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

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

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).

Study Overview

• Status: Unknown
• Conditions: Glioblastoma Multiforme of Brain; Anaplastic Astrocytoma of Brain
• Intervention / Treatment: Drug: Temozolomide

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.

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Seyed Alireza Javadinia, M.D.; Phone Number: 00989155728157; Email: Javadiniaa941@mums.ac.ir
• Study Contact Backup: Name: Mohammadreza Saghafi, M.D.; Phone Number: 00989127898938; Email: SaghafiMR951@mums.ac.ir

Study Locations

• Iran, Islamic Republic of
  • Razavi Khorasan
    • Mashhad, Razavi Khorasan, Iran, Islamic Republic of, 9137913316
      • Recruiting
      • Radiation ward of Emam Reza Hospital
      • Contact: Roham Salek, M.D.; Phone Number: +985138426936; Email: SalekR@mums.ac.ir
      • Principal Investigator: Kazem Anvari, M.D.
    • Mashhad, Razavi Khorasan, Iran, Islamic Republic of, 917661377
      • Recruiting
      • Omid Hospital
      • Principal Investigator: Kazem Anvari, M.D.
      • Contact: Seyed Amir Aledavood, M.D.; Phone Number: +985138426936; Email: AledavoodA@mums.ac.ir
      • Principal Investigator: Mahdi Silanian Toosi, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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).; Other Names: Temodar, Temodal, Temcad, Glidar
Active Comparator: 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).	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).; Other Names: Temodar, Temodal, Temcad, Glidar

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mashhad University of Medical Sciences
• Investigators: Study Director: Mahdi Silanian Toosi, M.D., Mashhad University Of Medical Sciences; Study Chair: Kazem Anvari, M.D., Mashhad University Of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2018
• Primary Completion (Anticipated): March 3, 2021
• Study Completion (Anticipated): April 3, 2021

Study Registration Dates

• First Submitted: July 20, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): August 16, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Glioblastoma Multiforme; Adjuvant treatment; Anaplastic Astrocytoma; Extended chemotherapy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Astrocytoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Temozolomide
• Other Study ID Numbers: 960021; IRCT20160706028815N3 (Registry Identifier: Iranian Registry of Clinical Trials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: It is not yet known if there will be a plan to make this available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes