Condition category
Cancer
Date applied
25/08/2010
Date assigned
23/09/2010
Last edited
07/09/2011
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

Prof Roger Henriksson

ORCID ID

Contact details

Radiumhemmet
Karolinska sjukhuset i Solna
Stockholm
171 74
Sweden

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

Sponsor information

Organisation

Nordic Clinical Brain Tumour Study Group (Sweden)

Sponsor details

c/o Prof Roger Henriksson
Radiumhemmet
Karolinska sjukhuset i Solna
Stockholm
171 74
Sweden

Sponsor type

Research organisation

Website

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

Publication citations

Additional files

Editorial Notes