Efficacy of Two Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade Glioma

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.

• Temozolomide (Drug), also known as Temodar, Temodal, Temcad, Glidar: 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).

Primary outcomes

• Overall survival [up to 1 year from start of treatment]: The time interval between the diagnosis and death.
• Progression-free survival [up to 1 year from start of treatment]: The time interval between the diagnosis and disease progression based on radiologic criteria or symptoms

Secondary outcomes

• Anemia [monthly, up to 12 months during treatment]: blood hemoglobin lower than 10 grams per deciliter
• Neutropenia [monthly, up to 12 months during treatment]: Blood almost mature neutrophils count lower than 1500/mm3
• Presence of alopecia [monthly, up to 12 months during treatment]: A condition in which hair is lost
• Presence of nausea [monthly, up to 12 months during treatment]: An unpleasant sense of unease, discomfort, and revulsion towards food
• Presence of vomiting [monthly, up to 12 months during treatment]: Eject matter from the stomach through the mouth.

Sex: All, ages: 18 Years to 70 Years

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

• Mahdi Silanian Toosi, M.D., Study director, Mashhad University of Medical Sciences
• Kazem Anvari, M.D., Study chair, Mashhad University of Medical Sciences