Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

• ClinicalTrials.gov Identifier: NCT00006353
• Recruitment Status: Completed
• First Posted: December 24, 2003
• Last Update Posted: September 24, 2012
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Collaborator: NCIC Clinical Trials Group
• Information provided by (Responsible Party): European Organisation for Research and Treatment of Cancer - EORTC

No Study Results Posted on ClinicalTrials.gov for this Study

• Recruitment Status: Completed
• Actual Primary Completion Date: March 2002
• Study Completion Date: No date given

Publications of Results:

Weller M, Gorlia T, Cairncross JG, van den Bent MJ, Mason W, Belanger K, Brandes AA, Bogdahn U, Macdonald DR, Forsyth P, Rossetti AO, Lacombe D, Mirimanoff RO, Vecht CJ, Stupp R. Prolonged survival with valproic acid use in the EORTC/NCIC temozolomide trial for glioblastoma. Neurology. 2011 Sep 20;77(12):1156-64. doi: 10.1212/WNL.0b013e31822f02e1. Epub 2011 Aug 31.

Stupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, Ludwin SK, Allgeier A, Fisher B, Belanger K, Hau P, Brandes AA, Gijtenbeek J, Marosi C, Vecht CJ, Mokhtari K, Wesseling P, Villa S, Eisenhauer E, Gorlia T, Weller M, Lacombe D, Cairncross JG, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups; National Cancer Institute of Canada Clinical Trials Group. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009 May;10(5):459-66. doi: 10.1016/S1470-2045(09)70025-7. Epub 2009 Mar 9.

Gorlia T, van den Bent MJ, Hegi ME, Mirimanoff RO, Weller M, Cairncross JG, Eisenhauer E, Belanger K, Brandes AA, Allgeier A, Lacombe D, Stupp R. Nomograms for predicting survival of patients with newly diagnosed glioblastoma: prognostic factor analysis of EORTC and NCIC trial 26981-22981/CE.3. Lancet Oncol. 2008 Jan;9(1):29-38. doi: 10.1016/S1470-2045(07)70384-4. Epub 2007 Dec 21.

Mauer M, Stupp R, Taphoorn MJ, Coens C, Osoba D, Marosi C, Wong R, de Witte O, Cairncross JG, Efficace F, Mirimanoff RO, Forsyth P, van den Bent MJ, Weller M, Bottomley A. The prognostic value of health-related quality-of-life data in predicting survival in glioblastoma cancer patients: results from an international randomised phase III EORTC Brain Tumour and Radiation Oncology Groups, and NCIC Clinical Trials Group study. Br J Cancer. 2007 Aug 6;97(3):302-7. doi: 10.1038/sj.bjc.6603876. Epub 2007 Jul 3.

Mirimanoff R, Mason W, van den Bent M, et al.: Is long-term survival in glioblastoma possible? Updated results of the EORTC/NCIC phase III randomized trial on radiotherapy (RT) and concomitant and adjuvant temozolomide (TMZ) versus RT alone. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): Plenary-3, S2, 2007.

Mirimanoff RO, Gorlia T, Mason W, Van den Bent MJ, Kortmann RD, Fisher B, Reni M, Brandes AA, Curschmann J, Villa S, Cairncross G, Allgeier A, Lacombe D, Stupp R. Radiotherapy and temozolomide for newly diagnosed glioblastoma: recursive partitioning analysis of the EORTC 26981/22981-NCIC CE3 phase III randomized trial. J Clin Oncol. 2006 Jun 1;24(16):2563-9. doi: 10.1200/JCO.2005.04.5963.

Bottomley A, Taphoorn M, Coens C, et al.: Predicting survival using health related quality of life scores in glioblastoma cancers: findings from an international phase III randomised controlled trial. [Abstract] J Clin Oncol 23 (Suppl 16): A-9601, 861s, 2005.

Cohen MH, Johnson JR, Pazdur R. Food and Drug Administration Drug approval summary: temozolomide plus radiation therapy for the treatment of newly diagnosed glioblastoma multiforme. Clin Cancer Res. 2005 Oct 1;11(19 Pt 1):6767-71. doi: 10.1158/1078-0432.CCR-05-0722.

Hegi ME, Diserens AC, Gorlia T, Hamou MF, de Tribolet N, Weller M, Kros JM, Hainfellner JA, Mason W, Mariani L, Bromberg JE, Hau P, Mirimanoff RO, Cairncross JG, Janzer RC, Stupp R. MGMT gene silencing and benefit from temozolomide in glioblastoma. N Engl J Med. 2005 Mar 10;352(10):997-1003. doi: 10.1056/NEJMoa043331.

Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.

Taphoorn MJ, Stupp R, Coens C, Osoba D, Kortmann R, van den Bent MJ, Mason W, Mirimanoff RO, Baumert BG, Eisenhauer E, Forsyth P, Bottomley A; European Organisation for Research and Treatment of Cancer Brain Tumour Group; EORTC Radiotherapy Group; National Cancer Institute of Canada Clinical Trials Group. Health-related quality of life in patients with glioblastoma: a randomised controlled trial. Lancet Oncol. 2005 Dec;6(12):937-44. doi: 10.1016/S1470-2045(05)70432-0.

Ataman F, Poortmans P, Stupp R, Fisher B, Mirimanoff RO. Quality assurance of the EORTC 26981/22981; NCIC CE3 intergroup trial on radiotherapy with or without temozolomide for newly-diagnosed glioblastoma multiforme: the individual case review. Eur J Cancer. 2004 Jul;40(11):1724-30. doi: 10.1016/j.ejca.2004.03.026.

Gorlia T, Stupp R, Eisenhauer EA, et al.: Clinical prognostic factors affecting survival in patients with newly diagnosed glioblastoma multiforme (GBM). [Abstract] J Clin Oncol 22 (Suppl 14): A-9599, 859s, 2004.

Hegi M, Diserens A, Hamou M, et al.: Temozolomide (TMZ) targets only glioblastoma with a silenced MGMT-gene. Results of a translational companion study to EORTC 26981/NCIC CE.3 or radiotherapy ± TMZ. [Abstract] Eur J Cancer 2 (8 Suppl 2): A-31, 14, 2004.

Mirimanoff RO, Mason W, Kortmann R, et al.: Radiotherapy (RT) and concomitant and adjuvant temozolomide (TMZ) versus radiotherapy alone for newly diagnosed glioblastoma (GBM): overall results and recursive partitioning analysis (RPA) of a phase III randomized trial of the EORTC Brain Tumor and Radiotherapy Group and the NCIC Clinical Trial Group. [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-55, S162, 2004. Available online. Last accessed January 26, 2005.

Murat A, Migliavacca E, Shay T, et al.: Gene expression profiling of human glioblastoma. A translational research study to the randomized trial EORTC 26981/NCIC CE.3 testing radiotherapy ± temozolomide. [Abstract] Eur J Cancer 2 (Suppl 8): A- 654, 197, 2004.

Stupp R, Mason WP, Van Den Bent MJ, et al.: Concomitant and adjuvant temozolomide (TMZ) and radiotherapy (RT) for newly diagnosed glioblastoma multiforme (GBM). Conclusive results of a randomized phase III trial by the EORTC Brain & RT Groups and NCIC Clinical Trials Group. [Abstract] J Clin Oncol 22 (Suppl 14): A-2, 1s, 2004.

Taphoorn MJ, Stupp R, Osoba D, et al.: An international phase III, randomized, controlled trial evaluating health-related quality of life in glioblastoma patients. [Abstract] Neuro-Oncology 6 (4): A-QL-13, 348, 2004.

Taphoorn MJ, Stupp R, Osoba D, et al.: Joint EORTC brain tumour group/radiotherapy group and NCIC CTG phase III randomized controlled trial evaluating health-related quality of life in glioblastoma patients . [Abstract] Ann Oncol 15 (3): A-7810, 2004.

Other Publications:

Linz U. Commentary on Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial (Lancet Oncol. 2009;10:459-466). Cancer. 2010 Apr 15;116(8):1844-6. doi: 10.1002/cncr.24950.

Lamers LM, Stupp R, van den Bent MJ, Al MJ, Gorlia T, Wasserfallen JB, Mittmann N, Jin Seung S, Crott R, Uyl-de Groot CA; EORTC 26981/22981 NCI-C CE3 Intergroup Study. Cost-effectiveness of temozolomide for the treatment of newly diagnosed glioblastoma multiforme: a report from the EORTC 26981/22981 NCI-C CE3 Intergroup Study. Cancer. 2008 Mar 15;112(6):1337-44. doi: 10.1002/cncr.23297.

Mason WP, Cairncross JG. Drug Insight: temozolomide as a treatment for malignant glioma--impact of a recent trial. Nat Clin Pract Neurol. 2005 Dec;1(2):88-95. doi: 10.1038/ncpneuro0045.