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CE6 Details
Status: Closed 
Activation Date: 2007MAY01
Closing Date: 2013OCT01
Phase: III 

Description: A Randomized Phase III Study of Temozolomide and Short-Course Radiation vs. Short-Course Radiation Alone in the Treatment of Newly Diagnosed Glioblastoma Multiforme in Elderly Patients. 

Eligibility: Patients 65 years of age or older, with newly diagnosed, histopathologically confirmed, glioblastoma multiforme (GBM, WHO grade IV), who have had prior surgery/biopsy at diagnosis and who are not deemed suitable by their treating physician to receive the standard radiotherapy regimen (60Gy/30 fractions over 6 weeks) in combination with temozolomide. 

Objective: PRIMARY: To compare the overall survival (OS) rates between short-course radiation therapy alone and short-course radiation therapy given together with concurrent and adjuvant temozolomide, in elderly (65 years of age or older) patients with newly diagnosed glioblastoma multiforme (GBM, WHO grade IV), who have had prior surgery/biopsy at diagnosis and who are not deemed suitable by their treating physician to receive the standard radiotherapy regimen (60Gy/30 fractions over 6 weeks) in combination with temozolomide. SECONDARY: To compare progression-free survival (PFS) between the two arms; To compare the nature, severity, and frequency of adverse events between the two arms; To compare the quality of life between the two arms using the EORTC QLQ-C30 and the EORTC Brain Cancer Module (QLQ-BN20); To conduct molecular correlative studies (mandatory: MGMT promoter status; optional: tissue banking). 

Participation: Open to member centres 

Lay Description: Glioblastoma Multiforme (GBM) is a type of brain cancer treated with surgery and radiation therapy (RT). Temozolomide (TMZ) is a new drug. A previous clinical study in GBM patients up to 71 years of age showed that when TMZ is added to the usual (i.e. "long") course of RT it slows the growth of GBM and prolongs life compared to treatment with the long course of RT alone. However, the results of this trial suggested that the benefit from TMZ decreases with increasing age. Also, elderly patients are not usually able to tolerate the long RT course and are instead perscribed a shorter one. Thus, researchers do not know if TMZ is of benefit to elderly patients, neither do they know if its combination with the short course of RT will be as effective as with the long course of RT. CE.6 will attempt to answer these questions by enrolling GBM patients 65 yers or older who are not considered suitable for the long course RT. Patients will be randomized to short RT alone or to short RT plus TMZ. 

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