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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

Tracking Information
First Submitted Date  ICMJE July 20, 2018
First Posted Date  ICMJE August 16, 2018
Last Update Posted Date August 16, 2018
Actual Study Start Date  ICMJE March 3, 2018
Estimated Primary Completion Date March 3, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
  • Overall survival [ Time Frame: up to 1 year from start of treatment ]
    The time interval between the diagnosis and death.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
  • Anemia [ Time Frame: monthly, up to 12 months during treatment ]
    blood hemoglobin lower than 10 grams per deciliter
  • Neutropenia [ Time Frame: monthly, up to 12 months during treatment ]
    Blood almost mature neutrophils count lower than 1500/mm3
  • Presence of alopecia [ Time Frame: monthly, up to 12 months during treatment ]
    A condition in which hair is lost
  • Presence of nausea [ Time Frame: monthly, up to 12 months during treatment ]
    An unpleasant sense of unease, discomfort, and revulsion towards food
  • Presence of vomiting [ Time Frame: monthly, up to 12 months during treatment ]
    Eject matter from the stomach through the mouth.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Two Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade Glioma
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Glioblastoma Multiforme of Brain
  • Anaplastic Astrocytoma of Brain
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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).
    Intervention: Drug: Temozolomide
  • 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).
    Intervention: Drug: Temozolomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 13, 2018)
62
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 3, 2021
Estimated Primary Completion Date March 3, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Seyed Alireza Javadinia, M.D. 00989155728157 Javadiniaa941@mums.ac.ir
Contact: Mohammadreza Saghafi, M.D. 00989127898938 SaghafiMR951@mums.ac.ir
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03633552
Other Study ID Numbers  ICMJE 960021
IRCT20160706028815N3 ( Registry Identifier: Iranian Registry of Clinical Trials )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make this available.
Responsible Party Seyed Alireza Javadinia, Mashhad University of Medical Sciences
Study Sponsor  ICMJE Mashhad University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mahdi Silanian Toosi, M.D. Mashhad University of Medical Sciences
Study Chair: Kazem Anvari, M.D. Mashhad University of Medical Sciences
PRS Account Mashhad University of Medical Sciences
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP