[Method for evaluating long term complications. A study from a phase III trial comparing two low dose rates in gynecologic brachytherapy]

Bull Cancer. 1994 Jul;81(7):632-7.
[Article in French]

Abstract

When treatment complications are the main criteria of a study, the simplest way for estimating the complication rate over time is to use the Kaplan-Meier method. The failure is the onset of the first complication. A new way is proposed here which takes into account the time to an eventual second, and third complication, and their duration as well. Results from a phase III randomized trial comparing two preoperative brachytherapy low dose rates in localized stage cervix carcinoma patients are used to illustrate both methods. The new method showed a greater long term complication rate in the higher dose rate group.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • English Abstract
  • Randomized Controlled Trial

MeSH terms

  • Brachytherapy / adverse effects*
  • Cross-Sectional Studies
  • Dose-Response Relationship, Radiation
  • Female
  • Follow-Up Studies
  • Humans
  • Neoplasm Staging
  • Radiation Injuries / etiology*
  • Radiotherapy Dosage
  • Risk Factors
  • Survival Analysis
  • Uterine Cervical Neoplasms / pathology
  • Uterine Cervical Neoplasms / radiotherapy*
  • Uterine Cervical Neoplasms / surgery