Temozolomide in children with recurrent or refractory central nervous system (CNS) tumours [Temozolomide bij kinderen met een gerecidiveerde of refractaire centraal zenuwstelsel tumor]
| ISRCTN | ISRCTN16192422 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16192422 |
| Protocol serial number | NTR227 |
| Sponsor | Dutch Childhood Oncology Group (Stichting Kinder Oncologie [SKION]) (The Netherlands) |
| Funders | Added as of 24/06/2008:, Schering-Plough B.V. (The Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 24/06/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr R.E. Reddingius
Scientific
Scientific
Erasmus Medical Center
Sophia Children's Hospital
Rotterdam
3015 GJ
Netherlands
| Phone | +31 (0)10 463 6363 |
|---|---|
| r.reddingius@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, multicentre, active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | TMZ studie |
| Study objectives | Administration of a higher cumulative dose of temozolomide leads to a higher response rate in patients with recurrent primitive neuro-ectodermal tumours and recurrent high grade gliomas of the central nervous system (CNS), while this treatment does not lead to more side effects. Please note that as of 24/06/2008 more details on the sources of funding have been added to this record (i.e., funding now confirmed). This can be seen below in the sources of funding section. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Glioma high grade, primitive neuroectodermal tumour (PNET) |
| Intervention | Two different dose schedules of temozolomide are compared: 1. In the standard arm 200 mg/m^2/dag is administered 5 days per 28 days 2. In the experimental arm 150 mg/m^2 is administered 2 x 7 dagen (day 0 - 6 and day 14 - 20) per 28 days |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Temozolomide |
| Primary outcome measure(s) |
Difference in magnetic resonance imaging (MRI) response after 12 weeks between the two arms. |
| Key secondary outcome measure(s) |
Difference in side effects after 12 weeks between the two arms. |
| Completion date | 01/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 54 |
| Key inclusion criteria | 1. Aged 3 - 18 years 2. Pathology: primitive neuroectodermal tumour (PNET)/high grade glioma 3. Measurable tumour 4. Lansky score greater than 50% 5. Expected life span of 12 weeks or more 6. Informed consent |
| Key exclusion criteria | Non-conformation to inclusion criteria |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 01/01/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands
3015 GJ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
