Contact information
Type
Scientific
Primary contact
Dr J de Kraker
ORCID ID
Contact details
SIOP Nephroblastoma Trial and Study Office
Meibergdreef 9
room A3-273
Amsterdam
1105 AZ
Netherlands
+31 (0)20 5665697
siop-wilms@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR58
Study information
Scientific title
Acronym
SIOP 2001
Study hypothesis
1. 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
2. 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
3. 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.
4. 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
5. To determine prospectively the prognostic significance of tumour volume following pre-operative chemotherapy and its relation to histological subtype
6. To determine prospectively the prognostic significance of specimen weight at time of nephrectomy and its relation to histological subtype
7. To reduce the number of drug administrations, hospital visits and thereby costs in the preoperative phase
Ethics approval
Ethics approval received from local ethics committee.
Study design
Randomised, double-blind, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Nephroblastoma
Intervention
Establishing equivalence between two post-operative treatments. Trial arm with doxorubicin versus trial arm without doxorubicin.
Intervention type
Drug
Phase
Not Specified
Drug names
Doxorubicin
Primary outcome measures
Event free survival (EFS).
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/06/2002
Overall trial end date
01/06/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. All localised disease nephroblastoma patients age more than 6 months or less than 18 years at time of diagnosis
2. Unilateral tumour with clinical and ultrasonic characteristics compatible with nephroblastoma or biopsy proven histological diagnosis
3. Written informed consent and national ethical committee approval
4. Stage II and III intermediate risk histology after pre-treatment according to protocol and after operation
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
350
Participant exclusion criteria
1. All other kind of renal tumours of infancy
2. Patients without previous anti-tumour treatment
Recruitment start date
01/06/2002
Recruitment end date
01/06/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
SIOP Nephroblastoma Trial and Study Office
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (The Netherlands)
Sponsor details
Emma Kinderziekenhuis
Postbus 22660
Amsterdam
1105 AZ
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
The Foundation of Paediatric Cancer Research (Stichting Kindergeneeskundig Kankeronderzoek [SKK]) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
German Cancer Aid (Deutsche Krebshilfe) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Swedish Childhood Cancer Foundation (Barncancerfonden) (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary