Neuropediatrics 2008; 39 - P085
DOI: 10.1055/s-0029-1215854

Randomized multicenter trial on patients wit childhood craniopharyngioma (KRANIOPHARYNGEOM 2007) – Update after 12 months of recruitment

U Gebhardt 1, S Schröder 1, F Pohl 2, RD Kortmann 3, I Zwiener 4, A Faldum 4, M Warmuth-Metz 5, T Pietsch 6, G Calaminus 7, R Kolb 1, C Wiegand 8, N Sörensen 8, HL Müller 1
  • 1Zentrum für Kinder- und Jugendmedizin, Klinikum Oldenburg gGmbH, Klinik für Allgemeine Kinderheilkunde, Hämatologie/Onkologie, Oldenburg, Germany
  • 2Universitätsklinikum Regensburg, Klinik für Strahlentherapie, Regensburg, Germany
  • 3Universitätsklinikum Leipzig, Klinik für Radioonkologie, Leipzig, Germany
  • 4Institut für Medizinische Biostatistik, Epidemiologie und Informatik, Universität Mainz, Mainz, Germany
  • 5Universitätsklinikum Würzburg, Abteilung für Neuroradiologie, Würzburg, Germany
  • 6Institut für Neuropathologie, Universitätsklinikum Bonn, Bonn, Germany
  • 7Universitätsklinikum Münster, Klinik für Päfdiatrische Onkologie, Münster, Germany
  • 8Neurochirurgische Klinik, Evangelisches Krankenhaus, Oldenburg, Germany

Despite high overall survival rates (92%) in patients with childhood craniopharyngioma (CP), health-related quality of life (QoL) is frequently impaired due to sequelae resulting from hypothalamic involvement of CP such as severe obesity. Based on the results of KRANIOPHARYNGEOM 2000 radical surgery is no appropriate treatment strategy in patients with hypothalamic involvement of CP. Furthermore, tumour progression and relapses are frequent and early events in CP patients. The analysis of event-free survival rates (EFS) in 117 prospectively evaluated patients with CP showed a high rate of early events in terms of tumour progression after incomplete resection (EFS: 0.31±0.07) and relapses after complete resection (EFS: 0.63±0.09) during the first three years of follow-up. Therefore, innovative treatment strategies are warranted for patients with hypothalamic involvement of CP after incomplete resection.

Accordingly, in KRANIOPHARYNGEOM 2007 QoL, and survival rates in CP pts are analyzed after randomization of the time point of irradiation (XRT) after incomplete resection (immediate XRT versus XRT at progression of residual tumour). Up to now (11/08) 27 pts with CP were recruited in KRANIOPHARYNGEOM 2007 (15 pts in the randomization arm; 6 pts in the surveillance arm; 6 pts in the process of review of imaging). 5 of 15 pts were randomized. 10 pts could not be randomized due to parental decision (3 pts), insufficient organization (4 pts) and due to decision of the physician (3 pts).

In conclusion, KRANIOPHARYNGEOM 2007 represents the first randomized trial in patients with CP and the first study in children and adolescents with a CNS tumour analyzing health-related QoL as an endpoint. Aim of the study is to analyze the appropriate time point of XRT after incomplete resection in order to improve QoL in patients with hypothalamic involvement. The recruitment rate is high. However, the compliance to randomization has to be improved. Problems in the organization and timing of the randomization process have been improved during the first year of recruitment.