Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
24/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.skion.nl/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes