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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00182819




Registration number
NCT00182819
Ethics application status
Date submitted
15/09/2005
Date registered
16/09/2005
Date last updated
12/10/2016

Titles & IDs
Public title
Radiation Therapy or Temozolomide in Treating Patients With Gliomas
Scientific title
Primary Chemotherapy With Temozolomide Versus Radiotherapy in Patients With Low Grade Gliomas After Stratification for Genetic 1p Loss: A Phase III Study
Secondary ID [1] 0 0
2004-002714-11
Secondary ID [2] 0 0
EORTC-22033-26033
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain and Central Nervous System Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Children's - Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - temozolomide
Treatment: Other - radiation therapy

Other: radiotherapy - Radiotherapy (control arm), 50.4 Gy, standard fractionation (28 x 1.8 Gy), conformal techniques

Experimental: Temozolomide - Temozolomide 75 mg/m2 daily x 21 days, q 28 days until progression or for max. 12 cycles (experimental arm)


Treatment: Drugs: temozolomide
Temozolomide 75 mg/m2 daily x 21 days, q 28 days until progression or for max. 12 cycles

Treatment: Other: radiation therapy
50.4 Gy, standard fractionation (28 x 1.8 Gy), conformal techniques
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
Quality of life as measured by QLQ-C30 v3.0 and EORTC BN-20
Timepoint [2] 0 0
every 3 months until progression, and then every 6 months until death
Secondary outcome [3] 0 0
Mini-Mental State Examination
Timepoint [3] 0 0
every 3 months until progression, and then every 6 months until death
Secondary outcome [4] 0 0
Adverse events as measured by CTCAE v3.0
Timepoint [4] 0 0
As indicated in the protocol

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Histologically confirmed low-grade glioma, including any of the following types:

* Astrocytoma (gemistocytic, fibrillary, or protoplasmatic)
* Oligoastrocytoma
* Oligodendroglioma
* WHO grade II disease
* Supratentorial tumor location only
* RTOG neurological function 0-3
* Not a candidate for surgical treatment alone
* Requires treatment, as determined by = 1 of the following criteria:

* Age = 40 years
* Radiologically-proven progressive lesion
* New or worsening neurological symptoms other than seizures only (e.g., focal deficits, signs of increased intracranial pressure, or mental deficits)
* Intractable seizures, defined by both of the following criteria:

* Experiences persistent seizures that interfere with everyday life activities except driving a car
* Failed 3 anti-epileptic drug regimens, including = 1 combination regimen
* Tumor material (paraffin-embedded) or histopathologic slides available

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* WHO 0-2

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count = 1,500/mm^3
* Platelet count = 100,000/mm^3

Hepatic

* No chronic hepatitis B or C infection
* Bilirubin = 1.5 times upper limit of normal (ULN)
* AST or ALT = 2.5 times ULN
* Alkaline phosphatase = 2.5 times ULN

Renal

* Creatinine = 1.5 times ULN

Other

* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 6 months after completion of study treatment
* No known HIV positivity
* No other serious medical condition
* No other prior or concurrent malignancy except surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer
* No psychological, familial, sociological, or geographical condition that would preclude study participation
* No medical condition that would preclude receiving oral medication (e.g., frequent vomiting or partial bowel obstruction)

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No concurrent growth factors for elevating absolute neutrophil counts for the purpose of temozolomide administration
* No concurrent epoetin alfa
* No concurrent immunotherapy or biologic therapy

Chemotherapy

* No prior chemotherapy
* No other concurrent chemotherapy, including adjuvant chemotherapy for patients randomized to undergo radiotherapy

Endocrine therapy

* Not specified

Radiotherapy

* No prior radiotherapy to the brain
* No concurrent integrated boost with intensity-modulated radiotherapy

Surgery

* Recovered from prior surgery
* No concurrent surgical tumor debulking

Other

* No prior randomization to this study
* No other concurrent investigational drugs
* No concurrent regular use of agents known to be radiosensitizers or radioprotectors (e.g., cyclooxygenase-2 inhibitors, thalidomide, or amifostine) during study radiotherapy

