Article
Randomized multicenter trial on patients with childhood craniopharyngioma (KRANIOPHARYNGEOM 2007) – update after 27 months of recruitment
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Published: | September 16, 2010 |
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Objective: Despite high survival rates (92%) in patients with childhood craniopharyngioma (CP), quality of life (QoL) is frequently impaired due to sequelae such as severe obesity resulting from hypothalamic involvement of CP. Based on the results of the multicenter prospective study KRANIOPHARYNGEOM 2000 radical surgery is no appropriate treatment strategy in patients with hypothalamic involvement. Furthermore, tumor progression/relapses are frequent 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 tumor 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.
Methods: Accordingly, in KRANIOPHARYNGEOM 2007 QoL, and survival rates in CP pts (>5yrs at diagnosis) are analyzed after randomization of the time point of irradiation (XRT) after incomplete resection (immediate XRT versus XRT at progression of residual tumor).
Results: Up to now (12/09) 52 pts with CP were recruited (29 pts in the randomization arm; 19 pts in the surveillance arm; 4 pts in the process of review of imaging). 11 of 29 pts were randomized. 7 pts could not be randomized due to parental decision, late schedule (6 pts) and due to decision of the physician (5 pts).
Conclusions: In conclusion, KRANIOPHARYNGEOM 2007 represents the first randomized trial in CP and the first study in pediatric neurooncology analyzing QoL as an endpoint. Aim of the study is to analyze the appropriate time point of XRT in order to improve QoL in patients with hypothalamic involvement.
Supported by Deutsche Kinderkrebsstiftung (www.kinderkrebsstiftung.de).