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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Simulation-free workflow

    Other intervention

    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 SBRT

    Radiation

    Participants will receive SBRT per standard of care. This treatment visit will take up to 1.5 hours.

Treatment groups

5 Participants
are divided into 1 treatment group
Group A: Simulation-free treatment delivery of celiac plexus SBRTExperimental treatment 2 interventions

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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