* Occasional use of nonsteroidal anti-inflammatory drugs for pain allowed
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2014
Sample size
Target
Accrual to date
Final
709
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [3] 0 0
Sydney Cancer Centre at Royal Prince Alfred Hospital - Sydney
Recruitment hospital [4] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [5] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [7] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [8] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [9] 0 0
Austin and Repatriation Medical Centre - Heidelberg West
Recruitment hospital [10] 0 0
Alfred Hospital - Prahran
Recruitment hospital [11] 0 0
Sir Charles Gairdner Hospital - Nedlands - Nedlands
Recruitment hospital [12] 0 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment postcode(s) [3] 0 0
2050 - Sydney
Recruitment postcode(s) [4] 0 0
2298 - Waratah
Recruitment postcode(s) [5] 0 0
4029 - Brisbane
Recruitment postcode(s) [6] 0 0
4102 - Brisbane
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment postcode(s) [8] 0 0
3002 - East Melbourne
Recruitment postcode(s) [9] 0 0
3084 - Heidelberg West
Recruitment postcode(s) [10] 0 0
3181 - Prahran
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment postcode(s) [12] 0 0
BC NSW 1871 - Liverpool
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Belgium
State/province [3] 0 0
Leuven
Country [4] 0 0
Canada
State/province [4] 0 0
Alberta
Country [5] 0 0
Canada
State/province [5] 0 0
Manitoba
Country [6] 0 0
Canada
State/province [6] 0 0
New Brunswick
Country [7] 0 0
Canada
State/province [7] 0 0
Nova Scotia
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Canada
State/province [10] 0 0
Saskatchewan
Country [11] 0 0
Canada
State/province [11] 0 0
Vancouver
Country [12] 0 0
Egypt
State/province [12] 0 0
Cairo
Country [13] 0 0
France
State/province [13] 0 0
Bordeaux
Country [14] 0 0
France
State/province [14] 0 0
Grenoble
Country [15] 0 0
France
State/province [15] 0 0
Marseille
Country [16] 0 0
France
State/province [16] 0 0
Nantes-Saint Herblain
Country [17] 0 0
France
State/province [17] 0 0
Paris
Country [18] 0 0
France
State/province [18] 0 0
Rennes
Country [19] 0 0
France
State/province [19] 0 0
Strasbourg
Country [20] 0 0
France
State/province [20] 0 0
Toulouse
Country [21] 0 0
France
State/province [21] 0 0
Villejuif
Country [22] 0 0
Germany
State/province [22] 0 0
Heidelberg
Country [23] 0 0
Germany
State/province [23] 0 0
Leipzig
Country [24] 0 0
Germany
State/province [24] 0 0
Regensburg
Country [25] 0 0
Germany
State/province [25] 0 0
Tuebingen
Country [26] 0 0
Hungary
State/province [26] 0 0
Budapest
Country [27] 0 0
Israel
State/province [27] 0 0
Haifa
Country [28] 0 0
Italy
State/province [28] 0 0
Bologna
Country [29] 0 0
Italy
State/province [29] 0 0
Milano
Country [30] 0 0
Italy
State/province [30] 0 0
Roma
Country [31] 0 0
Italy
State/province [31] 0 0
Turin
Country [32] 0 0
Luxembourg
State/province [32] 0 0
Esch / Alzette
Country [33] 0 0
Netherlands
State/province [33] 0 0
Amsterdam
Country [34] 0 0
Netherlands
State/province [34] 0 0
Den Haag
Country [35] 0 0
Netherlands
State/province [35] 0 0
Groningen
Country [36] 0 0
Netherlands
State/province [36] 0 0
Maastricht
Country [37] 0 0
Netherlands
State/province [37] 0 0
Nijmegen
Country [38] 0 0
Netherlands
State/province [38] 0 0
Rotterdam
Country [39] 0 0
Netherlands
State/province [39] 0 0
Tilburg
Country [40] 0 0
New Zealand
State/province [40] 0 0
Christchurch
Country [41] 0 0
Portugal
State/province [41] 0 0
Lisbon
Country [42] 0 0
Singapore
State/province [42] 0 0
Singapore
Country [43] 0 0
Spain
State/province [43] 0 0
Badalona - (Barcelona)
Country [44] 0 0
Spain
State/province [44] 0 0
Barcelona
Country [45] 0 0
Spain
State/province [45] 0 0
Girona
Country [46] 0 0
Spain
State/province [46] 0 0
L'Hospitalet de Llobregat
Country [47] 0 0
Sweden
State/province [47] 0 0
Linkoping
Country [48] 0 0
Sweden
State/province [48] 0 0
Lund
Country [49] 0 0
Sweden
State/province [49] 0 0
Umea
Country [50] 0 0
Sweden
State/province [50] 0 0
Uppsala
Country [51] 0 0
Switzerland
State/province [51] 0 0
Bellinzona
Country [52] 0 0
Switzerland
State/province [52] 0 0
Lausanne
Country [53] 0 0
Switzerland
State/province [53] 0 0
Zurich
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Avon
Country [55] 0 0
United Kingdom
State/province [55] 0 0
England
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Cheltenham
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Edinburgh
Country [58] 0 0
United Kingdom
State/province [58] 0 0
London
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Oxford
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Preston

Funding & Sponsors
Primary sponsor type
Other
Name
European Organisation for Research and Treatment of Cancer - EORTC
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
NCIC Clinical Trials Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
British Medical Research Council
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Trans Tasman Radiation Oncology Group
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Brigitta Baumert, MD, PhD
Address 0 0
Maastricht University Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00182819