RANDOMET
Recruiting
Who can enter
Children with metastatic kidney cancer at diagnosis
Children older than 3 months and up to 18 years old
Goal
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
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.
In order to participate in a study please refer to your/your child’s doctor.
Last reviewed
Last reviewed
March 23, 2026
Study details
- Study details
Official title
Randomized multi-centre open-label non-inferiority phase 3 clinical trial for patients with a stage IV childhood renal tumor comparing upfront Vincristine, Actinomycin-D and Doxorubicin (VAD, standard arm) with upfront Vincristine, Carboplatin and Etoposide (VCE, experimental arm)Cancer type
Metastatic kidney cancerPhase
3Maximum number of patients
406, of whom 25 patients are expected to be enrolled in the NetherlandsStart date
April 5, 2024Status
OpenLocal principal investigator
Dr. M. van Grotel (local)
Prof. dr. M. M. van den Heuvel-Eibrink (national)Sponsor
Gesellschaft für pädiatrische Onkologie und Hämatologie gGmbH, BerlinApproval
The study of this new treatment has been reviewed by an accredited medical research ethics committee. This committee has decided that it is justified to ask patients to participate in this study. More information can be found at: CCMO.Trial registry number
Clinicaltrial.gov: NCT03669783
Clinicaltrialsregister.eu: 2018-000533-13
The above information is intended as a brief summary only and may not reflect the most up-to-date information. For full details and the current status of a protocol, physicians can contact the Princess Máxima Center directly.