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Brain and Central Nervous System TumorsPhase 3NCT00182819

Radiation Therapy or Temozolomide in Treating Patients With Gliomas

A Phase 3 study testing temozolomide and radiation therapy in people with Brain and Central Nervous System Tumors, run by European Organisation for Research and Treatment of Cancer - EORTC at 89 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
temozolomide and radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
709 participants
Where
89 sitesin 19 countries
Study dates
Jul 2005to May 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

89 sites in 19 countries.

89 sites in 19 countries

United Kingdom15 sites

  • Clatterbridge Centre for Oncology

    Bebington, Wirral, England, CH63 4JY

  • University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre

    Bristol, Avon, BS2 8ED

  • Addenbrooke's Hospital

    Cambridge, England, CB2 0QQ

  • Gloucestershire Hospital NHS Foundation Trust - Cheltenham General Hospital

    Cheltenham, GL53 7AN

  • Western General Hospital

    Edinburgh, EH4 2XU

  • Leeds Cancer Centre at St. James's University Hospital

    Leeds, England, LS9 7TF

  • University College Hospital

    London, England, NW1 2PG

  • Royal Marsden - London

    London, England, SW3 6JJ

  • Royal Free Hospital

    London, NW3 2QG

  • Christie Hospital

    Manchester, England, M20 4BX

  • James Cook University Hospital

    Middlesbrough, England, TS4 3BW

  • Oxford University Hospitals NHS Trust - Churchill Hospital

    Oxford, OX3 7LE

  • Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital

    Preston, PR2 9HT

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England, S10 2SJ

  • Royal Marsden - Surrey

    Sutton, England, SM2 5PT

Other trials in United Kingdom

Australia12 sites

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4029

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102

  • Peter MacCallum Cancer Centre

    East Melbourne, Victoria, 3002

  • Austin and Repatriation Medical Centre

    Heidelberg West, Victoria, 3084

  • Liverpool Hospital

    Liverpool, BC NSW 1871

  • Sir Charles Gairdner Hospital - Nedlands

    Nedlands, Western Australia, 6009

  • Alfred Hospital

    Prahran, Victoria, 3181

  • Prince of Wales Private Hospital

    Randwick, New South Wales, 2031

  • Mater Adult Hospital

    South Brisbane, Queensland, 4101

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Sydney Cancer Centre at Royal Prince Alfred Hospital

    Sydney, New South Wales, 2050

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

Other trials in Australia

Canada12 sites

  • Tom Baker Cancer Centre - Calgary

    Calgary, Alberta, T2N 4N2

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • London Regional Cancer Program at London Health Sciences Centre

    London, Ontario, N6A 4L6

  • Hopital Notre-Dame du CHUM

    Montreal, Quebec, H2L 4M1

  • Mcgill University Health Centre - Gerald Bronfman Centre - Dept Of Oncology

    Montreal, Quebec, H2W 1S6

  • Allan Blair Cancer Centre at Pasqua Hospital

    Regina, Saskatchewan, S4T 7T1

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Edmond Odette Cancer Centre at Sunnybrook

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • BC Cancer Agency

    Vancouver, V5Z4E9

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

France10 sites

  • CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre

    Bordeaux, 33075

  • Institut Bergonie

    Bordeaux, 33076

  • CHU de Grenoble - Hopital de la Tronche

    Grenoble, 38043

  • CHU de la Timone

    Marseille, 13385

  • Centre Regional Rene Gauducheau

    Nantes-Saint Herblain, 44805

  • Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere

    Paris, 75651

  • Centre Eugene Marquis

    Rennes, 35042

  • Centre Paul Strauss

    Strasbourg, 67085

  • Institut Claudius Regaud

    Toulouse, 31059

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

Netherlands8 sites

  • Vrije Universiteit Medisch Centrum

    Amsterdam, 1007MB

  • Academisch Medisch Centrum - Universiteit van Amsterdam

    Amsterdam, 1105 AZ

  • University Medical Center Groningen

    Groningen, 9713 GZ

  • Maastro Clinic - Maastricht Radiation Oncology

    Maastricht, 6201 BN

  • Radboud University Medical Center Nijmegen

    Nijmegen, 6500 HB

  • Erasmus MC Cancer Institute - location Daniel den Hoed

    Rotterdam, 3008 AE

  • Medisch Centrum Haaglanden - Westeinde

    The Hague, 2501 CK

  • Dr. Bernard Verbeeten Instituut

    Tilburg, 5042 SB

Other trials in Netherlands

Spain6 sites

  • ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)

    Badalona - (Barcelona), 08916

  • Hospital General Vall D'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Clinico Universitario de Barcelona

