Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A multicentre, phase III, randomised controlled trial of radiotherapy and concomitant Temodal® (temozolomide) or neoadjuvant chemotherapy followed by radiotherapy and concomitant Temodal® in patients with high grade glioma
Acronym
Temodal, neoadjuvant trial
Study hypothesis
To compare the efficacy and safety of conventional and concomitant Temodal® in patients with anaplastic astrocytoma (AA) or glioblastoma multiforme (GBM).
Ethics approval
The local ethics committee (Ethic comitteé Umeà) approved in August 2008 (ref: 02-317)
Study design
Multicentre prospective phase III randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Written and oral
Condition
Grade III (anaplastic astrocytoma) or grade IV (glioblastoma multiforme) tumours
Intervention
Patients will be randomised to receive either
1. Conventional radiotherapy and temozolomide:
60 Gy radiotherapy is administered in 2 Gy fractions over 6 weeks, concomitantly with daily doses of temozolomide 75 mg/m2
2. Neoadjuvant temozolomide 2-3 cycles followed by radiotherapy
3 cycles of temozolomide dosage 200 mg/m2 days 1-5 in a 28 days schedule, with radiologic evaluation before start of treatment and after 2 cycles. If progression is noted cycle 3 is omitted. Radiotherapy is administered in the same way as for the standard treatment arm.
Follow up for both treatment arms is 1 ond 3 months after end of treatment.
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measures
Overall survival
Secondary outcome measures
1. Safety, all adverse events are collected
2. Quality of Life (QoL), evaluated by the EORTC QLQ-30 before start of treatment, then 12 and 24 months after start of treatment.
Overall trial start date
13/01/2003
Overall trial end date
21/05/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Written informed consent
2. Histologically proven astrocytic glioma (grade III: AA or grade IV: GBM)
3. Age 18 - 60 years
4. Performance status WHO 0-2
5. Life expectancy > 3 months
6. Normal organ function, except if abnormal due to tumour involvement as indicated by:
6.1. Platelet count (TPK) < 100 x 10^9/L
6.2. Haemoglobin (Hb) > 90 g/L
6.3. Neutrophils: < 1.5 x 10^3/mm3 or LPK < 3.0 x 10^9/L
6.4. Serum creatinine and bilirubin < 1.5 times the upper limit of normal (ULN)
6.5. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) < 3 x ULN
7. Men and women of child bearing potential must be using adequate contraception
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Planned 322, stopped at 143
Participant exclusion criteria
1. Prior chemotherapy or radiotherapy for malignant glioma
2. Any other active malignancies within the last 5 years, except adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ
3. Pregnancy or breast feeding
4. Any condition (medical, social, psychological) which would prevent adequate information and follow up
Recruitment start date
13/01/2003
Recruitment end date
21/05/2009
Locations
Countries of recruitment
Denmark, Finland, Norway, Sweden
Trial participating centre
Radiumhemmet
Stockholm
171 74
Sweden
Funders
Funder type
Research organisation
Funder name
Nordic Clinical Brain Tumour Study Group (Sweden)
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