Celiac Plexus Radio-Surgery for Pain Management
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|ClinicalTrials.gov Identifier: NCT03323489|
Recruitment Status : Recruiting
First Posted : October 27, 2017
Last Update Posted : January 23, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer Pancreas Cancer Pain||Radiation: Celiac Plexus Radiosurgery||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||all of the patients will be treated.|
|Masking:||None (Open Label)|
|Official Title:||Celiac Plexus Radio-Surgery for Pain Management in Advanced Cancer Patients - a Phase II Trial|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||November 30, 2020|
|Estimated Study Completion Date :||November 30, 2022|
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
- Pain [ Time Frame: three weeks ]complete or partial pain response as assessed with the BPI scale
- Average Pain Level [ Time Frame: 3 weeks and 6 weeks ]Patient reported average pain as assessed with the BPI scale (0 to 10)
- Opioid use [ Time Frame: 3 weeks and 6 weeks ]daily opioid usage
- Quality of Life [ Time Frame: 3 weeks and 6 weeks ]as measured using FACT-Hep scale
- six minute walk [ Time Frame: 3 weeks and 6 weeks ]assess how far patient can walk in 6 minutes, a measure of functionality
- hand grip strength [ Time Frame: 3 weeks and 6 weeks ]measure with hand dynamometer, a measure of functionality
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323489
|Contact: yaacov lawrence, MRCPfirstname.lastname@example.org|
|Contact: tamar email@example.com|
|United States, New York|
|The Mount Sinai Hospital||Recruiting|
|New York, New York, United States, 10029-6574|
|Contact: Michael Buckstein, MD PhD Michael.firstname.lastname@example.org|
|Contact: Lynda Rath email@example.com|
|United States, Ohio|
|The Ohio State University Comprehensive Cancer Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Dayssy Diaz Pardo, MD Dayssy.DiazPardo@osumc.edu|
|Princess Maragret Cancer Center||Recruiting|
|Toronto, Ontario, Canada, M5G 2C1|
|Contact: Barry Aisling, MD firstname.lastname@example.org|
|Contact: Laura Dawson, MD Laura.Dawson@rmp.uhn.ca|
|Sheba Medical Center||Recruiting|
|Ramat Gan, Israel|
|Contact: Yaacov Lawrence, MRCP 9725304410 email@example.com|
|Contact: Amira Dany-BenShushan, MS firstname.lastname@example.org|
|Assuta Hospital in Ramat HaHayal||Recruiting|
|Tel Aviv, Israel|
|Contact: Raphael Pfeffer, MD email@example.com|
|Contact: Hava, BA firstname.lastname@example.org|
|Tel Aviv Sourasky Medical Center||Recruiting|
|Tel Aviv, Israel|
|Contact: Dror Limon email@example.com|
|Instituto Português de Oncologia do Porto Francisco Gentil||Recruiting|
|Porto, Portugal, 4200-072|
|Contact: Artur Aguiar, MD firstname.lastname@example.org|