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 (NCT) | NCT00003859 |
| Protocol serial number | CNS9102 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funder | Cancer Research UK |
- 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
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Carboplatin, vincristine, cyclophosphamide, etoposide |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 28/01/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 16 Years |
| Sex | All |
| 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
23/01/2019: Publication reference added.