Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Dr. Yaacov Lawrence|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Canada, Israel, Portugal, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Advanced Cancer, Pancreas Cancer, Pain|
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.
Experimental: celiac radiosurgery, single fraction
Celiac Plexus Radiosurgery
Radiation: - Celiac Plexus Radiosurgery
patients will receive a single radiation treatment of 25 Gy directed towards the celiac surgery, and at the physician's discretion also abutting tumor
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.