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

Mashhad University of Medical Sciences62 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glioblastoma Multiforme of Brain Anaplastic Astrocytoma of Brain

Interventions

TemozolomideDRUG

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (2)

Radiation ward of Emam Reza Hospital

Mashhad, Razavi Khorasan Province, Iran

RECRUITING

Omid Hospital

Mashhad, Razavi Khorasan Province, Iran

RECRUITING

Outcomes

Primary Outcomes

Overall survival

The time interval between the diagnosis and death.

Time frame: up to 1 year from start of treatment

Progression-free survival

The time interval between the diagnosis and disease progression based on radiologic criteria or symptoms

Time frame: up to 1 year from start of treatment