CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 125 enrolled
Drug / intervention
Celiac Plexus Radiosurgeryradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03323489
NCT03323489N/ACompleted

Celiac Plexus Radio-Surgery for Pain Management in Advanced Cancer Patients - a Phase II Trial

Dr. Yaacov Lawrence·interventional·Posted Oct 27, 2017·Updated May 12, 2022

In Brief

A clinical study evaluating Celiac Plexus Radiosurgery for Advanced Cancer and 2 related conditions. Completed, enrolled 125 participants across 7 sites in 4 countries.

Detailed Summary

Many cancer patients, especially those with pancreatic cancer, suffer from severe lower back / upper abdominal pain. This pain is often poorly managed with standard treatments; the doses of painkiller required often induce side effects, whereas nerve block procedures (where a needle is deeply inserted into the back) are both invasive and of limited benefit. This clinical trial investigates a unique novel approach in which high-dose radiation (radiosurgery) is focused on the offending nerve bundle (the celiac plexus) in the posterior abdomen. Preliminary results from a single institution pilot trial are very promising: pain relief is substantial and side effects minimal. In this multi-center clinical trial, patients will be accrued and receive treatment at several international locations. Main aim of the study: Establish the safety and efficacy of the treatment in the multi-center setting. This trial will bring pain relief to cancer sufferers and improve current acceptable standard of care. The trial resonates with the Gateway mission of promoting new treatments that directly benefit people living with cancer, enhancing their wellbeing, and consequently decreasing the fear associated with a cancer diagnosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Israel, Portugal, United States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 27, 2017
Enrollment StartJan 1, 2018
Primary CompletionJan 30, 2022
Study CompletionMay 1, 2022
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 8.7 years ago

Interventions

Celiac Plexus Radiosurgeryradiation

patients will receive a single radiation treatment of 25 Gy directed towards the celiac surgery, and at the physician's discretion also abutting tumor