Efficacy of Two Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade Glioma
Efficacy of Two Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade Glioma
This is a phase III, non-blinded, blocked randomized clinical trial. The study is conducted
 on 62 newly diagnosed patients with brain glioblastoma multiforme and anaplastic astrocytoma
 referring to the oncology clinics during March 2018 and March 2019. The patients will be
 randomized to 6-cycle and 12-cycle adjuvant Temozolomide groups using block randomization
 method (1:1).
This study aimed to compare the overall survival and progression free survival between 6
 cycles and 12 cycles adjuvant Temozolomide regimens in patients with brain glioblastoma and
 anaplastic astrocytoma. The main inclusion criterion includes patients newly diagnosed with
 glioblastoma and anaplastic astrocytoma whose diagnosis is confirmed by histologic
 evaluation. The main exclusion criteria involve chronic renal, hepatic or cardiac failure.
 The patients will initially undergo surgery. Within 4 to 6 weeks after surgery, all patients
 will receive chemoradiation. After completion of chemoradiation, the cases will receive 12
 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meter body
 surface per day for the first 5 days of every 28 days). In the control group, the patients
 will receive 6 cycles of adjuvant Temozolomide (in the same dosage). This is a phase III,
 non-blinded, blocked randomized clinical trial. The study is conducted on 62 newly diagnosed
 patients with brain glioblastoma multiforme and anaplastic astrocytoma referring to the
 oncology clinics during March 2018 and March 2019. The patients will be randomized to 6-cycle
 and 12-cycle adjuvant Temozolomide groups using block randomization method (1:1). This study
 will be conducted in the oncology clinic of Omid Hospital and Imam Reza Hospital, Mashhad.
 Blinding is not observed in this study. The primary endpoints of study are overall survival
 and progression free survival.
Inclusion Criteria:

 -  Newly diagnosed glioblastoma and anaplastic astrocytoma

 -  age between 18 and 70 years

 -  Karnofsky Performance Scale Index equal or more than 60 percent

 -  signed informed consent

 Exclusion Criteria:

 -  chronic hepatic

 -  renal failure

 -  cardiac failure

 -  history of hematologic malignancies