The current standard therapy for children and adolescents with metastatic kidney cancer is a brief course of chemotherapy followed by surgery to remove the tumour and a longer course of chemotherapy after the operation. Some patients need radiotherapy in addition. One of the main problems with this therapy is the serious, life-threatening side effects that the chemotherapy before surgery can sometimes cause.
About three children and adolescents in Switzerland are affected by this disease annually and can take part in the SIOP Randomet 2017 trial.
The main aim of SIOP Randomet 2017 is to reduce the severe side effects associated with the chemotherapy prior to surgery. This trial is therefore studying the current therapeutic standard before surgery in comparison with another therapy. The aim is to see whether the comparator therapy, with which side effects are less common and less severe, can cure the disease as well as the standard therapy.
A further aim is to establish a quality-assurance network of reference assessors and to provide a treatment plan of the highest scientific standard. Before treatment begins, radiological images (e.g. ultrasound and MRI images) of the patients will be sent to an expert team who will check for the presence of metastases outside the kidney tumour. This second opinion will ensure that the diagnosis is as reliable as possible without delaying therapy unnecessarily. Throughout the therapy, the doctors treating the patients in the trial will also be able to draw on the knowledge and expertise of radiologists, surgeons and the international trials office, all of whom are familiar with the treatment of many children with this cancer. In addition, samples of the tumour that has been removed surgically will be examined in a laboratory by an experienced reference pathologist. The results of this examination can have a major influence on the choice of subsequent chemotherapy and the decision on whether or not to perform radiotherapy.
The Society of Paediatric Oncologists and Haematologists (GPOH) in Germany is responsible for the international implementation of the trial (sponsor). The Swiss Paediatric Oncology Group (SPOG) is responsible for performing the trial in Switzerland (sponsor’s representative).
In short
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This study is investigating how the treatment of children and adolescents with a metastatic renal tumour can be improved.
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A central problem of the current standard treatment is posed by the severe, life-threatening side effects, including infections and kidney damage, that can be caused by chemotherapy.
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This study is comparing the efficacy of a new chemotherapy, with which these side effects occur less frequently and are not as serious, and the current standard chemotherapy.
