Pancreatic CancerPhase 1NCT07117032
Simulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy (SBRT) in Participants With Cancer-Related Celiac Pain
A Phase 1 study testing Simulation-free workflow and Celiac plexus SBRT in people with Pancreatic Cancer and Retroperitoneal Pain Syndrome, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Retroperitoneal Pain Syndrome
- What is being tested?
- Simulation-free workflow and Celiac plexus SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2026to Feb 2027
- Phase
- Phase 1
- 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
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Lauren Henke, MD, MSCI, 218-234-6429, lauren.henke@uhhospitals.org
Lauren Henke, MD, MSCI
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
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.
- Conditions
- Pancreatic Cancer, Retroperitoneal Pain Syndrome
- Being tested
- Simulation-free workflow, Celiac plexus SBRT
- Keywords
- Abdominal pain, Stereotactic Body Radiotherapy, Celiac pain, Celiac plexus pain ablation, SBRT
- Medical subject headings
- Pancreatic Neoplasms, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-free workflowOther
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 SBRTRadiation
Participants will receive SBRT per standard of care. This treatment visit will take up to 1.5 hours.
| Study group | Role | What they receive |
|---|---|---|
| Simulation-free treatment delivery of celiac plexus SBRT | Experimental | Not described Receives: Other: Simulation-free workflow; Radiation: Celiac plexus SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: At treatment visit, 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start12 May 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren Henke, MD, MSCI, Principal investigator, Case Comprehensive Cancer Center, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117032
- Sponsor's protocol ID
- CASE5225
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 30679920Hammer 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 35257800Jacobson 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 35332036Lawrence 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 19997074Schuler 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 33851063Wong 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 33186781Schiff 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 36304132Nelissen 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 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
- NCT07117032
- Acronym / sponsor ID
- CASE5225
- Conditions
- Pancreatic Cancer, Retroperitoneal Pain Syndrome
- Keywords
- Abdominal pain, Stereotactic Body Radiotherapy, Celiac pain, Celiac plexus pain ablation, SBRT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 12 May 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 12 Aug 2025 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simulation-free treatment delivery of celiac plexus SBRT | Experimental | Other: Simulation-free workflow, Radiation: Celiac plexus SBRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Simulation-free workflowPre-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. | Other | Simulation-free treatment delivery of celiac plexus SBRT |
| Celiac plexus SBRTParticipants will receive SBRT per standard of care. This treatment visit will take up to 1.5 hours. | Radiation | Simulation-free treatment delivery of celiac plexus SBRT |
Primary outcome
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
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.
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
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.
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 22 Sep 2026.
- Background: PubMed 30679920Molnar 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.
- Background: PubMed 35257800Hammer 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.
- Background: PubMed 35332036Jacobson 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.
- BackgroundLawrence 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.
- Background: PubMed 19997074Lo 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.
- Background: PubMed 33851063Schuler 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.
- Background: PubMed 33186781Wong 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.
- Background: PubMed 36304132Schiff 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.
- Background: PubMed 36806603Nelissen 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.
- Individual participant dataSharing planned: No
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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.
Lauren Henke, MD, MSCI principal investigator
Case Comprehensive Cancer Center, University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Simulation-free workflow and Celiac plexus SBRT in people with Pancreatic Cancer and Retroperitoneal Pain Syndrome, run by Case Comprehensive Cancer Center at 1 site in United States.
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 10 inclusion and 5 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 22 Sep 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Lauren Henke, MD, MSCI ((218) 234 -6429, lauren.henke@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07117032, which also lists 9 linked publications.
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 22 Sep 2026.