Celiac Plexus Radio-Surgery for Pain Management

Summary

Participation Requirements

Description

Severe lower back pain radiating anteriorly in a belt-like distribution is characteristic of pancreatic cancer. The pain is thought related to involvement of the celiac nerve plexus, located behind the pancreas; due to either macroscopic compression or microscopic perineural invasion. Contemporary a...

Severe lower back pain radiating anteriorly in a belt-like distribution is characteristic of pancreatic cancer. The pain is thought related to involvement of the celiac nerve plexus, located behind the pancreas; due to either macroscopic compression or microscopic perineural invasion. Contemporary approaches (narcotic analgesics, celiac nerve blocks and systemic chemotherapy) each have drawbacks, and as a consequence many patients suffer from severe pain. We hypothesized that ablative radiosurgery (high dose, precise X-ray treatment) focused on the celiac plexus would succeed in palliating these patients, possibly by interrupting pain transmission. It is important to emphasize that bringing pain relief to cancer patients is not only humane, but also associated with improved mood, quality of life and possibly improved survival. Our preliminary results suggest that the treatment is both effective and well tolerated; furthermore it appears that the patients tolerate subsequent cytotoxic treatments better. We will perform a prospective phase II multicenter clinical trial to test our hypothesis Compared to the small pilot trial the follow-up trial will: 1) Enroll a larger number of patients (n=100). 2) Be performed across a number of institutions, in both the Middle East and the United States. 3) Include improved measures of quality of life and functional capacity. 'Caregiver burden' and 'Patient hope' will also be assessed. 4) Incorporate exploratory translational endpoints relating to immune activation. Target population Adult patients with severe, poorly controlled lower back/abdominal pain (intensity at least 5/10 on the Numeric Pain Rating Scale) thought to originate in the celiac plexus (generally, but not exclusively, from pancreatic cancer). Patients with a poor prognosis, and those with previous radiation to the upper abdomen will be excluded. Systemic therapies will need to be stopped several days prior to, and following, treatment.

Tracking Information