gms | German Medical Science

27. Deutscher Krebskongress

Deutsche Krebsgesellschaft e. V.

22. - 26.03.2006, Berlin

Quality assurance in clinical trials: centralized radiation oncological review of computed tomography of patients with Hodgkin’s lymphoma

Meeting Abstract

  • corresponding author presenting/speaker Hans Theodor Eich - Universität zu Köln, Klinik für Strahlentherapie, Deutschland
  • Rolf-Peter Müller - Universität zu Köln, Klinik für Strahlentherapie
  • Katja Hansemann - Universität zu Köln, Klinik für Strahlentherapie
  • Susanne Staar - Klinikum Bremen Mitte, Klinik für Strahlentherapie
  • Axel Gossmann - Universität zu Köln, Institut für Röntgendiagnostik
  • Andreas Engert - Universität zu Köln, Klinik I für Innere Medizin
  • Volker Diehl - Universität zu Köln, Klinik I für Innere Medizin

27. Deutscher Krebskongress. Berlin, 22.-26.03.2006. Düsseldorf, Köln: German Medical Science; 2006. DocPO382

Die elektronische Version dieses Artikels ist vollständig und ist verfügbar unter: http://www.egms.de/de/meetings/dkk2006/06dkk492.shtml

Veröffentlicht: 20. März 2006

© 2006 Eich et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielf&aauml;ltigt, verbreitet und &oauml;ffentlich zug&aauml;nglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

Text

Purpose: To guarantee the treatment quality of IF-RT of pts in the HD10 and HD11 trials of the GHSG with 460 participating study centers, a quality assurance program (QAP) was conducted. It was based on a central prospective radiation oncological review of all pts diagnostic imaging and clinical findings. The purpose was to assess the feasibility of such a procedure, its impact on the final definition of disease extension and on pts management.

Materials: Between 1998-2002, 1371 pts were enrolled into the HD10 and 1570 pts into the HD11. All study centers were required to score disease involvement at a total of 34 possible sites on case report forms (CRF) and sent them together with all diagnostic imaging to the RT reference center. Here, the images were reviewed and compared with the CRF. Complete sets of documentation of 89% of pts both in HD10 and HD11 were submitted to the reference center.

Results: The evaluation of the QAP showed that a considerable proportion of involved sites, were not or incorrect recorded on the CRF. For pts in HD10 there was a correction of the disease involvement in 49%, for pts in HD11 in 67%. This resulted in a change of disease stage in 40/1529 pts whose documented disease involvement had to be corrected. 93/1529 pts had to be treated in a different protocol, due to changes of stage and risk factors. Due to the incorrect lymph node documentation the RT treatment volume had to be enlarged in 891/1529 pts and reduced in 82/1529 pts.

Conclusion: A central prospective review of pts data and consecutive prescription of individual RT treatment volume is feasible within large multicenter trials. Such a procedure has a significant impact on the correctness of stage definition, allocation to treatment groups and extension of the IF treatment volume.