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

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.