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

NCT ID: NCT03633552

Last Updated: 2018-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-03
• Study Completion Date: 2021-04-03

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.

Conditions

Glioblastoma Multiforme of Brain; Anaplastic Astrocytoma of Brain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

12-cycle arm

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).

Group Type: EXPERIMENTAL

Temozolomide

Intervention Type: DRUG

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).

6-cycle arm

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).

Group Type: ACTIVE_COMPARATOR

Temozolomide

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Temodar, Temodal, Temcad, Glidar

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mashhad University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Seyed Alireza Javadinia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mahdi Silanian Toosi, M.D.

Role: STUDY_DIRECTOR

Mashhad University of Medical Sciences

Kazem Anvari, M.D.

Role: STUDY_CHAIR

Mashhad University of Medical Sciences

Locations

Radiation ward of Emam Reza Hospital

Mashhad, Razavi Khorasan Province, Iran

Site Status: RECRUITING

Omid Hospital

Mashhad, Razavi Khorasan Province, Iran

Site Status: RECRUITING

Countries

Iran

Central Contacts

Seyed Alireza Javadinia, M.D.

Role: CONTACT

Javadiniaa941@mums.ac.ir

00989155728157

Mohammadreza Saghafi, M.D.

Role: CONTACT

SaghafiMR951@mums.ac.ir

00989127898938

Facility Contacts

Roham Salek, M.D.

Role: primary

SalekR@mums.ac.ir

+985138426936

Seyed Amir Aledavood, M.D.

Role: primary

AledavoodA@mums.ac.ir

+985138426936

Other Identifiers

IRCT20160706028815N3

Identifier Type: REGISTRY

Identifier Source: secondary_id

960021

Identifier Type: -

Identifier Source: org_study_id