Clinical trial · Interventional
Celiac Plexus Radiosurgery for Pain Management
Celiac Plexus Radiosurgery for Pain Management in Advanced Cancer Patients - a Phase II Trial
NCT02356406CI-TRIAL-00016803unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective study evaluates celiac plexus radiosurgery for pain control in patients with upper abdominal malignancies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Digestive System Neoplasms | Digestive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celiac Plexus Radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Celiac Plexus Radiosurgery
- description
- The study has a prospective, single arm design. It will be composed from an initial run-in safety assessment that will include 6 patients and then continue as a phase II trial. All eligible patients will receive the same protocol of celiac plexus radiosurgery
- interventionNames
- Radiation: Celiac Plexus Radiosurgery
Primary outcomes (1)
- measure
- Numerical Rating Scale (NRS) pain score difference from baseline
- timeFrame
- 3 weeks post treatment
Secondary outcomes (4)
- measure
- Numerical Rating Scale (NRS) pain score difference from baseline
- timeFrame
- 6 weeks and 3 months post treatment and subsequently every 3 months on average up to 1 year post treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with upper abdominal cancer (pancreatic/gastric/colon/hepato-biliary cancer) with typical retroperitoneal pain syndrome (somatic pain that radiates from the upper abdomen to the back) thought to be secondary to celiac plexus involvement, directly or indirectly, and have high level of pain despite opioids usage (NRS \>4). Patients with other cancer types metastatic to the celiac lymph nodes will also be eligible * Recent abdominal imaging (CT, PET or MRI) should be at most 2 months old. * Prior chemotherapy or biological treatment is allowed, but any active oncological treatment should be stopped at least 1 week prior to radiation and renewed at least 1 week following radiation. Following gemcitabine 2 weeks are required between final dose and commencement of radiation * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial Exclusion Criteria: * Patients under 18 years of age * Patients who are well balanced in terms of pain control * Patients with life expectancy \<8 weeks * Patients with ECOG (Eastern cooperative oncology group) performance status 4 * Any concurrent chemotherapy or biologic treatment is prohibited during 1 week before until 1 week following radiotherapy * Special populations: pregnant women, prisoners, patients with major psychiatric illnesses * Previous radiotherapy to upper abdomen * Conditions associated with increased side effects to radiotherapy (IBD (inflammatory bowel disease) for example)
References
Publications (13)
- BACKGROUNDLevy MJ, Wiersema MJ. EUS-guided celiac plexus neurolysis and celiac plexus block. Gastrointest Endosc. 2003 Jun;57(7):923-30. doi: 10.1016/s0016-5107(03)70036-4. No abstract available. PMID 12776048
- BACKGROUNDKambadakone A, Thabet A, Gervais DA, Mueller PR, Arellano RS. CT-guided celiac plexus neurolysis: a review of anatomy, indications, technique, and tips for successful treatment. Radiographics. 2011 Oct;31(6):1599-621. doi: 10.1148/rg.316115526. PMID 21997984
- BACKGROUNDZhu Z, Friess H, diMola FF, Zimmermann A, Graber HU, Korc M, Buchler MW. Nerve growth factor expression correlates with perineural invasion and pain in human pancreatic cancer. J Clin Oncol. 1999 Aug;17(8):2419-28. doi: 10.1200/JCO.1999.17.8.2419. PMID 10561305
- BACKGROUNDWong GY, Schroeder DR, Carns PE, Wilson JL, Martin DP, Kinney MO, Mantilla CB, Warner DO. Effect of neurolytic celiac plexus block on pain relief, quality of life, and survival in patients with unresectable pancreatic cancer: a randomized controlled trial. JAMA. 2004 Mar 3;291(9):1092-9. doi: 10.1001/jama.291.9.1092. PMID 14996778
- BACKGROUNDSmigielski J, Piskorz L, Wawrzycki M, Kutwin L, Misiak P, Brocki M. Assessment of quality of life in patients with non-operated pancreatic cancer after videothoracoscopic splanchnicectomy. Wideochir Inne Tech Maloinwazyjne. 2011 Sep;6(3):132-7. doi: 10.5114/wiitm.2011.24690. Epub 2011 Sep 30. PMID 23255971
- BACKGROUNDDidolkar MS, Coleman CW, Brenner MJ, Chu KU, Olexa N, Stanwyck E, Yu A, Neerchal N, Rabinowitz S. Image-guided stereotactic radiosurgery for locally advanced pancreatic adenocarcinoma results of first 85 patients. J Gastrointest Surg. 2010 Oct;14(10):1547-59. doi: 10.1007/s11605-010-1323-7. Epub 2010 Sep 14. PMID 20839073
- BACKGROUNDRwigema JC, Parikh SD, Heron DE, Howell M, Zeh H, Moser AJ, Bahary N, Quinn A, Burton SA. Stereotactic body radiotherapy in the treatment of advanced adenocarcinoma of the pancreas. Am J Clin Oncol. 2011 Feb;34(1):63-9. doi: 10.1097/COC.0b013e3181d270b4.