Radiation Therapy or Temozolomide in Treating Patients With Gliomas
NCT ID: NCT00182819
Last Updated: 2016-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
709 participants
INTERVENTIONAL
2005-07-31
2014-05-31
Brief Summary
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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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Detailed Description
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Primary
* Compare the progression-free survival of patients with low-grade gliomas treated with radiotherapy vs temozolomide.
Secondary
* Compare the overall survival of patients treated with these regimens.
* Determine whether the incidence of late toxicity can be decreased in patients who are randomized to receive temozolomide.
* Compare the toxic effects of these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to participating center, chromosome 1p status (deleted vs normal vs undeterminable), contrast enhancement on MRI (yes vs no), age (\< 40 years vs ≥ 40 years), and WHO performance status (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo radiotherapy once daily, 5 days a week, for a total of 28 fractions (i.e., 5½ weeks).
* Arm II: Patients receive oral temozolomide once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 3 months until disease progression.
After completion of study treatment, patients are followed every 6 months for survival.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A minimum of 699 patients (a total of 466 randomized \[233 per treatment arm\]) will be accrued for this study within 5 years.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
NONE
Study Groups
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radiotherapy
Radiotherapy (control arm), 50.4 Gy, standard fractionation (28 x 1.8 Gy), conformal techniques
radiation therapy
50.4 Gy, standard fractionation (28 x 1.8 Gy), conformal techniques
Temozolomide
Temozolomide 75 mg/m2 daily x 21 days, q 28 days until progression or for max. 12 cycles (experimental arm)
temozolomide
Temozolomide 75 mg/m2 daily x 21 days, q 28 days until progression or for max. 12 cycles
Interventions
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temozolomide
Temozolomide 75 mg/m2 daily x 21 days, q 28 days until progression or for max. 12 cycles
radiation therapy
50.4 Gy, standard fractionation (28 x 1.8 Gy), conformal techniques
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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NCIC Clinical Trials Group
NETWORK
British Medical Research Council
OTHER_GOV
Trans Tasman Radiation Oncology Group
OTHER
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Brigitta Baumert, MD, PhD
Role: STUDY_CHAIR
Maastricht University Medical Center
Roger Stupp, MD
Role: STUDY_CHAIR
Centre Hospitalier Universitaire Vaudois
Locations
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Prince of Wales Private Hospital
Randwick, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Mater Adult Hospital
South Brisbane, Queensland, Australia
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
Austin and Repatriation Medical Centre
Heidelberg West, Victoria, Australia
Alfred Hospital
Prahran, Victoria, Australia
Sir Charles Gairdner Hospital - Nedlands
Nedlands, Western Australia, Australia
Liverpool Hospital
Liverpool, , Australia
Medical University Vienna - General Hospital AKH
Vienna, , Austria
Hopital Universitaire Erasme
Brussels, , Belgium
Universitair Ziekenhuis Brussel
Brussels, , Belgium
U.Z. Leuven - Campus Gasthuisberg
Leuven, , Belgium
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada
Edmond Odette Cancer Centre at Sunnybrook
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada
Mcgill University Health Centre - Gerald Bronfman Centre - Dept Of Oncology
Montreal, Quebec, Canada
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada
BC Cancer Agency
Vancouver, , Canada
National Cancer Institute of Egypt
Cairo, , Egypt
CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre
Bordeaux, , France
Institut Bergonie
Bordeaux, , France
CHU de Grenoble - Hopital de la Tronche
Grenoble, , France
CHU de la Timone
Marseille, , France
Centre Regional Rene Gauducheau
Nantes-Saint Herblain, , France
Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere
Paris, , France
Centre Eugene Marquis
Rennes, , France
Centre Paul Strauss
Strasbourg, , France
Institut Claudius Regaud
Toulouse, , France
Gustave Roussy
Villejuif, , France
Universitatsklinikum Heidelberg
Heidelberg, , Germany
Universitaetsklinikum Leipzig
Leipzig, , Germany
Universitaetskliniken Regensburg
Regensburg, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
National Institute Of Neurosurgery
Budapest, , Hungary
Rambam Health Care Campus, Oncology Institute
Haifa, , Israel
Ospedale Bellaria
