Contact information
Type
Scientific
Primary contact
Dr R.E. Reddingius
ORCID ID
Contact details
Erasmus Medical Center
Sophia Children's Hospital
Rotterdam
3015 GJ
Netherlands
+31 (0)10 463 6363
r.reddingius@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR227
Study information
Scientific title
Acronym
TMZ studie
Study hypothesis
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
Not provided at time of registration
Study design
Randomised, multicentre, active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Temozolomide
Primary outcome measure
Difference in magnetic resonance imaging (MRI) response after 12 weeks between the two arms.
Secondary outcome measures
Difference in side effects after 12 weeks between the two arms.
Overall trial start date
01/01/2004
Overall trial end date
01/01/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
54
Participant exclusion criteria
Non-conformation to inclusion criteria
Recruitment start date
01/01/2004
Recruitment end date
01/01/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands
Sponsor information
Organisation
Dutch Childhood Oncology Group (Stichting Kinder Oncologie [SKION]) (The Netherlands)
Sponsor details
Leyweg 299
Den Haag
2545 CJ
Netherlands
+31 (0)70 367 4545
info@skion.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Industry
Funder name
Added as of 24/06/2008:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Schering-Plough B.V. (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list