Condition category
Cancer
Date applied
04/08/2005
Date assigned
04/08/2005
Last edited
10/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.amc.uva.nl/

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

Publication citations

Additional files

Editorial Notes