Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000427471
Ethics application status
Approved
Date submitted
18/04/2007
Date registered
22/08/2007
Date last updated
7/03/2023
Date data sharing statement initially provided
10/12/2019
Date results provided
7/03/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Radiation Therapy or Temozolomide in Treating Patients With Gliomas
Scientific title
Trans Tasman Radiation Oncology Group (TROG) 06.01 - Primary Chemotherapy With Temozolomide Versus Radiotherapy in Patients With Low Grade Gliomas After Stratification for Genetic 1p Loss: A Phase III Study to demonstrate a difference in progression free survival.
Secondary ID [1] 438 0
Clinicaltrials.gov: NCT00182819
Universal Trial Number (UTN)
Trial acronym
TROG 06.01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain and Central Nervous System Tumors 2151 0
Condition category
Condition code
Cancer 2243 2243 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm B: Temozolomide administered orally 75 mg/m2 daily x 21 days (one cycle), q 28 days until progression or for max. 12 cycles (experimental arm)
Intervention code [1] 1707 0
Treatment: Drugs
Comparator / control treatment
Arm A: Radiotherapy (control arm), 50.4 Gy, standard fractionation (28 fractions
x 1.8 Gy, 5 days per week, duration is 6 weeks), conformal techniques
Control group
Active

Outcomes
Primary outcome [1] 3105 0
Progression Free Survival (PFS) - PFS is the time interval between the date of randomization and the date of disease progression or death, whichever comes first. If neither event has been observed, then the patient is censored at the date of the last follow up examination.
Timepoint [1] 3105 0
The first follow-up (FU) will be performed 3 months after the start of therapy, then at 3-monthly intervals until progression. After progression patients are followed every 6 months for survival until death.
Secondary outcome [1] 5451 0
Overall survival
Timepoint [1] 5451 0
Measured every 3 months until progression and then every 6 months until death
Secondary outcome [2] 5452 0
Quality of Life
Timepoint [2] 5452 0
Measured by QLQ-C30 v3.0 and EORTC BN-20 every 3 months until progression, and then every 6 months until death
Secondary outcome [3] 5453 0
Mini Mental State Examination
Timepoint [3] 5453 0
Measured every 3 months until progression and then every 6 months until death
Secondary outcome [4] 5454 0
Adverse Events
Timepoint [4] 5454 0
As measured by CTCAE v3.0 every 3 months until progression and then every 6 months until death.

Eligibility
Key inclusion criteria
At registration:
- Histologically proven low grade diffuse glioma astrocytoma WHO grade II (gemistocytic, fibrillary and protoplasmatic)
oligoastrocytoma WHO grade II oligodendroglioma WHO II
- Supratentorial location only
- WHO performance status = 2
- Not candidate for treatment exclusively by surgery
- RTOG neurological function 0-3
- Results of genetic testing (1p) available
- Adequate haematological, renal and hepatic function
- Histopathologic slides available for central pathology review
- Tumour material (paraffin-embedded) and blood available for molecular testing
- Written informed consent
At randomisation:
Same as above PLUS
- Requiring treatment as demonstrated by at least one of the following criteria (1-4):
1. Age = 40 years
2. Radiologically proven progressive lesion
3. New or worsening neurological symptoms other than seizures only (focal deficits, signs of raised intracranial pressure, mental deficits)
4. Intractable seizures, defined as having both:
persistent seizures interfering with everyday life activities other than driving a car
AND
failed three lines of anti-epileptic drug regimen, including at least one combination regimen
- RTOG Neurological Function 0-3
- Not candidate for treatment exclusively with surgery
- Must have recovered from any prior surgery
- 1p test result available (for stratification: 1p deleted versus 1p normal versus undeterminable)
- Baseline quality of life questionnaires (QLQ-C30 + BN20) completed
- Prepared to use effective contraception for the duration of the treatment and for 6 months after(applies to all patients with reproductive potential - male and female)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous irradiation of the brain
- Previous chemotherapy
- Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and non-melanoma skin cancer
- Known HIV infection, chronic hepatitis B or hepatitis C infection
- Any other serious medical contraindication as per the judgment of the treating physician
- Any medical condition which could interfere with oral medication intake (e.g. frequent vomiting, partial bowel obstruction)
- Female pregnant or lactating
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule as discussed with the patient before randomization

