No registrations found.
ID
Source
Brief title
Health condition
Local stage II or III intermediate risk nephroblastoma after pre-operative chemotherapy and surgery.
Sponsors and support
UKCCSG Data Centre, University of Leicester (UK); Universitätsklinik für Kinder- und Jugendsmedizin (Germany).
Séverine Guillemaut, Unité de Biostatistiques et d'Evaluation des Thérapeutiques (France).
Deutsche Krebshilfe (Germany).
Barncancerfonden (Sweden).
Intervention
Outcome measures
Primary outcome
Event Free Survival (EFS).
Secondary outcome
N/A
Background summary
N/A
Study objective
To continue a risk-adapted stratification of therapeutic intensity, incorporating response to pre-operative chemotherapy, in all children with Wilms tumour and other renal tumours of childhood.
To test the treatment hypothesis that doxorubicin is not necessary in patients with intermediate risk tumours and local stage II or III by a multicentre prospective randomised trial.
To determine prospectively the prognostic significance of specific histological subtypes following pre-operative chemotherapy, as specified in the protocol. In particular, the study aims to: confirm the adverse prognostic significance of the blastemal predominant subtypes and whether this can be offset by intensifying therapy and investigate the hypothesis that the epithelial and stromal-predominant subtypes have a favourable prognosis and investigate the prognostic significance of the percentage necrosis after pre-operative chemotherapy in relation to the type and amount of residual viable tumour.
To minimise acute and late toxicity without jeopardising event free and overall survival by reducing treatment for: patients with focal anaplasia, and patients with stage I, intermediate risk tumours.
To determine prospectively the prognostic significance of tumour volume following pre-operative chemotherapy and its relation to histological subtype.
To determine prospectively the prognostic significance of specimen weight at time of nephrectomy and its relation to histological subtype.
To reduce the number of drug administrations, hospital visits and thereby costs in the preoperative phase.
Intervention
Establishing equivalence between 2 post-operative treatments. Trialarm with Doxorubicine versus Trialarm without Doxorubicin.
P.O. Box 22660
SIOP Nephroblastoma Trial and Study Office
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5665697
siop-wilms@amc.uva.nl
P.O. Box 22660
SIOP Nephroblastoma Trial and Study Office
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5665697
siop-wilms@amc.uva.nl
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
1. All other kind of renal tumours of infancy.
2. Patients without previous anti-tumour treatment.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL33 |
| NTR-old | NTR58 |
| Other | : N/A |
| ISRCTN | ISRCTN16583459 |