Palliative brachytherapy with or without primary stent placement in patients with oesophageal cancer, a randomised phase III trial.

To investigate whether a combination of self-expanding metal stent (SEMS) and brachytherapy provided more rapid and prolonged effect on dysphagia without increased pain compared to brachytherapy alone in patients with incurable oesophageal cancer.
41 Patients were randomised to SEMS followed by brachytherapy, 8 Gy×3 (n=21) or brachytherapy alone, 8 Gy×3 (n=20). Change in dysphagia and pain three and seven weeks after randomisation (FU1 and FU2) was assessed by patient-reported outcome. Dysphagia, other symptoms and health-related quality of life were assessed every four weeks thereafter. The study was closed before the estimated patient-number was reached due to slow recruitment.
Patients receiving SEMS followed by brachytherapy had significantly improved dysphagia at FU1 compared to patients receiving brachytherapy alone (n=35). Difference in pain was not observed. At FU2, patients in both arms (n=21) had less dysphagia. Four patients in the combined treatment arm experienced manageable complications, no complications occurred after brachytherapy alone.
For the relief of dysphagia, SEMS followed by brachytherapy is preferable and safe for patients in need of immediate alleviation, while brachytherapy with or without preceding SEMS provides relief within a few weeks after treatment.
AuthorsCecilie Delphin Amdal, Anne-Birgitte Jacobsen, Berit Sandstad, Trond Warloe, Kristin Bjordal
JournalRadiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology (Radiother Oncol) Vol. 107 Issue 3 Pg. 428-33 (Jun 2013) ISSN: 1879-0887 [Electronic] Ireland
PMID23647761 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2013 Elsevier Ireland Ltd. All rights reserved.
  • Aged
  • Aged, 80 and over
  • Brachytherapy (adverse effects)
  • Deglutition Disorders (etiology)
  • Esophageal Neoplasms (mortality, psychology, radiotherapy)
  • Female
  • Humans
  • Male
  • Middle Aged
  • Palliative Care
  • Quality of Life
  • Stents

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