Local stage II or III intermediate risk nephroblastoma after pre-operative chemotherapy and surgery.
Conditions
Interventions
Establishing equivalence between 2 post-operative treatments. Trialarm with Doxorubicine versus Trialarm without Doxorubicin.
Sponsors
Emma Kinderziekenhuis AMC, Amsterdam (the Netherlands).
UKCCSG Data Centre, University of Leicester (UK); Universitätsklinik für Kinder- und Jugendsmedizin (Germany).
Séverine Guillemaut, Unité de Biostatistiques et d'Evaluation des Thérapeutiques (France).
Eligibility
Inclusion criteria
Inclusion criteria: 1. All localised disease nephroblastoma patients age more than 6 months or less than 18 years at time of diagnosis. Unilateral tumour with clinical and ultrasonic characteristics compatible with nephroblastoma or biopsy proven histological diagnosis. 2. Written informed consent and national ethical committee approval. 3. Stage II and III intermediate risk histology after pre-treatment according to protocol and after operation.
Exclusion criteria
Exclusion criteria: 1. All other kind of renal tumours of infancy. 2. Patients without previous anti-tumour treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event Free Survival (EFS). | — |
Contacts
Public ContactSIOP Nephroblastoma Trial and Study Office
Academic Medical Center (AMC), Emma Children's Hospital, P.O. Box 22660
Outcome results
None listed