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone /computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple Randomisation by computer. Stratified allocation. Factors: institution, 1p deleted versus 1p normal versus undeterminable, contrast enhancement: +/- contrast on MRI, age: <40 years versus = 40 years, WHO performance status: 0 or 1 versus 2.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/07/2005
Actual
17/08/2005
Date of last participant enrolment
Anticipated
Actual
26/03/2010
Date of last data collection
Anticipated
1/01/2030
Actual
Sample size
Target
699
Accrual to date
Final
709
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment outside Australia
Country [1] 5584 0
Belgium
State/province [1] 5584 0
Country [2] 5585 0
France
State/province [2] 5585 0
Country [3] 5586 0
Netherlands
State/province [3] 5586 0
Country [4] 5587 0
Switzerland
State/province [4] 5587 0
Country [5] 5588 0
Canada
State/province [5] 5588 0
Country [6] 5589 0
Austria
State/province [6] 5589 0
Country [7] 5590 0
Germany
State/province [7] 5590 0
Country [8] 5591 0
Israel
State/province [8] 5591 0
Country [9] 5592 0
Spain
State/province [9] 5592 0
Country [10] 5593 0
Hungary
State/province [10] 5593 0
Country [11] 5594 0
United Kingdom
State/province [11] 5594 0
Country [12] 5595 0
Portugal
State/province [12] 5595 0
Country [13] 5596 0
Egypt
State/province [13] 5596 0
Country [14] 5597 0
Sweden
State/province [14] 5597 0
Country [15] 5598 0
Luxembourg
State/province [15] 5598 0
Country [16] 5599 0
Singapore
State/province [16] 5599 0
Country [17] 5600 0
New Zealand
State/province [17] 5600 0
Country [18] 5601 0
Belgium
State/province [18] 5601 0
Country [19] 5602 0
France
State/province [19] 5602 0
Country [20] 5603 0
Netherlands
State/province [20] 5603 0
Country [21] 5604 0
Switzerland
State/province [21] 5604 0
Country [22] 5605 0
Canada
State/province [22] 5605 0
Country [23] 5606 0
Austria
State/province [23] 5606 0
Country [24] 5607 0
Germany
State/province [24] 5607 0
Country [25] 5608 0
Israel
State/province [25] 5608 0
Country [26] 5609 0
Spain
State/province [26] 5609 0
Country [27] 5610 0
Hungary
State/province [27] 5610 0
Country [28] 5611 0
United Kingdom
State/province [28] 5611 0
Country [29] 5612 0
Portugal
State/province [29] 5612 0
Country [30] 5613 0
Egypt
State/province [30] 5613 0
Country [31] 5614 0
Sweden
State/province [31] 5614 0
Country [32] 5615 0
Luxembourg
State/province [32] 5615 0
Country [33] 5616 0
Singapore
State/province [33] 5616 0
Country [34] 5617 0
New Zealand
State/province [34] 5617 0

Funding & Sponsors
Funding source category [1] 2527 0
Other Collaborative groups
Name [1] 2527 0
European Organisation for Research and Tretment of Cancer (EORTC)
Country [1] 2527 0
Belgium
Primary sponsor type
Other Collaborative groups
Name
European Organisation for Research and Tretment of Cancer (EORTC)
Address
Avenue Mounierlaan, 83/11 Brussel 1200 Bruxelles
Country
Belgium
Secondary sponsor category [1] 2180 0
Other Collaborative groups
Name [1] 2180 0
Trans Tasman Radiation Oncology Group (TROG)
Address [1] 2180 0
Edith St Waratah NSW 2298
Country [1] 2180 0
Australia
Other collaborator category [1] 277697 0
Other Collaborative groups
Name [1] 277697 0
National Cancer Institute of Canada – Clinical Trials Group (NCIC CTG)
Address [1] 277697 0
10 Stewart St
Kingston, ON,
K7L 3N6
Country [1] 277697 0
Canada
Other collaborator category [2] 277698 0
Other Collaborative groups
Name [2] 277698 0
Medical Research Council – National Cancer Research Institute (MRC-NCRI)
Address [2] 277698 0
One Kemble Street, London WC2B 4AN
Country [2] 277698 0
United Kingdom
Other collaborator category [3] 277699 0
Other Collaborative groups
Name [3] 277699 0
National Cancer Institute of Canada – Clinical Trials Group (NCIC CTG)
Address [3] 277699 0
10 Stewart St
Kingston, ON,
K7L 3N6
Country [3] 277699 0
Canada
Other collaborator category [4] 277700 0
Other Collaborative groups
Name [4] 277700 0
Medical Research Council – National Cancer Research Institute (MRC-NCRI)
Address [4] 277700 0
One Kemble Street, London WC2B 4AN
Country [4] 277700 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4236 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 4236 0
Ethics committee country [1] 4236 0
Australia
Date submitted for ethics approval [1] 4236 0
Approval date [1] 4236 0
30/08/2006
Ethics approval number [1] 4236 0
Ethics committee name [2] 4237 0
Christchurch Hospital
Ethics committee address [2] 4237 0
Ethics committee country [2] 4237 0
Australia
Date submitted for ethics approval [2] 4237 0
Approval date [2] 4237 0
Ethics approval number [2] 4237 0
Ethics committee name [3] 4442 0
Royal North Shore Hospital
Ethics committee address [3] 4442 0
Ethics committee country [3] 4442 0
Australia
Date submitted for ethics approval [3] 4442 0
Approval date [3] 4442 0
Ethics approval number [3] 4442 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27810 0
Dr Brigitta Baumert
Address 27810 0
Maastricht University Medical Center
P.O. Box 616
6200 MD Maastricht
Country 27810 0
Netherlands
Phone 27810 0
+31 45 5771200
Fax 27810 0
Email 27810 0
brigitta.baumert@maastro.nl
Contact person for public queries
Name 10896 0
Courtney Wheeler
Address 10896 0
PO Box 88, Waratah NSW 2298 Australia
Country 10896 0
Australia
Phone 10896 0
+61 240143911
Fax 10896 0
+61 2 401 43902
Email 10896 0
courtney.wheeler@trog.com.au
Contact person for scientific queries
Name 1824 0
Claire Phillips
Address 1824 0
Peter MacCallum Cancer Centre 305 Grattan Street, Melbourne
Country 1824 0
Australia
Phone 1824 0
+61 3 855 97984
Fax 1824 0
+61 3 9656 1424
Email 1824 0
claire.phillips@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes https://www.eortc.org/bibliography/#study=1083

Documents added automatically
No additional documents have been identified.