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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Single-blind, Randomized, Clinical Trial Comparing the Efficacy of 6 Cycles Versus 12 Cycles Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade Glioma

Conditions
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Glioblastoma Multiforme of Brain, Anaplastic Astrocytoma of Brain

Intervention / Treatment
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* Drug: Temozolomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients will be randomized to 6-cycle and 12-cycle adjuvant Temozolomide groups using block randomization method (1:1).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12-cycle arm<br>After completion of chemoradiation, the cases will receive 12 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meters body surface per day for the first 5 days of every 28 days). | Drug: Temozolomide<br>* 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).<br>* Other names: Temodar, Temodal, Temcad, Glidar;|
| Active Comparator: 6-cycle arm<br>After completion of chemoradiation, the participants will receive 6 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meters body surface per day for the first 5 days of every 28 days). | Drug: Temozolomide<br>* 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).<br>* Other names: Temodar, Temodal, Temcad, Glidar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | The time interval between the diagnosis and death. | 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 | up to 1 year from start of treatment | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glioblastoma Multiforme, Anaplastic Astrocytoma, Adjuvant treatment, Extended chemotherapy