Trial of chemotherapy utilising carboplatin, vincristine, cyclophosphamide and etoposide for the treatment of central nervous system primitive neurectodermal tumours of childhood

ISRCTN ISRCTN37367725
DOI https://doi.org/10.1186/ISRCTN37367725
ClinicalTrials.gov number NCT00003859
Secondary identifying numbers CNS9102
Submission date
01/07/2001
Registration date
01/07/2001
Last edited
23/01/2019
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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleTrial of chemotherapy utilising carboplatin, vincristine, cyclophosphamide and etoposide for the treatment of central nervous system primitive neurectodermal tumours of childhood
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBrain and nervous system cancer
InterventionAll patients receive surgery followed by either:
1. Schedule A: Radiotherapy alone
2. Schedule B: Initial chemotherapy (carboplatin, vincristine, cyclophosphamide and etoposide) followed by radiotherapy
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Carboplatin, vincristine, cyclophosphamide, etoposide
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1998
Completion date28/01/2000

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit3 Years
Upper age limit16 Years
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteria1. Aged 3 to 16 years
2. Survival period of at least 1 week following surgery
3. Post-operative Computed Tomography (CT) scan and myelogram
4. No concomitant haematological disorder
5. No previous history of malignant disease
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/1998
Date of final enrolment28/01/2000

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Phone +44 (0)207 317 5186
Email kate.law@cancer.org.uk
Website http://www.cancer.org.uk
ROR logo "ROR" https://ror.org/054225q67

Funders

Funder type

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article patient stratification results 15/08/2004 Yes No
Results article follow-up results 20/09/2007 Yes No
Results article results for supratentorial primitive neuro-ectodermal tumours (SPNET) subset 01/07/2009 Yes No
Results article radiotherapy duration results 15/03/2004 23/01/2019 Yes No
Results article results 15/04/2003 23/01/2019 Yes No

Editorial Notes

23/01/2019: Publication reference added.