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Radiation Therapy or Temozolomide in Treating Patients With Gliomas

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
temozolomide
radiation therapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult oligodendroglioma, adult diffuse astrocytoma, adult mixed glioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prince of Wales Private Hospital
  • Royal North Shore Hospital
  • Sydney Cancer Centre at Royal Prince Alfred Hospital
  • Calvary Mater Newcastle
  • Royal Brisbane and Women's Hospital
  • Princess Alexandra Hospital
  • Mater Adult Hospital
  • Peter MacCallum Cancer Centre
  • Austin and Repatriation Medical Centre
  • Alfred Hospital
  • Sir Charles Gairdner Hospital - Nedlands
  • Liverpool Hospital
  • Medical University Vienna - General Hospital AKH
  • Hopital Universitaire Erasme
  • Universitair Ziekenhuis Brussel
  • U.Z. Leuven - Campus Gasthuisberg
  • Tom Baker Cancer Centre - Calgary
  • CancerCare Manitoba
  • Saint John Regional Hospital
  • Nova Scotia Cancer Centre
  • Margaret and Charles Juravinski Cancer Centre
  • London Regional Cancer Program at London Health Sciences Centre
  • Edmond Odette Cancer Centre at Sunnybrook
  • Princess Margaret Hospital
  • Hopital Notre-Dame du CHUM
  • Mcgill University Health Centre - Gerald Bronfman Centre - Dept Of Oncology
  • Allan Blair Cancer Centre at Pasqua Hospital
  • BC Cancer Agency
  • National Cancer Institute of Egypt
  • CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre
  • Institut Bergonie
  • CHU de Grenoble - Hopital de la Tronche
  • CHU de la Timone
  • Centre Regional Rene Gauducheau
  • Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere
  • Centre Eugene Marquis
  • Centre Paul Strauss
  • Institut Claudius Regaud
  • Gustave Roussy
  • Universitatsklinikum Heidelberg
  • Universitaetsklinikum Leipzig
  • Universitaetskliniken Regensburg
  • Universitaetsklinikum Tuebingen
  • National Institute Of Neurosurgery
  • Rambam Health Care Campus, Oncology Institute
  • Ospedale Bellaria
  • Ospedale San Raffaele
  • Istituto Regina Elena / Istituti Fisioterapici Ospitalieri
  • Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
  • Centre Francois Baclesse
  • Vrije Universiteit Medisch Centrum
  • Academisch Medisch Centrum - Universiteit van Amsterdam
  • Medisch Centrum Haaglanden - Westeinde
  • University Medical Center Groningen
  • Maastro Clinic - Maastricht Radiation Oncology
  • Radboud University Medical Center Nijmegen
  • Erasmus MC Cancer Institute - location Daniel den Hoed
  • Dr. Bernard Verbeeten Instituut
  • Canterbury Health Laboratories
  • Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA
  • National University of Singapore
  • ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)
  • Hospital General Vall D'Hebron
  • Hospital Clinic de Barcelona
  • Hospital Clinico Universitario de Barcelona
  • ICO Girona - Hospital Doctor Josep Trueta (Institut Catala D'Oncologia)
  • ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)
  • University Hospital of Linkoping
  • Skane University Hospital
  • Umea Universitet
  • Uppsala University Hospital
  • Oncology Institute of Southern Switzerland - Ospedale Regionale Bellinzona e Valli
  • Centre Hospitalier Universitaire Vaudois - Lausanne
  • UniversitaetsSpital Zurich
  • University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
  • Clatterbridge Centre for Oncology
  • Addenbrooke's Hospital
  • Leeds Cancer Centre at St. James's University Hospital
  • University College Hospital
  • Royal Marsden - London
  • Christie Hospital
  • James Cook University Hospital
  • Cancer Research Centre at Weston Park Hospital
  • Royal Marsden - Surrey
  • Gloucestershire Hospital NHS Foundation Trust - Cheltenham General Hospital
  • Western General Hospital
  • Royal Free Hospital
  • Oxford University Hospitals NHS Trust - Churchill Hospital
  • Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

radiotherapy

Temozolomide

Arm Description

Radiotherapy (control arm), 50.4 Gy, standard fractionation (28 x 1.8 Gy), conformal techniques

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

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Overall survival
Quality of life as measured by QLQ-C30 v3.0 and EORTC BN-20
Mini-Mental State Examination
Adverse events as measured by CTCAE v3.0

Full Information

First Posted
September 15, 2005
Last Updated
October 11, 2016
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Collaborators
NCIC Clinical Trials Group, British Medical Research Council, Trans Tasman Radiation Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT00182819
Brief Title
Radiation Therapy or Temozolomide in Treating Patients With Gliomas
Official Title
Primary Chemotherapy With Temozolomide Versus Radiotherapy in Patients With Low Grade Gliomas After Stratification for Genetic 1p Loss: A Phase III Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Collaborators
NCIC Clinical Trials Group, British Medical Research Council, Trans Tasman Radiation Oncology Group

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult oligodendroglioma, adult diffuse astrocytoma, adult mixed glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
709 (Actual)

8. Arms, Groups, and Interventions

Arm Title
radiotherapy
Arm Type
Other
Arm Description
Radiotherapy (control arm), 50.4 Gy, standard fractionation (28 x 1.8 Gy), conformal techniques
Arm Title
Temozolomide
Arm Type
Experimental
Arm Description
Temozolomide 75 mg/m2 daily x 21 days, q 28 days until progression or for max. 12 cycles (experimental arm)
Intervention Type
Drug
Intervention Name(s)
temozolomide
Intervention Description
Temozolomide 75 mg/m2 daily x 21 days, q 28 days until progression or for max. 12 cycles
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
50.4 Gy, standard fractionation (28 x 1.8 Gy), conformal techniques
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
5 years
Title
Quality of life as measured by QLQ-C30 v3.0 and EORTC BN-20
Time Frame
every 3 months until progression, and then every 6 months until death
Title
Mini-Mental State Examination
Time Frame
every 3 months until progression, and then every 6 months until death
Title
Adverse events as measured by CTCAE v3.0
Time Frame
As indicated in the protocol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitta Baumert, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Roger Stupp, MD
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Study Chair
Facility Information:
Facility Name
Prince of Wales Private Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Royal North Shore Hospital
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Sydney Cancer Centre at Royal Prince Alfred Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Mater Adult Hospital
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Austin and Repatriation Medical Centre
City
Heidelberg West
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Alfred Hospital
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Sir Charles Gairdner Hospital - Nedlands
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
ZIP/Postal Code
BC NSW 1871
Country
Australia
Facility Name
Medical University Vienna - General Hospital AKH
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Hopital Universitaire Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Universitair Ziekenhuis Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
U.Z. Leuven - Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Tom Baker Cancer Centre - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Nova Scotia Cancer Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Margaret and Charles Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
London Regional Cancer Program at London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Edmond Odette Cancer Centre at Sunnybrook
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hopital Notre-Dame du CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Mcgill University Health Centre - Gerald Bronfman Centre - Dept Of Oncology
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Allan Blair Cancer Centre at Pasqua Hospital
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
BC Cancer Agency
City
Vancouver
ZIP/Postal Code
V5Z4E9
Country
Canada
Facility Name
National Cancer Institute of Egypt
City
Cairo
Country
Egypt
Facility Name
CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU de Grenoble - Hopital de la Tronche
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Centre Regional Rene Gauducheau
City
Nantes-Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67085
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Universitatsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
D-69120
Country
Germany
Facility Name
Universitaetsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitaetskliniken Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
National Institute Of Neurosurgery
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Rambam Health Care Campus, Oncology Institute
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Ospedale Bellaria
City
Bologna
ZIP/Postal Code
I-40139
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Istituto Regina Elena / Istituti Fisioterapici Ospitalieri
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
City
Turin
ZIP/Postal Code
10126
Country
Italy
Facility Name
Centre Francois Baclesse
City
Esch / Alzette
ZIP/Postal Code
4240
Country
Luxembourg
Facility Name
Vrije Universiteit Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1007MB
Country
Netherlands
Facility Name
Academisch Medisch Centrum - Universiteit van Amsterdam
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Medisch Centrum Haaglanden - Westeinde
City
Den Haag
ZIP/Postal Code
2501 CK
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Maastro Clinic - Maastricht Radiation Oncology
City
Maastricht
ZIP/Postal Code
6201 BN
Country
Netherlands
Facility Name
Radboud University Medical Center Nijmegen
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Erasmus MC Cancer Institute - location Daniel den Hoed
City
Rotterdam
ZIP/Postal Code
3008 AE
Country
Netherlands
Facility Name
Dr. Bernard Verbeeten Instituut
City
Tilburg
ZIP/Postal Code
5042 SB
Country
Netherlands
Facility Name
Canterbury Health Laboratories
City
Christchurch
Country
New Zealand
Facility Name
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA
City
Lisbon
ZIP/Postal Code
1099-023 Codex
Country
Portugal
Facility Name
National University of Singapore
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)
City
Badalona - (Barcelona)
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital General Vall D'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Clinico Universitario de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
ICO Girona - Hospital Doctor Josep Trueta (Institut Catala D'Oncologia)
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
University Hospital of Linkoping
City
Linkoping
ZIP/Postal Code
S-581 85
Country
Sweden
Facility Name
Skane University Hospital
City
Lund
ZIP/Postal Code
SE-22185
Country
Sweden
Facility Name
Umea Universitet
City
Umea
ZIP/Postal Code
SE-901 87
Country
Sweden
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
SE-75185
Country
Sweden
Facility Name
Oncology Institute of Southern Switzerland - Ospedale Regionale Bellinzona e Valli
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois - Lausanne
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
UniversitaetsSpital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
City
Bristol
State/Province
Avon
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology
City
Bebington, Wirral
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
University College Hospital
City
London
State/Province
England
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Royal Marsden - London
City
London
State/Province
England
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
James Cook University Hospital
City
Middlesbrough
State/Province
England
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Cancer Research Centre at Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Facility Name
Royal Marsden - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Gloucestershire Hospital NHS Foundation Trust - Cheltenham General Hospital
City
Cheltenham
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Trust - Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
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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.
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Radiation Therapy or Temozolomide in Treating Patients With Gliomas

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