Bologna, , Italy
Ospedale San Raffaele
Milan, , Italy
Istituto Regina Elena / Istituti Fisioterapici Ospitalieri
Roma, , Italy
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
Turin, , Italy
Centre Francois Baclesse
Esch / Alzette, , Luxembourg
Vrije Universiteit Medisch Centrum
Amsterdam, , Netherlands
Academisch Medisch Centrum - Universiteit van Amsterdam
Amsterdam, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Maastro Clinic - Maastricht Radiation Oncology
Maastricht, , Netherlands
Radboud University Medical Center Nijmegen
Nijmegen, , Netherlands
Erasmus MC Cancer Institute - location Daniel den Hoed
Rotterdam, , Netherlands
Medisch Centrum Haaglanden - Westeinde
The Hague, , Netherlands
Dr. Bernard Verbeeten Instituut
Tilburg, , Netherlands
Canterbury Health Laboratories
Christchurch, , New Zealand
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA
Lisbon, , Portugal
National University of Singapore
Singapore, , Singapore
ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)
Badalona - (Barcelona), , Spain
Hospital General Vall D'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Clinico Universitario de Barcelona
Barcelona, , Spain
ICO Girona - Hospital Doctor Josep Trueta (Institut Catala D'Oncologia)
Girona, , Spain
ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)
L'Hospitalet de Llobregat, , Spain
University Hospital of Linkoping
Linköping, , Sweden
Skane University Hospital
Lund, , Sweden
Umea Universitet
Umeå, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Oncology Institute of Southern Switzerland - Ospedale Regionale Bellinzona e Valli
Bellinzona, , Switzerland
Centre Hospitalier Universitaire Vaudois - Lausanne
Lausanne, , Switzerland
UniversitaetsSpital Zurich
Zurich, , Switzerland
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
Bristol, Avon, United Kingdom
Clatterbridge Centre for Oncology
Bebington, Wirral, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
University College Hospital
London, England, United Kingdom
Royal Marsden - London
London, England, United Kingdom
Christie Hospital
Manchester, England, United Kingdom
James Cook University Hospital
Middlesbrough, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Gloucestershire Hospital NHS Foundation Trust - Cheltenham General Hospital
Cheltenham, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Oxford University Hospitals NHS Trust - Churchill Hospital
Oxford, , United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
Preston, , United Kingdom
Countries
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References
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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.
Gao Y, Weenink B, van den Bent MJ, Erdem-Eraslan L, Kros JM, Sillevis Smitt P, Hoang-Xuan K, Brandes AA, Vos M, Dhermain F, Enting R, Ryan GF, Chinot O, Ben Hassel M, van Linde ME, Mason WP, Gijtenbeek JMM, Balana C, von Deimling A, Gorlia T, Stupp R, Hegi ME, Baumert BG, French PJ. Expression-based intrinsic glioma subtypes are prognostic in low-grade gliomas of the EORTC22033-26033 clinical trial. Eur J Cancer. 2018 May;94:168-178. doi: 10.1016/j.ejca.2018.02.023. Epub 2018 Mar 20.
Baumert BG, Hegi ME, van den Bent MJ, von Deimling A, Gorlia T, Hoang-Xuan K, Brandes AA, Kantor G, Taphoorn MJB, Hassel MB, Hartmann C, Ryan G, Capper D, Kros JM, Kurscheid S, Wick W, Enting R, Reni M, Thiessen B, Dhermain F, Bromberg JE, Feuvret L, Reijneveld JC, Chinot O, Gijtenbeek JMM, Rossiter JP, Dif N, Balana C, Bravo-Marques J, Clement PM, Marosi C, Tzuk-Shina T, Nordal RA, Rees J, Lacombe D, Mason WP, Stupp R. Temozolomide chemotherapy versus radiotherapy in high-risk low-grade glioma (EORTC 22033-26033): a randomised, open-label, phase 3 intergroup study. Lancet Oncol. 2016 Nov;17(11):1521-1532. doi: 10.1016/S1470-2045(16)30313-8. Epub 2016 Sep 27.
Reijneveld JC, Taphoorn MJB, Coens C, Bromberg JEC, Mason WP, Hoang-Xuan K, Ryan G, Hassel MB, Enting RH, Brandes AA, Wick A, Chinot O, Reni M, Kantor G, Thiessen B, Klein M, Verger E, Borchers C, Hau P, Back M, Smits A, Golfinopoulos V, Gorlia T, Bottomley A, Stupp R, Baumert BG. Health-related quality of life in patients with high-risk low-grade glioma (EORTC 22033-26033): a randomised, open-label, phase 3 intergroup study. Lancet Oncol. 2016 Nov;17(11):1533-1542. doi: 10.1016/S1470-2045(16)30305-9. Epub 2016 Sep 27.
Other Identifiers
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2004-002714-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAN-NCIC-CE5
Identifier Type: -
Identifier Source: secondary_id
TROG 06.01
Identifier Type: -
Identifier Source: secondary_id
MRC-BR13
Identifier Type: -
Identifier Source: secondary_id
EORTC-22033-26033
Identifier Type: -
Identifier Source: org_study_id
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