Clinical trial NCT03633552: Efficacy of Two Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade Glioma
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Glioblastoma Multiforme of Brain
Anaplastic Astrocytoma of Brain
Keywords: Glioblastoma Multiforme
Anaplastic Astrocytoma
Adjuvant treatment
Extended chemotherapy
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be randomized to 6-cycle and 12-cycle adjuvant Temozolomide groups using block randomization method (1:1).
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: up to 1 year from start of treatment
measure: Progression-free survival
timeFrame: up to 1 year from start of treatment
Secondary outcomes:
measure: Anemia
timeFrame: monthly, up to 12 months during treatment
measure: Neutropenia
timeFrame: monthly, up to 12 months during treatment
measure: Presence of alopecia
timeFrame: monthly, up to 12 months during treatment
measure: Presence of nausea
timeFrame: monthly, up to 12 months during treatment
measure: Presence of vomiting
timeFrame: monthly, up to 12 months during treatment
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Radiation ward of Emam Reza Hospital
state: Razavi Khorasan
city: Mashhad
country: Iran, Islamic Republic of
facility: Omid Hospital
state: Razavi Khorasan
Study officials:
affiliation: Mashhad University of Medical Sciences
name: Mahdi Silanian Toosi, M.D.
role: STUDY_DIRECTOR
affiliation: Mashhad University of Medical Sciences
name: Kazem Anvari, M.D.
role: STUDY_CHAIR
References: