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

Glioblastoma Multiforme of Brain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03633552
• Other study ID #: 960021
• Secondary ID: IRCT201607060288
• Status: Recruiting
• Phase: Phase 3
• Start date: March 3, 2018
• Est. completion date: April 3, 2021

Study information

• Verified date: August 2018
• Source: Mashhad University of Medical Sciences
• Contact: Seyed Alireza Javadinia, M.D.
• Phone: 00989155728157
• Email: Javadiniaa941[@]mums.ac.ir
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: April 3, 2021
• Est. primary completion date: March 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anaplastic Astrocytoma of Brain
• Astrocytoma
• Glioblastoma
• Glioblastoma Multiforme of Brain

Intervention

Drug:
• Temozolomide
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).

Locations

Country	Name	City	State
Iran, Islamic Republic of	Omid Hospital	Mashhad	Razavi Khorasan
Iran, Islamic Republic of	Radiation ward of Emam Reza Hospital	Mashhad	Razavi Khorasan

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	The time interval between the diagnosis and death.	up to 1 year from start of treatment
Primary	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	Anemia	blood hemoglobin lower than 10 grams per deciliter	monthly, up to 12 months during treatment
Secondary	Neutropenia	Blood almost mature neutrophils count lower than 1500/mm3	monthly, up to 12 months during treatment
Secondary	Presence of alopecia	A condition in which hair is lost	monthly, up to 12 months during treatment
Secondary	Presence of nausea	An unpleasant sense of unease, discomfort, and revulsion towards food	monthly, up to 12 months during treatment
Secondary	Presence of vomiting	Eject matter from the stomach through the mouth.	monthly, up to 12 months during treatment