A randomised study of two schedules of radiotherapy or chemotherapy in elderly patients with high grade glioma
| ISRCTN | ISRCTN81470623 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81470623 |
| Protocol serial number | N/A |
| Sponsor | Nordic Clinical Brain Tumor Study group (Sweden) |
| Funder | Nordic Clinical Brain Tumor Study group (Sweden) |
- Submission date
- 12/02/2010
- Registration date
- 03/03/2010
- Last edited
- 30/10/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Annika Malmström
Scientific
Scientific
Unit of Advanced Palliative Home Care
(Linköpings Avancerad Hemsjukvård [LAH])
Linköping Regional Hospital (Regionsjukhuset i Linköping)
Linköping
581 85
Sweden
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre open label randomised active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A multicentre randomised active controlled study comparing two schedules of radiotherapy or chemotherapy in elderly patients with high grade glioma |
| Study acronym | Temodal elderly |
| Study objectives | To compare conventional radiotherapy (RT) (2 Gy up to 60 Gy) to short term RT (3.4 Gy up to 34 Gy) or chemotherapy alone after surgery or biopsy. |
| Ethics approval(s) | The Linköping Ethics Committee approved in April 1999 (ref: Dnr 99086) |
| Health condition(s) or problem(s) studied | Malignant glioma, grade 3-4 or 4 |
| Intervention | Patients were randomised to either 1. Standard RT (60 Gy in 2 Gy fractions over 6 weeks) 2. Hypofractionated RT (34 Gy in 3,4 Gy fractions over 2 weeks) 3. 6 cycles of chemotherapy with TMZ (200 mg/m2 day 1-5 every 28 days) |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Temozolomide (Temodal®) (TMZ) |
| Primary outcome measure(s) |
1. Survival |
| Key secondary outcome measure(s) |
1. Quality of Life |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 342 |
| Key inclusion criteria | 1. Age > 60 2. Performance Status (PS) 0-2 according to the WHO definition. Patients with a general condition corresponding to WHO 0-2, but due to physical handicap are graded as PS 3 or 4 can also be included. 3. Patients with histologically/cytologically confirmed glioma grade 3-4 or 4 4. Expected to tolerate all three treatment options 5. Life expectancy of at least 3 months 6. General organ function allowing chemotherapy as indicated by: 6.1. Neutrophiles > 1.5 x 109/l 6.2. Platelets > 100 x 109/l 6.3. Haemoglobin > 10 g/dl (100g/l) 6.4. Serum creatinine and bilirubin < 1.5 times upper normal limit 6.5. Aspartate Aminotransferase (ASAT), alanine Aminotransferase (ALAT) < 3 times upper normal limit 7. No other medical condition likely to interfere with treatment or the assessment of its efficacy 8. Patient is on the lowest steroid dose, which gives optimal functional improvement 9. Written informed consent |
| Key exclusion criteria | 1. Patients with other primary cancer, with the exception of radically treated squamous or basal cell carcinoma of the skin or other curatively treated malignancy without relapse 2 years after diagnosis 2. PS WHO grade 3-4, except for patients with a general condition corresponding to WHO 0-2, but due to physical handicap are graded as PS 3 or 4 3. Any other medical condition which, in the view of the investigator, is a contraindication to inclusion in the study 4. Chemotherapy, biological therapy, radiotherapy or immunotherapy given previously for brain tumour or within 3 years for other malignancy 5. Radiotherapy to the head, which would interfere with giving radiotherapy treatment for brain tumour |
| Date of first enrolment | 01/02/2000 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Austria
- Denmark
- France
- Norway
- Sweden
- Switzerland
- Türkiye
Study participating centre
Unit of Advanced Palliative Home Care
Linköping
581 85
Sweden
581 85
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
