Simulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy in Patients With Cancer-Related Celiac Pain

NCT07636382 | Recruiting

• 1 other identifier: 25-5377
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Advanced Cancer; Pancreatic Cancer

Keywords

SBRT; Celiac; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (13)

• Component time

  1 year

• Dosimetric comparison of radiation plans

  1 year

• Frequency of online re-adaptation

  1 Year

• Patient satisfaction

  1 year

• Change in the Brief Pain Inventory pain scale

  6 Weeks

Study Arms (1)

Sim-free ART workflow

EXPERIMENTAL

Other: Treatment plan

Interventions

Treatment plan OTHER

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.

Sim-free ART workflow

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Celiac Disease

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Michael Yan

CONTACT

(416) 946-2320; michael.yan@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

CA (1)