ, Chang EL, Mayr NA, Wang JZ, Papiez L, Teh BS, McGarry RC, Cardenes HR, Timmerman RD. Stereotactic body radiation therapy: a novel treatment modality. Nat Rev Clin Oncol. 2010 Jan;7(1):44-54. doi: 10.1038/nrclinonc.2009.188. Epub 2009 Dec 8. PubMed 19997074 ↗
  • Schuler T, Back M, Hruby G, Carroll S, Jayamanne D, Kneebone A, Stevens M, Lamoury G, Morgia M, Wong S, Grimberg K, Roderick S, Booth J, Eade T. Introducing Computed Tomography Simulation-Free and Electronic Patient-Reported Outcomes-Monitored Palliative Radiation Therapy into Routine Care: Clinical Outcomes and Implementation Experience. Adv Radiat Oncol. 2020 Dec 3;6(2):100632. doi: 10.1016/j.adro.2020.100632. eCollection 2021 Mar-Apr. PubMed 33851063 ↗
  • Wong S, Roderick S, Kejda A, Atyeo J, Grimberg K, Porter B, Booth J, Hruby G, Eade T. Diagnostic Computed Tomography Enabled Planning for Palliative Radiation Therapy: Removing the Need for a Planning Computed Tomography Scan. Pract Radiat Oncol. 2021 Mar-Apr;11(2):e146-e153. doi: 10.1016/j.prro.2020.10.010. Epub 2020 Nov 10. PubMed 33186781 ↗
  • Schiff JP, Zhao T, Huang Y, Sun B, Hugo GD, Spraker MB, Abraham CD. Simulation-Free Radiation Therapy: An Emerging Form of Treatment Planning to Expedite Plan Generation for Patients Receiving Palliative Radiation Therapy. Adv Radiat Oncol. 2022 Oct 3;8(1):101091. doi: 10.1016/j.adro.2022.101091. eCollection 2023 Jan-Feb. PubMed 36304132 ↗
  • Nelissen KJ, Versteijne E, Senan S, Rijksen B, Admiraal M, Visser J, Barink S, de la Fuente AL, Hoffmans D, Slotman BJ, Verbakel WFAR. Same-day adaptive palliative radiotherapy without prior CT simulation: Early outcomes in the FAST-METS study. Radiother Oncol. 2023 May;182:109538. doi: 10.1016/j.radonc.2023.109538. Epub 2023 Feb 16. PubMed 36806603 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Feb 2027, 9 months after the start.

Of 208 non-industry phase 1 interventional studies under Pancreatic Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 74. This study's planned 9 months is below that.

Counting every sponsor, half of 379 studies reached it within 45 months; a quarter within 32 and three quarters within 67.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 5, 2025
First posted
Aug 12, 2025
StartActual
May 12, 2026
Primary completionEst.
Feb 2027
CompletionEst.
Feb 2027
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07117032
Responsible party
Sponsor
First posted
Aug 12, 2025
Start date
May 12, 2026
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Sep 22, 2026

Study contacts

Lauren Henke, MD, MSCI
Contact
lauren.henke@uhhospitals.org
(218) 234 -6429
Lauren Henke, MD, MSCI
principal investigator · Case Comprehensive Cancer Center, University Hospitals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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