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

Radiother Oncol. 2013 Jun;107(3):428-33. doi: 10.1016/j.radonc.2013.04.008. Epub 2013 May 3.


Purpose: 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.

Keywords: Brachytherapy; Dysphagia; Oesophageal neoplasm; Quality of life; Randomised trial; Stent.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Brachytherapy* / adverse effects
  • Deglutition Disorders / etiology
  • Esophageal Neoplasms / mortality
  • Esophageal Neoplasms / psychology
  • Esophageal Neoplasms / radiotherapy*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Palliative Care*
  • Quality of Life
  • Stents*