    Barcelona, 08036

  • ICO Girona - Hospital Doctor Josep Trueta (Institut Catala D'Oncologia)

    Girona, 17007

  • ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)

    L'Hospitalet de Llobregat, 08907

Other trials in Spain

Germany4 sites

  • Universitatsklinikum Heidelberg

    Heidelberg, D-69120

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

  • Universitaetskliniken Regensburg

    Regensburg, 93053

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

Other trials in Germany

Italy4 sites

  • Ospedale Bellaria

    Bologna, I-40139

  • Ospedale San Raffaele

    Milan, 20132

  • Istituto Regina Elena / Istituti Fisioterapici Ospitalieri

    Roma, 00144

  • Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

    Turin, 10126

Other trials in Italy

Sweden4 sites

  • University Hospital of Linkoping

    Linköping, S-581 85

  • Skane University Hospital

    Lund, SE-22185

  • Umea Universitet

    Umeå, SE-901 87

  • Uppsala University Hospital

    Uppsala, SE-75185

Other trials in Sweden

Belgium3 sites

  • Hopital Universitaire Erasme

    Brussels, 1070

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

  • U.Z. Leuven - Campus Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Switzerland3 sites

  • Oncology Institute of Southern Switzerland - Ospedale Regionale Bellinzona e Valli

    Bellinzona, 6500

  • Centre Hospitalier Universitaire Vaudois - Lausanne

    Lausanne, 1011

  • UniversitaetsSpital Zurich

    Zurich, 8091

Other trials in Switzerland

Austria1 site

  • Medical University Vienna - General Hospital AKH

    Vienna, 1090

Other trials in Austria

Egypt1 site

  • National Cancer Institute of Egypt

    Cairo

Other trials in Egypt

Hungary1 site

  • National Institute Of Neurosurgery

    Budapest, 1145

Other trials in Hungary

Israel1 site

  • Rambam Health Care Campus, Oncology Institute

    Haifa, 31096

Other trials in Israel

Luxembourg1 site

  • Centre Francois Baclesse

    Esch / Alzette, 4240

Other trials in Luxembourg

New Zealand1 site

  • Canterbury Health Laboratories

    Christchurch

Other trials in New Zealand

Portugal1 site

  • Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA

    Lisbon, 1099-023 Codex

Other trials in Portugal

Singapore1 site

  • National University of Singapore

    Singapore, 119228

Other trials in Singapore

About this study

Official title: Primary Chemotherapy With Temozolomide Versus Radiotherapy in Patients With Low Grade Gliomas After Stratification for Genetic 1p Loss: A Phase III Study

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.

Read the 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.

Being tested
temozolomide, radiation therapy
Keywords
adult oligodendroglioma, adult diffuse astrocytoma, adult mixed glioma
Medical subject headings
Central Nervous System Neoplasms, Oligodendroglioma, Astrocytoma, Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • temozolomideDrug

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

  • radiation therapyRadiation

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

Study groups in NCT00182819
Study groupRoleWhat they receive
radiotherapyOtherRadiotherapy (control arm), 50.4 Gy, standard fractionation (28 x 1.8 Gy), conformal techniques
Receives: Radiation: radiation therapy
TemozolomideExperimentalTemozolomide 75 mg/m2 daily x 21 days, q 28 days until progression or for max. 12 cycles (experimental arm)
Receives: Drug: temozolomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    Measured: 5 years

Secondary outcomes (4)

  1. Overall survival

    Measured: 5 years

  2. Quality of life as measured by QLQ-C30 v3.0 and EORTC BN-20

    Measured: every 3 months until progression, and then every 6 months until death

  3. Mini-Mental State Examination

    Measured: every 3 months until progression, and then every 6 months until death

  4. Adverse events as measured by CTCAE v3.0

    Measured: As indicated in the protocol

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionAug 2013
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
709 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00182819
Sponsor's protocol ID
EORTC-22033-26033
Other IDs
2004-002714-11, CAN-NCIC-CE5, TROG 06.01, MRC-BR13, 2004
Status last verified
Oct 2016
First submitted
15 Sep 2005
Last updated
12 Oct 2016
Results posted
No

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.

    PubMed 20378192

  • 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.

    PubMed 22560713

  • 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.

    PubMed 29571083

  • 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.

    PubMed 27686946

  • 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.

    PubMed 27686943

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing temozolomide and radiation therapy in people with Brain and Central Nervous System Tumors, run by European Organisation for Research and Treatment of Cancer - EORTC at 89 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United Kingdom, Australia, Canada, France, Netherlands and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00182819, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2016.

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