About 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Treatment plan