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

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ClinicalTrials.gov Identifier: NCT03633552
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Seyed Alireza Javadinia, Mashhad University of Medical Sciences

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).

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme of Brain Anaplastic Astrocytoma of Brain Drug: Temozolomide Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : March 3, 2018
Estimated Primary Completion Date : March 3, 2021
Estimated Study Completion Date : April 3, 2021


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 Name: 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 Name: Temodar, Temodal, Temcad, Glidar




Primary Outcome Measures :
  1. Overall survival [ Time Frame: up to 1 year from start of treatment ]
    The time interval between the diagnosis and death.

  2. Progression-free survival [ Time Frame: up to 1 year from start of treatment ]
    The time interval between the diagnosis and disease progression based on radiologic criteria or symptoms


Secondary Outcome Measures :
  1. Anemia [ Time Frame: monthly, up to 12 months during treatment ]
    blood hemoglobin lower than 10 grams per deciliter

  2. Neutropenia [ Time Frame: monthly, up to 12 months during treatment ]
    Blood almost mature neutrophils count lower than 1500/mm3

  3. Presence of alopecia [ Time Frame: monthly, up to 12 months during treatment ]
    A condition in which hair is lost

  4. Presence of nausea [ Time Frame: monthly, up to 12 months during treatment ]
    An unpleasant sense of unease, discomfort, and revulsion towards food

  5. Presence of vomiting [ Time Frame: monthly, up to 12 months during treatment ]
    Eject matter from the stomach through the mouth.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633552


Contacts
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Contact: Seyed Alireza Javadinia, M.D. 00989155728157 Javadiniaa941@mums.ac.ir
Contact: Mohammadreza Saghafi, M.D. 00989127898938 SaghafiMR951@mums.ac.ir

Locations
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Iran, Islamic Republic of
Radiation ward of Emam Reza Hospital Recruiting
Mashhad, Razavi Khorasan, Iran, Islamic Republic of, 9137913316
Contact: Roham Salek, M.D.    +985138426936    SalekR@mums.ac.ir   
Principal Investigator: Kazem Anvari, M.D.         
Omid Hospital Recruiting
Mashhad, Razavi Khorasan, Iran, Islamic Republic of, 917661377
Contact: Seyed Amir Aledavood, M.D.    +985138426936    AledavoodA@mums.ac.ir   
Principal Investigator: Kazem Anvari, M.D.         
Principal Investigator: Mahdi Silanian Toosi, M.D.         
Sponsors and Collaborators
Mashhad University of Medical Sciences
Investigators
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Study Director: Mahdi Silanian Toosi, M.D. Mashhad University of Medical Sciences
Study Chair: Kazem Anvari, M.D. Mashhad University of Medical Sciences

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Responsible Party: Seyed Alireza Javadinia, Principal Investigator, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03633552     History of Changes
Other Study ID Numbers: 960021
IRCT20160706028815N3 ( Registry Identifier: Iranian Registry of Clinical Trials )
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make this available.

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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

Keywords provided by Seyed Alireza Javadinia, Mashhad University of Medical Sciences:
Glioblastoma Multiforme
Anaplastic Astrocytoma
Adjuvant treatment
Extended chemotherapy

Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents