5 Participants NeededMy employer runs this trial

Stereotactic Body Radiotherapy for Cancer-Related Celiac Pain

(Celiac SRS Trial)

MY
Overseen ByMichael Yan
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Health Network, Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults (over 18) with severe pain from cancer involving the celiac plexus, such as pancreatic cancer that can't be removed or has spread. Participants must have clear imaging showing involvement of the celiac area and a pain score of at least 5 out of 10. They need to pause other active cancer treatments around the time of this therapy.

Inclusion Criteria

I am older than 18 years.
My cancer involves the celiac plexus area near the main abdominal blood vessels.
I have stopped my cancer treatment at least 1 week before radiation and will wait 1 week after.
See 5 more

Exclusion Criteria

I cannot lie on my back and stay still for 45 minutes.
I am completely disabled and unable to care for myself.
I do not have conditions like inflammatory bowel disease or scleroderma.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a single-session celiac plexus SBRT using a simulation-free adaptive radiotherapy workflow

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of pain scale and medication use

6 weeks
2 visits (in-person)

Long-term Follow-up

Participants are monitored for additional outcomes such as patient satisfaction and dosimetric comparisons

1 year

What Are the Treatments Tested in This Trial?

Trial Overview

The study tests a new way to deliver standard celiac plexus radiotherapy in one session without prior simulation scans, using adaptive planning on the treatment day. It aims to see if this faster workflow is safe and practical for patients with severe cancer-related abdominal pain.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Sim-free ART workflowExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+