Single-session celiac plexus SBRT using a simulation-free adaptive workflow for cancer-related pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm pilot study assessing the feasibility and safety of a simulation-free adaptive radiotherapy workflow for celiac plexus SBRT, delivering treatment in a single session using pre-existing imaging and on-the-day plan adaptation. The standard SBRT treatment is not new, but the workflow is designed to compress planning and delivery into one visit. The study aims for at least 80% completion of the on-table treatment attempt without requiring a separate CT simulation. Eligible patients have metastatic or unresectable cancer with celiac plexus involvement and significant retroperitoneal pain. Outcomes focus on feasibility, safety, and preliminary pain relief signals in adult participants.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Princess Margaret Cancer Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Michael Yan
• Email: michael.yan@uhn.ca
• Phone: (416) 946-2320

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.