An investigation of the predictability of carboplatin plasma concentrations in children following dosing on the basis of surface area of renal function

ISRCTN ISRCTN79815499
DOI https://doi.org/10.1186/ISRCTN79815499
Protocol serial number NAG9402
Sponsor Cancer Research UK (CRUK) (UK)
Funders Cancer Research UK, United Kingdom Children's Cancer Study Group (UKCCSG)
Submission date
01/07/2001
Registration date
01/07/2001
Last edited
01/02/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr - -
Scientific

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

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCancer of brain and nervous system
InterventionPatients receiving two courses of carboplatin are randomised to one of two groups:

1. Group A: Surface area based (course I) followed by renal function based (course II) measurement.
2. Group B: Renal function based (course I) followed by surface area based (course II) measurement.
Intervention typeOther
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date28/02/1997

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit18 Years
Sex
Key inclusion criteria1. Aged under 18 years
2. Receiving carboplatin on at least two occasions
3. Being treated according to listed UKCCSG protocols (NB9001, NB9301, NB8702, GC8901, CNS9204, CNS9102, WAG8702)
4. Tumour site: Neuroblastoma; Extra-cranial germ cell; Brain
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/1993
Date of final enrolment28/02/1997

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2000 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes