A randomised study of radiotherapy and concomitant Temodal® (temozolomide) or neoadjuvant chemotherapy followed by radiotherapy and concomitant Temodal® in patients with high grade glioma
| ISRCTN | ISRCTN45209900 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45209900 |
| Secondary identifying numbers | N/A |
- Submission date
- 25/08/2010
- Registration date
- 23/09/2010
- Last edited
- 07/09/2011
- 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
Prof Roger Henriksson
Scientific
Scientific
Radiumhemmet
Karolinska sjukhuset i Solna
Stockholm
171 74
Sweden
Study information
| Study design | Multicentre prospective phase III randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Written and oral |
| 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 |
| Study acronym | Temodal, neoadjuvant trial |
| Study objectives | To compare the efficacy and safety of conventional and concomitant Temodal® in patients with anaplastic astrocytoma (AA) or glioblastoma multiforme (GBM). |
| Ethics approval(s) | The local ethics committee (Ethic comitteé Umeà) approved in August 2008 (ref: 02-317) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 13/01/2003 |
| Completion date | 21/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Planned 322, stopped at 143 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 13/01/2003 |
| Date of final enrolment | 21/05/2009 |
Locations
Countries of recruitment
- Denmark
- Finland
- Norway
- Sweden
Study participating centre
Radiumhemmet
Stockholm
171 74
Sweden
171 74
Sweden
Sponsor information
Nordic Clinical Brain Tumour Study Group (Sweden)
Research organisation
Research organisation
c/o Prof Roger Henriksson
Radiumhemmet
Karolinska sjukhuset i Solna
Stockholm
171 74
Sweden
Funders
Funder type
Research organisation
Nordic Clinical Brain Tumour Study Group (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
