Coeliac plexus radiosurgery for pain management in patients with advanced cancer : study protocol for a phase II clinical trial
Introduction Pancreatic cancer is characterised by severe mid-back and epigastric pain caused by tumour invasion of the coeliac nerve plexus. This pain is often poorly managed with standard treatments. This clinical trial investigates a novel approach in which high-dose radiation (radiosurgery) is t...
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BMJ Publishing Group
2022-03-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/3/e050169.full |
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| author | Laura A Dawson Camilla Zimmermann Aisling Barry Galia Jacobson Ronen Fluss Amira Dany-BenShushan Talia Golan Tikva Meron Marcin Miszczyk Michael Buckstein Dayssy Diaz Pardo Artur Aguiar Liat Hammer Adam P Dicker Maoz Ben-Ailan Ofir Morag David Hausner Zvi Symon Yaacov R. Lawrence |
| author_facet | Laura A Dawson Camilla Zimmermann Aisling Barry Galia Jacobson Ronen Fluss Amira Dany-BenShushan Talia Golan Tikva Meron Marcin Miszczyk Michael Buckstein Dayssy Diaz Pardo Artur Aguiar Liat Hammer Adam P Dicker Maoz Ben-Ailan Ofir Morag David Hausner Zvi Symon Yaacov R. Lawrence |
| author_sort | Laura A Dawson |
| collection | DOAJ |
| description | Introduction Pancreatic cancer is characterised by severe mid-back and epigastric pain caused by tumour invasion of the coeliac nerve plexus. This pain is often poorly managed with standard treatments. This clinical trial investigates a novel approach in which high-dose radiation (radiosurgery) is targeted to the retroperitoneal coeliac plexus nerve bundle. Preliminary results from a single institution pilot trial are promising: pain relief is substantial and side effects minimal. The goals of this study are to validate these findings in an international multisetting, and investigate the impact on quality of life and functional status among patients with terminal cancer.Methods and analysis A single-arm prospective phase II clinical trial. Eligible patients are required to have severe coeliac pain of at least five on the 11-point BPI average pain scale and Eastern Cooperative Oncology Group performance status of two or better. Non-pancreatic cancers invading the coeliac plexus are also eligible. The intervention involves irradiating the coeliac plexus using a single fraction of 25 Gy. The primary endpoint is the complete or partial pain response at 3 weeks. Secondary endpoints include pain at 6 weeks, analgesic use, hope, qualitative of life, caregiver burden and functional outcomes, all measured using validated instruments. The protocol is expected to open at a number of cancer centres across the globe, and a quality assurance programme is included. The protocol requires that 90 evaluable patients be accrued, based upon the assumption that a third of patients are non-evaluable (e.g. due to death prior to 3-weeks post-treatment assessment, or spontaneous improvement of pain pre-treatment), it is estimated that a total of 120 patients will need to be accrued. Supported by Gateway for Cancer Research and the Israel Cancer Association.Ethics and dissemination Ethic approval for this study has been obtained at eight academic medical centres located across the Middle East, North America and Europe. Results will be disseminated through conference presentations and peer-reviewed publications.Trial registration number NCT03323489. |
| format | Article |
| id | doaj-art-dbe7bee2a9924507b65a3138dcb82299 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-03-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-dbe7bee2a9924507b65a3138dcb822992025-08-20T02:10:39ZengBMJ Publishing GroupBMJ Open2044-60552022-03-0112310.1136/bmjopen-2021-050169Coeliac plexus radiosurgery for pain management in patients with advanced cancer : study protocol for a phase II clinical trialLaura A Dawson0Camilla Zimmermann1Aisling Barry2Galia Jacobson3Ronen Fluss4Amira Dany-BenShushan5Talia Golan6Tikva Meron7Marcin Miszczyk8Michael Buckstein9Dayssy Diaz Pardo10Artur Aguiar11Liat Hammer12Adam P Dicker13Maoz Ben-Ailan14Ofir Morag15David Hausner16Zvi Symon17Yaacov R. Lawrence18Radiation Oncology, Princess Margaret Hospital Cancer Centre, University of Toronto, Toronto, Ontario, CanadaDepartment of Supportive Care, Princess Margaret Cancer Centre, University Health Network and Department of Medicine, University of Toronto, Toronto, Ontario, CanadaRadiation Oncology, Princess Margaret Hospital Cancer Centre, University of Toronto, Toronto, Ontario, CanadaRadiation Oncology, Sheba Medical Center, Tel Hashomer, Tel Aviv, Israel1 Gertner Institute for Epidemiology and Health Policy Research, Sheba Medical Center, Ramat-Gan, IsraelIsraeli