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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
Primary Chemotherapy With Temozolomide Versus Radiotherapy in Patients With Low Grade Gliomas After Stratification for Genetic 1p Loss: A Phase III Study
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Secondary ID [1]
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2004-002714-11
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Secondary ID [2]
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EORTC-22033-26033
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Brain and Central Nervous System Tumors
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Condition category
Condition code
Cancer
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Brain
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Cancer
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Neuroendocrine tumour (NET)
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Cancer
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Children's - Brain
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free survival
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Assessment method [1]
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Timepoint [1]
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5 years
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Secondary outcome [1]
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Overall survival
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Assessment method [1]
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Timepoint [1]
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5 years
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Secondary outcome [2]
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Quality of life as measured by QLQ-C30 v3.0 and EORTC BN-20
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Assessment method [2]
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Timepoint [2]
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every 3 months until progression, and then every 6 months until death
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Secondary outcome [3]
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Mini-Mental State Examination
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Assessment method [3]
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Timepoint [3]
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every 3 months until progression, and then every 6 months until death
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Secondary outcome [4]
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Adverse events as measured by CTCAE v3.0
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Assessment method [4]
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Timepoint [4]
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As indicated in the protocol
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2014
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Sample size
Target
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Accrual to date
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Final
709
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Prince of Wales Private Hospital - Randwick
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Royal North Shore Hospital - St. Leonards
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Sydney Cancer Centre at Royal Prince Alfred Hospital - Sydney
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Calvary Mater Newcastle - Waratah
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Royal Brisbane and Women's Hospital - Brisbane
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Princess Alexandra Hospital - Brisbane
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Mater Adult Hospital - South Brisbane
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Peter MacCallum Cancer Centre - East Melbourne
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Austin and Repatriation Medical Centre - Heidelberg West
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Alfred Hospital - Prahran
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Sir Charles Gairdner Hospital - Nedlands - Nedlands
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Liverpool Hospital - Liverpool
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2031 - Randwick
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2065 - St. Leonards
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2050 - Sydney
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2298 - Waratah
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4029 - Brisbane
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Recruitment postcode(s) [6]
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4102 - Brisbane
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4101 - South Brisbane
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3002 - East Melbourne
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3084 - Heidelberg West
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3181 - Prahran
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6009 - Nedlands
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Recruitment postcode(s) [12]
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BC NSW 1871 - Liverpool
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Recruitment outside Australia
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Austria
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Vienna
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Belgium
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Brussels
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Belgium
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Leuven
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London
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Oxford
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Preston
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Funding & Sponsors
Primary sponsor type
Other
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Name
European Organisation for Research and Treatment of Cancer - EORTC
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Address
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Other
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NCIC Clinical Trials Group
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Other
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British Medical Research Council
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Other
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Trans Tasman Radiation Oncology Group
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Ethics approval
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Summary
Brief summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in
chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells,
either by killing the cells or by stopping them from dividing. It is not yet known whether
radiation therapy is more effective than temozolomide in treating gliomas.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it
works compared to temozolomide in treating patients with gliomas.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00182819
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Trial related presentations / publications
Musat E, Roelofs E, Bar-Deroma R, Fenton P, Gulyban A, Collette L, Stupp R, Weber DC, Bernard Davis J, Aird E, Baumert BG. Dummy run and conformity indices in the ongoing EORTC low-grade glioma trial 22033-26033: First evaluation of quality of radiotherapy planning. Radiother Oncol. 2010 May;95(2):218-24. doi: 10.1016/j.radonc.2010.03.005. Epub 2010 Apr 6.
Fairchild A, Weber DC, Bar-Deroma R, Gulyban A, Fenton PA, Stupp R, Baumert BG. Quality assurance in the EORTC 22033-26033/CE5 phase III randomized trial for low grade glioma: the digital individual case review. Radiother Oncol. 2012 Jun;103(3):287-92. doi: 10.1016/j.radonc.2012.04.002. Epub 2012 May 3.
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Public notes
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Contacts
Principal investigator
Name
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Brigitta Baumert, MD, PhD
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Address
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Maastricht University Medical Center
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00182819
Download to PDF