Condition category
Cancer
Date applied
12/02/2010
Date assigned
03/03/2010
Last edited
30/10/2012
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 Annika Malmström

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A multicentre randomised active controlled study comparing two schedules of radiotherapy or chemotherapy in elderly patients with high grade glioma

Acronym

Temodal elderly

Study hypothesis

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

The Linköping Ethics Committee approved in April 1999 (ref: Dnr 99086)

Study design

Multicentre open label randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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 names

Temozolomide (Temodal®) (TMZ)

Primary outcome measures

1. Survival

Secondary outcome measures

1. Quality of Life
2. Symptom control
3. Safety
4. Health resource utilization

Overall trial start date

01/02/2000

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned 480, stopped at 342

Participant 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

Recruitment start date

01/02/2000

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Austria, Denmark, France, Norway, Sweden, Switzerland, Turkey

Trial participating centre

Unit of Advanced Palliative Home Care
Linköping
581 85
Sweden

Sponsor information

Organisation

Nordic Clinical Brain Tumor Study group (Sweden)

Sponsor details

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

Sponsor type

Other

Website

Funders

Funder type

Other

Funder name

Nordic Clinical Brain Tumor 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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22877848

Publication citations

  1. Results

    Malmström A, Grønberg BH, Marosi C, Stupp R, Frappaz D, Schultz H, Abacioglu U, Tavelin B, Lhermitte B, Hegi ME, Rosell J, Henriksson R, , Temozolomide versus standard 6-week radiotherapy versus hypofractionated radiotherapy in patients older than 60 years with glioblastoma: the Nordic randomised, phase 3 trial., Lancet Oncol., 2012, 13, 9, 916-926, doi: 10.1016/S1470-2045(12)70265-6.

Additional files

Editorial Notes