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

AbstractPURPOSE:
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.
METHODS:
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.
RESULTS:
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.
CONCLUSION:
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.
Topics
  • 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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