Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Alternate Title

Radiation Therapy in Treating Adult Patients With Brain Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	16 to 65		EORTC-22845 MRC-BR04

Objectives

I.  Compare the disease-free interval of adult patients with grade I/II 
astrocytoma, oligodendroglioma, or mixed astrocytoma/oligodendroglioma 
randomly assigned following surgery to radiotherapy vs. observation only until 
progression in institutions in which radiotherapy is not usually administered 
routinely for these patients.

II.  Compare the 2-, 3-, 5-, and 10-year survival and disease-free survival as 
well as performance status and quality of life in these two patient groups.

Entry Criteria

Disease Characteristics:

Biopsy-proven Grade I/II supratentorial astrocytoma, oligodendroglioma, or
mixed astrocytoma/oligodendroglioma following incomplete resection or biopsy

  Totally resected Grade II tumors also eligible

  Tumor histology and grade must be known from the local institution prior to
  randomization, and 12 unstained slides must be submitted to the review
  pathologist within 2 weeks of randomization

  Surgical procedure may vary from biopsy by craniotomy or stereotactic
  technique to total resection

     Entry within 4 to 8 weeks of surgery required

The following tumor types are not eligible:

  Ependymoma
  Optic
  Brainstem
  Hypothalamic
  Third ventricular
  Predominantly infratentorial gliomas
  Subependymal or pilocytic cerebral astrocytoma
  Very small, totally excised grade I tumors

  Grade I astrocytomas may be excluded at discretion of institution

Prior/Concurrent Therapy:

No prior therapy other than surgery, corticosteroids, anticonvulsants, and
diuretics

Patient Characteristics:

Age:
  16 to 65

Performance status:
  WHO 0-2

Hematopoietic:
  Not specified

Hepatic:
  No serious liver disease that would limit life span

Renal:
  No serious renal disease that would limit life span

Cardiovascular:
  No serious cardiovascular disease that would limit life span

Pulmonary:
  No serious respiratory disease that would limit life span

Other:
  No second malignancy except curable or cured nonmelanomatous skin cancer
  No pregnant women

Expected Enrollment

About 5 years will be necessary to accrue the required 100 patients per arm.

Outline

Randomized study.

Arm I:  Early Radiotherapy.  Involved-field irradiation using Co60 equipment, 
4-10 MeV photons, or (for small peripheral tumors) electron beams.

Arm II:  No or Late Radiotherapy.  Observation until disease progression, then 
radiotherapy as in Arm I.

van den Bent MJ, Afra D, de Witte O, et al.: Long-term efficacy of early versus delayed radiotherapy for low-grade astrocytoma and oligodendroglioma in adults: the EORTC 22845 randomised trial. Lancet 366 (9490): 985-90, 2005.[PUBMED Abstract]

van den Bent MJ, Afra D, de Witte O, et al.: Long-term results of trial EORTC 22845/MRC BR4: a randomized trial on the efficacy of radiation therapy (RT) in adult low-grade glioma. [Abstract] Neuro-Oncology 6 (4): RT-24, 364, 2004.

Karim AB, Afra D, Cornu P, et al.: Randomized trial on the efficacy of radiotherapy for cerebral low-grade glioma in the adult: European Organization for Research and Treatment of Cancer Study 22845 with the Medical Research Council study BRO4: an interim analysis. Int J Radiat Oncol Biol Phys 52 (2): 316-24, 2002.[PUBMED Abstract]

Pignatti F, van den Bent M, Curran D, et al.: Prognostic factors for survival in adult patients with cerebral low-grade glioma. J Clin Oncol 20 (8): 2076-84, 2002.[PUBMED Abstract]

Karim AB: Cure and quality of life atfer treatment for glioma. In: Karim AB, Laws ER: Principles and Practice in Neuro-Oncology. New York: Springer Verlag Berlin, 1991, pp 271-282.

Karim AB, Kralendonk JH: Pitfalls and controversies in the treatment of gliomas. In: Karim AB, Laws ER: Principles and Practice in Neuro-Oncology. New York: Springer Verlag Berlin, 1991, pp 1-16.

Shaw EG, Wisoff JH: Prospective clinical trials of intracranial low-grade glioma in adults and children. Neuro-oncol 5 (3): 153-60, 2003.[PUBMED Abstract]

Taphoorn MJ, Heimans JJ, Snoek FJ, et al.: Assessment of quality of life in patients treated for low-grade glioma: a preliminary report. J Neurol Neurosurg Psychiatry 55 (5): 372-6, 1992.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

A.B.M.F. Karim, MD, FRCR, PhD, Protocol chair(Contact information may not be current)		Ph: 31-20-444-4300

Medical Research Council Clinical Trials Unit

Norman M. Bleehen, MD, Protocol chair(Contact information may not be current)		Ph: 44-1223-245-151