Center for Cardiovascular Research, Sheba Medical Center, Tel Hashomer, Tel Aviv, IsraelOncology, Sheba Medical Center, Tel Hashomer, Tel Aviv, IsraelOncology, Sheba Medical Center, Tel Hashomer, Tel Aviv, IsraelIIIrd Radiotherapy and Chemotherapy Department, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice, PolandDepartment of Radiation Oncology, Icahn School of Medicine at Mount Sinai, New York, New York, USADepartment of Radiation Oncology, The Ohio State University Medical Center, Columbus, Ohio, USARadiation Oncology, Portuguese Institute of Oncology of Porto, Porto, PortugalRadiation Oncology, Sheba Medical Center, Tel Hashomer, Tel Aviv, IsraelRadiation Oncology, Thomas Jefferson University, Philadelphia, Pennsylvania, USARadiation Oncology, Sheba Medical Center, Tel Hashomer, Tel Aviv, IsraelCancer Pain Unit, Institute of Oncology, Sheba Medical Center, Tel Aviv, IsraelTel Aviv University Faculty of Medicine, Tel Aviv, IsraelRadiation Oncology, Sheba Medical Center, Tel Hashomer, Tel Aviv, IsraelRadiation Oncology, Sheba Medical Center, Tel Hashomer, Tel Aviv, IsraelIntroduction Pancreatic cancer is characterised by severe mid-back and epigastric pain caused by tumour invasion of the coeliac nerve plexus. This pain is often poorly managed with standard treatments. This clinical trial investigates a novel approach in which high-dose radiation (radiosurgery) is targeted to the retroperitoneal coeliac plexus nerve bundle. Preliminary results from a single institution pilot trial are promising: pain relief is substantial and side effects minimal. The goals of this study are to validate these findings in an international multisetting, and investigate the impact on quality of life and functional status among patients with terminal cancer.Methods and analysis A single-arm prospective phase II clinical trial. Eligible patients are required to have severe coeliac pain of at least five on the 11-point BPI average pain scale and Eastern Cooperative Oncology Group performance status of two or better. Non-pancreatic cancers invading the coeliac plexus are also eligible. The intervention involves irradiating the coeliac plexus using a single fraction of 25 Gy. The primary endpoint is the complete or partial pain response at 3 weeks. Secondary endpoints include pain at 6 weeks, analgesic use, hope, qualitative of life, caregiver burden and functional outcomes, all measured using validated instruments. The protocol is expected to open at a number of cancer centres across the globe, and a quality assurance programme is included. The protocol requires that 90 evaluable patients be accrued, based upon the assumption that a third of patients are non-evaluable (e.g. due to death prior to 3-weeks post-treatment assessment, or spontaneous improvement of pain pre-treatment), it is estimated that a total of 120 patients will need to be accrued. Supported by Gateway for Cancer Research and the Israel Cancer Association.Ethics and dissemination Ethic approval for this study has been obtained at eight academic medical centres located across the Middle East, North America and Europe. Results will be disseminated through conference presentations and peer-reviewed publications.Trial registration number NCT03323489.https://bmjopen.bmj.com/content/12/3/e050169.full |
| spellingShingle | Laura A Dawson Camilla Zimmermann Aisling Barry Galia Jacobson Ronen Fluss Amira Dany-BenShushan Talia Golan Tikva Meron Marcin Miszczyk Michael Buckstein Dayssy Diaz Pardo Artur Aguiar Liat Hammer Adam P Dicker Maoz Ben-Ailan Ofir Morag David Hausner Zvi Symon Yaacov R. Lawrence Coeliac plexus radiosurgery for pain management in patients with advanced cancer : study protocol for a phase II clinical trial BMJ Open |
| title | Coeliac plexus radiosurgery for pain management in patients with advanced cancer : study protocol for a phase II clinical trial |
| title_full | Coeliac plexus radiosurgery for pain management in patients with advanced cancer : study protocol for a phase II clinical trial |
| title_fullStr | Coeliac plexus radiosurgery for pain management in patients with advanced cancer : study protocol for a phase II clinical trial |
| title_full_unstemmed | Coeliac plexus radiosurgery for pain management in patients with advanced cancer : study protocol for a phase II clinical trial |
| title_short | Coeliac plexus radiosurgery for pain management in patients with advanced cancer : study protocol for a phase II clinical trial |
| title_sort | coeliac plexus radiosurgery for pain management in patients with advanced cancer study protocol for a phase ii clinical trial |
| url | https://bmjopen.bmj.com/content/12/3/e050169.full |
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