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
Secondary identifying numbers	N/A

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

Unit of Advanced Palliative Home Care
(Linköpings Avancerad Hemsjukvård [LAH])
Linköping Regional Hospital (Regionsjukhuset i Linköping)
Linköping
581 85
Sweden

Study information

Study design	Multicentre open label randomised active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient 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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Temozolomide (Temodal®) (TMZ)
Primary outcome measure	1. Survival
Secondary outcome measures	1. Quality of Life 2. Symptom control 3. Safety 4. Health resource utilization
Overall study start date	01/02/2000
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	Planned 480, stopped at 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

Sponsor information

Nordic Clinical Brain Tumor Study group (Sweden)
Other

c/o Prof Roger Henriksson
Radiumhemmet
Karolinska Hospital in Solna
Stockholm
17176
Sweden

Funders

Funder type

Other

Nordic Clinical Brain Tumor 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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2012		Yes	No