Celiac Plexus Radio-Surgery for Pain Management

NCT03323489 | Completed DMC FDA Device

• 1 other identifier: SHEBA-17-4292-YL-CTIL
• Study Type: interventional
• Target: 125
• Locations: 4 countries
• Sites: 7

Brief 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.

Conditions

Advanced Cancer; Pancreas Cancer; Pain

Keywords

celiac; radiosurgery; sbrt; radiotherapy; pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain level from baseline - as measured using BPI

  complete or partial pain response as assessed with the BPI scale

  three weeks

Secondary Outcomes (5)

• Average Pain Level

  3 weeks and 6 weeks

• Opioid use

  3 weeks and 6 weeks

• Quality of Life as measured using FACT-Hep questionnaire

  3 weeks and 6 weeks

• six minute walk

  3 weeks and 6 weeks

• hand grip strength

  3 weeks and 6 weeks

Study Arms (1)

celiac radiosurgery, single fraction

EXPERIMENTAL

Celiac Plexus Radiosurgery

Radiation: Celiac Plexus Radiosurgery

Interventions

Celiac Plexus Radiosurgery RADIATION

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

celiac radiosurgery, single fraction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A section 24).
• Patients must have a malignancy that is metastatic or unresectable (for surgical or medical reasons).
• Typical retroperitoneal pain syndrome (pain that radiates from the lower back to the upper abdomen, belt like distribution).
• Uncontrolled pain at recruitment, defined as \>=5 on 11 point BPI scale despite analgesic use.
• Anatomical involvement of the celiac plexus, as defined by at least one of the following:
• Any Pancreatic cancer
• Any other cancer that on imaging demonstrates either: gross involvement of the celiac blood vessels or celiac plexus on imaging OR haziness around the celiac blood vessels, that typically implies tumor engulfment.
• Recent abdominal imaging (CT, PET or MRI) should be at most 2 months old. The CT simulation performed as part of the protocol will be considered sufficient.
• Prior chemotherapy or biological treatment is allowed, but any active oncological treatment should be stopped at least 6 days prior to radiation and renewed at least 6 days following radiation. For trastuzumab emtansine a 14 break prior to, and a 6 day break post-therapy is required. Hormonal treatments (e.g. tamoxifen, androgen ablation, androgen antagonists, aromatase inhibitors), and bone-strengthening agents (e.g. bisphosphonates, anti-RANKL antibody denosumab) may be continued during the radiation treatment, and do not need to be interrupted.
• Willingness to attend 3- and 6- week follow-up visits, and participate in telephone follow-up thereafter.
• Radiation is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of therapy.
• Ability to understand and the willingness to sign a written informed consent document.
• Before patient registration, written informed consent must be provided.

You may not qualify if:

• Patients under 18 years of age
• Patients who are well balanced in terms of pain control
• Patients with life expectancy \<8 weeks as defined by the primary oncologist.
• Known serum albumin \<2.4 (does not need to be especially tested if unknown).\*
• Known lymphopenia defined as \<12% of white blood count (does not need to be especially tested if unknown).\*
• Altered mental status (defined as change in brain function from baseline including confusion, drowsiness, delirium, dementia or coma)\*
• Leptomeningeal spread\*
• Current or previous spinal cord compression\*
• Significant comorbidities (this is left to physicians' discretion. Guidance provided below section 8.4. As an example, patients with metastatic cancer, in the context of combined impaired renal and hepatic function are expected to have a poor survival)\*
• Patients with ECOG Performance status 3 or 4\*
• Any concurrent chemotherapy or biologic treatment is prohibited during 1 week before until 1 week following radiotherapy.
• Previous radiotherapy to upper abdomen.
• Conditions associated with increased side effects to radiotherapy (Inflammatory bowel disease, scleroderma for example).
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Special populations: pregnant women, prisoners, patients with major psychiatric illnesses.

Sponsors & Collaborators

• Dr. Yaacov Lawrence: lead

Study Sites (7)

The Mount Sinai Hospital

New York, New York, 10029-6574, United States

Location

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Princess Maragret Cancer Center

Toronto, Ontario, M5G 2C1, Canada

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Assuta Hospital in Ramat HaHayal

Tel Aviv, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Instituto Português de Oncologia do Porto Francisco Gentil

Porto, 4200-072, Portugal

Location

Related Publications (2)

• Lawrence YR, Miszczyk M, Dawson LA, Diaz Pardo DA, Aguiar A, Limon D, Pfeffer RM, Buckstein M, Barry AS, Meron T, Dicker AP, Wydmanski J, Zimmermann C, Margalit O, Hausner D, Morag O, Golan T, Jacobson G, Dubinski S, Stanescu T, Fluss R, Freedman LS, Ben-Ayun M, Symon Z. Celiac plexus radiosurgery for pain management in advanced cancer: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2024 Aug;25(8):1070-1079. doi: 10.1016/S1470-2045(24)00223-7. Epub 2024 Jul 16.

  PMID: 39029483 DERIVED

• Jacobson G, Fluss R, Dany-BenShushan A, Golan T, Meron T, Zimmermann C, Dawson LA, Barry A, Miszczyk M, Buckstein M, Diaz Pardo D, Aguiar A, Hammer L, Dicker AP, Ben-Ailan M, Morag O, Hausner D, Symon Z, Lawrence YR. Coeliac plexus radiosurgery for pain management in patients with advanced cancer : study protocol for a phase II clinical trial. BMJ Open. 2022 Mar 24;12(3):e050169. doi: 10.1136/bmjopen-2021-050169.

  PMID: 35332036 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Pain; Celiac Disease

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Chair, and Director, Center for Translational Research in Radiation Oncology Dep. Radiation Oncology

Model Details: all of the patients will be treated.

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 27, 2017
• Study Start: January 1, 2018
• Primary Completion: January 30, 2022
• Study Completion: May 1, 2022
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1); IL (3); PT (1)