Trial of pre-operative chemotherapy in biopsy proven Wilms tumour versus immediate nephrectomy

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Kidney, solid tumour of childhood
Intervention	1. Treatment A: Immediate surgery, nephrectomy 2. Treatment B: Tumour biopsy and pre-operative chemotherapy followed by nephrectomy
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Cancer drugs
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2001

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	16 Years
Sex
Key inclusion criteria	1. Over 6 months and under 16 years of age at diagnosis 2. Clinical and radiological evidence of Wilm's tumour 3. No previous treatment for Wilm's tumour 4. Tumour is deemed operable 5. No evidence of metastases
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/1991
Date of final enrolment	31/12/2001

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2006		Yes	No