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

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Trial of chemotherapy utilising carboplatin, vincristine, cyclophosphamide and etoposide for the treatment of central nervous system primitive neurectodermal tumours of childhood
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Brain and nervous system cancer
Intervention	All 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 type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Carboplatin, vincristine, cyclophosphamide, etoposide
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1998
Completion date	28/01/2000

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Years
Upper age limit	16 Years
Sex	Both
Target number of participants	Not provided at time of registration
Key inclusion criteria	1. 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 criteria	Not provided at time of registration
Date of first enrolment	01/01/1998
Date of final enrolment	28/01/2000

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Cancer Research UK (CRUK) (UK)
Charity

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

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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

23/01/2019: Publication reference added.