首页 | 本学科首页   官方微博 | 高级检索  
     


A Phase II Study of Biodegradable Stents Plus Palliative Radiotherapy in Oesophageal Cancer
Authors:T. Maishman  H. Sheikh  P. Boger  J. Kelly  K. Cozens  A. Bateman  S. Davies  M. Fay  D. Sharland  A. Jackson
Affiliation:1. Southampton Clinical Trials Unit, University of Southampton, Southampton, UK;2. The Christie NHS Foundation Trust, Manchester, UK;3. University Hospital Southampton NHS Foundation Trust, Southampton, UK;1. Department of Radiation Oncology, Hospital Sírio-Libanês, São Paulo, Brazil;2. Department of Radiation Oncology, Donald Gordon Medical Centre, Johannesburg, South Africa;3. Breast Cancer Radiation Unit, Radiation Oncology Institute, Sheba Medical Center, Ramat Gan, Israel;4. Department of Radiotherapy, Royal Marsden NHS Foundation Trust, London, UK;5. Institute of Cancer Research, London, UK;7. Department of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA;11. Division of Radiation Oncology, McGill University Health Centre, Montréal, Quebec, Canada;12. Department of Radiation Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain;8. Department of Radiation Oncology, Genesis Cancer Care, Wembley, WA, Australia;9. Department of Radiation Oncology, Dalhousie University, Halifax, Nova Scotia, Canada;71. Department of Radiation Oncology, Koo Foundation Sun Yat-Sen Cancer Center, Taipei, Taiwan;112. Department of Oncology, Aarhus University Hospital, Aarhus, Denmark;123. Department of Experimental Clinical Oncology, Aarhus University Hospital, Aarhus, Denmark;84. Radiation Oncology Unit, Oncology Department, Azienda Ospedaliero Universitaria Careggi, Florence, Italy;95. Department of Biomedical, Experimental, and Clinical Sciences "M. Serio", University of Florence, Florence, Italy;77. University of Antwerp, Faculty of Medicine and Health Sciences, Wilrijk-Antwerp, Belgium;1. Radiotherapy Department, University College London Hospital NHS Foundation Trust, London, UK;2. Radiotherapy Physics, University College London Hospital NHS Foundation Trust, London, UK;3. Department of Medical Physics and Bioengineering, University College London, London, UK;1. Radiotherapy Department, Mount Vernon Cancer Centre, Northwood, UK;2. Radiotherapy Department, Leeds Cancer Centre, Leeds, UK;3. Radiotherapy Department, University College London Hospital, London, UK;4. Radiotherapy Department, Oxford Cancer Centre, Oxford, UK;1. Department of Radiation Oncology, Washington University School of Medicine, St. Louis, Missouri, USA;2. Siteman Cancer Center, Washington University School of Medicine, St. Louis, Missouri, USA;3. Division of Nuclear Medicine, Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, Missouri, USA;4. Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Washington University School of Medicine, St. Louis, Missouri, USA;1. Department of Clinical Oncology, Leeds Cancer Centre, Leeds, UK;2. Leeds Institute of Medical Research at St James''s, University of Leeds, UK
Abstract:AimsSelf-expanding metal stents provide rapid improvement of dysphagia in oesophageal cancer but are associated with complications. The aim of the present study was to test the effectiveness of an alternative treatment of combining biodegradable stents with radiotherapy.Materials and methodsA Simon two-stage single-arm prospective phase II trial design was used to determine the efficacy of biodegradable stents plus radiotherapy in patients with dysphagia caused by oesophagus cancer who were unsuitable for radical treatment. Fourteen patients were recruited and data from 12 were included in the final analyses.ResultsFive of 12 patients met the primary end point: one stent-related patient death; four further interventions for dysphagia within 16 weeks of stenting (41.7%, 95% confidence interval 15.2–72.3%). The median time to a 10-point deterioration of quality of life was 2.7 weeks. Nine patients died within 52 weeks of registration. The median time to death from any cause was 15.0 weeks (95% confidence interval 9.6–not reached).ConclusionThe high re-intervention observed, which met the pre-defined early stopping criteria, meant that the suggested alternative treatment was not sufficiently effective to be considered for a larger scale trial design. Further work is needed to define the place of biodegradable stents in the management of malignant oesophageal strictures.
Keywords:Biodegradable stent  dysphagia  oesophageal cancer  palliative treatment  radiotherapy  SEMS
本文献已被 ScienceDirect 等数据库收录!
设为首页 | 免责声明 | 关于勤云 | 加入收藏

Copyright©北京勤云科技发展有限公司  京ICP备09084417号