Phase III Randomized Comparison of Early vs No or Late Radiotherapy in Adult Patients with Grade I/II Supratentorial Astrocytomas and Oligodendrogliomas
Radiation Therapy in Treating Adult Patients With Brain Cancer
Basic Trial Information
|Phase III||Treatment||Closed||16 to 65||EORTC-22845|
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.
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
No prior therapy other than surgery, corticosteroids, anticonvulsants, and diuretics
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
About 5 years will be necessary to accrue the required 100 patients per arm.
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]
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
Medical Research Council Clinical Trials Unit
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.