The primary purpose of the study is to evaluate the efficacy and safety of early postsurgery temozolomide chemotherapy followed by the standard temozolomide regimen, compared to the standard regimen alone, for the treatment of patients with newly diagnosed glioblastoma multiforme.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
99
Overall Survival (OS)
OS was defined as the time from randomization to death. OS was calculated by the Kaplan-Meier method.
Time frame: Up to 2 years
Progression-Free Survival (PFS)
PFS was defined as the length of time from randomization to disease progression (the length of time during which the cancer did not get worse) or death. PFS was calculated by the Kaplan-Meier method.
Time frame: Up to 2 years
Objective Tumor Assessment After Surgery: Overall Response
Overall response was based on neuroimaging (magnetic resonance imaging \[MRI\]), clinical neurological examination, and steroid administration. It was assessed as follows: Complete Response (CR): Disappearance of all enhancing tumor (measurable or non-measurable), no corticosteroid use, and neurologically stable or improved. Partial Response (PR): ≥50% reduction in size of enhancing tumor (measurable or non-measurable) for any measurable lesions or definite improvement for any non-measurable lesions, corticosteroid dosage stable or reduced, and neurologically stable or improved. Progressive Disease (PD): ≥25% increase in contrast enhancement for any measurable lesions or definite worsening for any non-measurable lesions, or any new tumor on MRI scans, at an increased dose of corticosteroid, with or without neurologic progression. Clinical or radiological worsening resulting from other than tumor factors were excluded. Stable Disease (SD): All other situations.
Time frame: Up to 2 years
Relationship Between O6-methylguanine-DNA Methyltransferase (MGMT) Status and Therapy Response: Overall Survival for the MGMT Positive Group
MGMT was measured by immunohistochemistry (IHC). OS was defined as the length of time from the start of treatment that 1/2 of the participants were still alive. OS was calculated by the Kaplan-Meier method.
Time frame: Up to 2 years
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Relationship Between MGMT Status and Therapy Response: Overall Survival for the MGMT Negative Group
MGMT was measured by IHC. OS was defined as the length of time from the start of treatment that 1/2 of the participants were still alive. OS was calculated by the Kaplan-Meier method.
Time frame: Up to 2 years
Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Positive Group
MGMT was measured by IHC. OS rate was defined as the percentage of participants who were still alive 6, 12, \& 18 months after starting study treatment. OS was calculated by the Kaplan-Meier method.
Time frame: 6, 12, & 18 months
Relationship Between MGMT Status and Therapy Response: Overall Survival Rate for the MGMT Negative Group
MGMT was measured by IHC. OS rate was defined as the percentage of participants who were still alive 6, 12, \& 18 months after starting study treatment. OS was calculated by the Kaplan-Meier method.
Time frame: 6, 12, & 18 months
Relationship Between MGMT Status and Therapy Response: PFS for the MGMT Positive Group
MGMT was measured by IHC. PFS: The length of time during and after treatment that a participant lived with the cancer but it does not get worse. PFS was calculated by the Kaplan-Meier method.
Time frame: Up to 2 years
Relationship Between MGMT Status and Therapy Response: PFS for the MGMT Negative Group
MGMT was measured by IHC. PFS: The length of time during and after treatment that a participant lived with the cancer but it does not get worse. PFS was calculated by the Kaplan-Meier method.
Time frame: Up to 2 years