Trial Type: Quality of Life Study
Trial Status: Active Trial

 
Dr Yaacov Lawrence black and white.jpg
 
Dr. Yaacov Lawrence
Sheba Medical Center, Israel

Patients with upper abdominal cancer, especially pancreatic cancer, often suffer from severe back pain in a “belt distribution.” This pain is thought to originate in the celiac plexus -- nerves located behind the pancreas at the level of the 12th thoracic vertebrae. This intense pain is poorly managed by opiate medications and nerve blocks. Patient suffering, coping mechanisms, and caregiver burden are all worsened by the discomfort. New techniques for pain management are urgently needed.

A pilot study to determine if targeting the celiac plexus with a single dose of radiation benefits these patients is almost completed. The researchers are finding that celiac plexus radiosurgery is feasible, well-tolerated and associated with minimal side-effects. Many of the patients have reported considerable decrease in pain intensity and an improved quality of life. Dr. Lawrence and his Tel Aviv team, along with investigators from London, Philadelphia, Ohio and Toronto, are ready to begin a Phase 2 study with an enrollment of 100 subjects..

This single arm study’s primary objectives are to determine if celiac plexus radiosurgery decreases pain in patients with celiac-plexus pain syndrome and to assess the tolerability and side effects. Secondary objectives will assess quality of life, use of analgesics and caregiver burden. Tertiary objectives include defining which subpopulations and which tumors benefit from radiosurgery the most. 

If it is found that a single dose of targeted radiation can greatly reduce the back pain suffered by patients with upper abdominal cancer, it may become a routine part of their cancer treatment.


Clinical Summary:
Patients with upper abdominal cancer, especially pancreatic cancer often suffer from severe back pain in a "belt distribution." This pain is thought to originate in the celiac plexus, located behind the pancreas at the level of the 12th thoracic vertebra. The pain interferes with activities of daily life, reducing patients' quality of life, and may in addition overwhelm patients' coping mechanisms, disrupting interpersonal relationships. Standard treatments include opioid (narcotic) analgesics and a celiac plexus nerve block. Unfortunately, the high doses of opioid analgesics generally required are associated with side effects. The main alternative, a celiac plexus nerve block ( an injection of local anesthetic into and around the celiac plexus nerves), is both invasive, and has limited efficacy. Therefore, in patients with upper abdominal cancer, especially those with pancreatic cancer, new techniques of pain management are urgently needed.

We have developed a new treatment for pain emanating from the celiac plexus. We hypothesize that ablative radiosurgery (high dose, precise X-ray treatment) focused on the celiac plexus will succeed in palliating these patients. Here we propose a prospective Phase ll multi-center clinical trial to test this hypothesis.

Our pilot "proof of concept" clinical study of celiac plexus radiosurgery (NCT02356406) is close to completion. Those accrued were the first patients to ever receive celiac plexus radiosurgery. This study demonstrated that performing celiac plexus radiosurgery is feasible, well tolerated and associated with minimal side effects; furthermore, many patients reported considerable decreases in pain intensity. The overall aim of the proposed trial is to establish celiac plexus radiosurgery as a safe and effective means of reducing pain, and improving quality of life among patients with celiac pain.

 

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