Study protocol

Study protocol of the German "Registry for the Detection of Late Sequelae after Radiotherapy in Childhood and Adolescence" (RiSK)

Tobias Bolling¹ , Andreas Schuck² , Hildegard Pape³ , Christian Rube⁴ , Barbara Pollinger⁵ , Beate Timmermann⁶ , Rolf D Kortmann⁷ , Karin Dieckmann⁸ and Normann Willich¹

¹Department of Radiotherapy, University Hospital of Münster, Germany

²Radiotherapy Facility, Memmingen, Germany

³Department of Radiotherapy, University Hospital of Düsseldorf, Germany

⁴Department of Radiotherapy, University Hospital of Homburg/Saar, Germany

⁵Department of Radiotherapy, University Hospital of Munich, Germany

⁶Department of Radiotherapy of the Paul-Scherrer-Institute, Villigen, Switzerland

⁷Department of Radiotherapy, University Hospital of Leipzig, Germany

⁸Department of Radiotherapy, University Hospital of Vienna, Austria

author email corresponding author email

Radiation Oncology 2008, 3:10doi:10.1186/1748-717X-3-10

Published:	21 April 2008

Abstract

Background

Late effects after radiotherapy in childhood and adolescence have mainly been characterized retrospectively with small patient numbers. However, these analyses are limited due to little information regarding organ dose levels in many cases. To overcome this limitation, the German Group of Paediatric Radiation Oncology (APRO) established the „Registry for the evaluation of late side effects after radiation in childhood and adolescence” (RiSK). The study protocol and the documentation forms are given in this publication.

Methods/Design

Radiation parameters including detailed organ doses as well as toxicity evaluations are collected prospectively from centres all over Germany. Standardized documentation forms are used. These forms are given in an English and German version as additional files to this publication. Documentation is planned for all children who receive radiotherapy in one of the therapy trials of the "German Society of Paediatric Oncology and Haematology (GPOH)". The study started in a pilot phase in June 2001 in few centres. Since 2004 documentation has been performed all over Germany and is still on-going.

Discussion

To our knowledge, "RiSK" is the only multi-centre study that evaluates radiation associated side effects prospectively with detailed information about organ dose levels. With ongoing recruitment and prolongation of follow-up powerful data will be obtained in a few years. A broad use and international cooperation are welcome.