Who can enter
- Children with metastatic kidney cancer at diagnosis
- Children older than 3 months and up to 18 years old
Goal
The aim of this study is to find out whether a new treatment for children with metastatic renal tumor works at least as well as the standard treatment. It is expected that the (long-term) side effects of the new treatment will be less.
Background
All children with renal tumors are treated according to the SIOP-RTSG 2016 UMBRELLA protocol. Currently, children with metastatic renal tumors are first treated with chemotherapy, i.e. vincristine, actinomycin-D and doxorubicin (VAD) for 6 weeks. This is followed by surgery to remove the tumor, then followed by another 6+ months of chemotherapy according to normal care. This treatment works well, but might also cause long-term side effects. In particular, actinomycin-D and doxorubicin can lead to immediate and/or later problems with liver and/or heart function.
This study is for children registered in the UMBRELLA trial who are found to have metastatic disease after diagnosis. These children will be asked to participate in the RANDOMET study comparing a new treatment with vincristine, carboplatin and etoposide (VCE) with the normal treatment with VAD. Half of the patients will receive the normal treatment with VAD and the other half will receive the treatment with VCE. Patients will be randomized to determine which treatment a child will receive. We will investigate whether treatment with VCE works at least as well as the normal treatment with VAD. We will also look at the side effects and long-term effects of the treatments.