Radiation Therapy or Temozolomide in Treating Patients With Gliomas
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- Radiation: radiation therapy
- Registration Number
- NCT00182819
- 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.
- Detailed Description
OBJECTIVES:
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 709
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description radiotherapy radiation therapy Radiotherapy (control arm), 50.4 Gy, standard fractionation (28 x 1.8 Gy), conformal techniques Temozolomide temozolomide Temozolomide 75 mg/m2 daily x 21 days, q 28 days until progression or for max. 12 cycles (experimental arm)
- Primary Outcome Measures
Name Time Method Progression-free survival 5 years
- Secondary Outcome Measures
Name Time Method Overall survival 5 years Adverse events as measured by CTCAE v3.0 As indicated in the protocol Quality of life as measured by QLQ-C30 v3.0 and EORTC BN-20 every 3 months until progression, and then every 6 months until death Mini-Mental State Examination every 3 months until progression, and then every 6 months until death
Trial Locations
- Locations (89)
Edmond Odette Cancer Centre at Sunnybrook
🇨🇦Toronto, Ontario, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Allan Blair Cancer Centre at Pasqua Hospital
🇨🇦Regina, Saskatchewan, Canada
University College Hospital
🇬🇧London, England, United Kingdom
Royal Marsden - London
🇬🇧London, England, United Kingdom
Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere
🇫🇷Paris, France
CHU de la Timone
🇫🇷Marseille, France
Centre Regional Rene Gauducheau
🇫🇷Nantes-Saint Herblain, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Centre Eugene Marquis
🇫🇷Rennes, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Gustave Roussy
🇫🇷Villejuif, France
Peter MacCallum Cancer Centre
🇦🇺East Melbourne, Victoria, Australia
Austin and Repatriation Medical Centre
🇦🇺Heidelberg West, Victoria, Australia
Liverpool Hospital
🇦🇺Liverpool, Australia
Prince of Wales Private Hospital
🇦🇺Randwick, New South Wales, Australia
Calvary Mater Newcastle
🇦🇺Waratah, New South Wales, Australia
Sydney Cancer Centre at Royal Prince Alfred Hospital
🇦🇺Sydney, New South Wales, Australia
Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Queensland, Australia
Mater Adult Hospital
🇦🇺South Brisbane, Queensland, Australia
Sir Charles Gairdner Hospital - Nedlands
🇦🇺Nedlands, Western Australia, 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
Margaret and Charles Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Tom Baker Cancer Centre - Calgary
🇨🇦Calgary, Alberta, Canada
London Regional Cancer Program at London Health Sciences Centre
🇨🇦London, Ontario, Canada
Hopital Notre-Dame du CHUM
🇨🇦Montreal, Quebec, Canada
University Hospital of Linkoping
🇸🇪Linkoping, Sweden
Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
🇬🇧Preston, United Kingdom
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
Universitaetskliniken Regensburg
🇩🇪Regensburg, Germany
Gloucestershire Hospital NHS Foundation Trust - Cheltenham General Hospital
🇬🇧Cheltenham, United Kingdom
Umea Universitet
🇸🇪Umea, Sweden
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
Uppsala University Hospital
🇸🇪Uppsala, Sweden
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Western General Hospital
🇬🇧Edinburgh, United Kingdom
Oxford University Hospitals NHS Trust - Churchill Hospital
🇬🇧Oxford, United Kingdom
Vrije Universiteit Medisch Centrum
🇳🇱Amsterdam, Netherlands
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Hospital General Vall D'Hebron
🇪🇸Barcelona, Spain
Erasmus MC Cancer Institute - location Daniel den Hoed
🇳🇱Rotterdam, Netherlands
Ospedale San Raffaele
🇮🇹Milano, Italy
Christie Hospital
🇬🇧Manchester, England, United Kingdom
Centre Hospitalier Universitaire Vaudois - Lausanne
🇨🇭Lausanne, Switzerland
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
🇬🇧Bristol, Avon, United Kingdom
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
UniversitaetsSpital Zurich
🇨🇭Zurich, Switzerland
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Medisch Centrum Haaglanden - Westeinde
🇳🇱Den Haag, Netherlands
Maastro Clinic - Maastricht Radiation Oncology
🇳🇱Maastricht, Netherlands
Radboud University Medical Center Nijmegen
🇳🇱Nijmegen, Netherlands
Dr. Bernard Verbeeten Instituut
🇳🇱Tilburg, Netherlands
Skane University Hospital
🇸🇪Lund, Sweden
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
National University of Singapore
🇸🇬Singapore, Singapore
Royal Free Hospital
🇬🇧London, United Kingdom
ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)
🇪🇸Badalona - (Barcelona), Spain
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Canterbury Health Laboratories
🇳🇿Christchurch, New Zealand
James Cook University Hospital
🇬🇧Middlesbrough, England, United Kingdom
Hospital Clinico Universitario de Barcelona
🇪🇸Barcelona, Spain
Centre Francois Baclesse
🇱🇺Esch / Alzette, Luxembourg
Royal North Shore Hospital
🇦🇺St. Leonards, New South Wales, Australia
Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, Australia
Universitatsklinikum Heidelberg
🇩🇪Heidelberg, Germany
BC Cancer Agency
🇨🇦Vancouver, Canada
Mcgill University Health Centre - Gerald Bronfman Centre - Dept Of Oncology
🇨🇦Montreal, Quebec, Canada
Universitaetsklinikum Leipzig
🇩🇪Leipzig, Germany
National Institute Of Neurosurgery
🇭🇺Budapest, Hungary
Ospedale Bellaria
🇮🇹Bologna, Italy
Rambam Health Care Campus, Oncology Institute
🇮🇱Haifa, Israel
Istituto Regina Elena / Istituti Fisioterapici Ospitalieri
🇮🇹Roma, Italy
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
🇮🇹Turin, Italy
Academisch Medisch Centrum - Universiteit van Amsterdam
🇳🇱Amsterdam, Netherlands
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA
🇵🇹Lisbon, Portugal
Oncology Institute of Southern Switzerland - Ospedale Regionale Bellinzona e Valli
🇨🇭Bellinzona, Switzerland
Clatterbridge Centre for Oncology
🇬🇧Bebington, Wirral, England, United Kingdom
Alfred Hospital
🇦🇺Prahran, Victoria, Australia
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Nova Scotia Cancer Centre
🇨🇦Halifax, Nova Scotia, Canada
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom