Protocol summary
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Study aim
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Evaluation of the efficacy and side effects of cyclosporine in the treatment of patients with glioblastoma multiforme
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Design
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Two arm parallel groups, randomised trial with blinded postoperative care and outcome assessment, phase 2-3 on 99 patients. Computer sequencing was used for randomization.
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Settings and conduct
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Patients referred to Shariati Hospital in Tehran, who were definitively diagnosed with glioblastoma based on frozen section surgery, were randomly alocated to the study. Patients then received envelopes labeled A and B containing the cyclosporine or placebo. In this study, patients, researchers and analyzers were not aware of the individuals assigned to the study groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1. Age over 18 years
2. Definitive diagnosis of glioblastoma tumor
Exclusion criteria:
1. History of previous brain tumor surgery
2. Receive previous chemotherapy
3. Pregnancy
4. Breastfeeding
5. Immune defect
6. Active infection
7. Hepatitis
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Intervention groups
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Intervention group: Injectable cyclosporine (2.5 mg / kg for 2 hours for the patient and then infused at a dose of 5 mg / kg per day for 72 hours)
Control group: receiving placebo
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Main outcome variables
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Overall survival
Progression-free survival
One year survival
Performanc status (Karnovsky score)
General information
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Reason for update
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Regarding the completion of the study, some conditions related to the design of the study were updated.
1. The study was conducted as triple blind.
2. In addition to standard treatment, the control group also received a placebo.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201512028612N3
Registration date:
2016-01-22, 1394/11/02
Registration timing:
registered_while_recruiting
Last update:
2022-01-18, 1400/10/28
Update count:
1
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Registration date
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2016-01-22, 1394/11/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Tehran University of Medical Science, Shariati Hospital
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Expected recruitment start date
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2014-07-23, 1393/05/01
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Expected recruitment end date
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2016-04-20, 1395/02/01
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Actual recruitment start date
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2014-07-23, 1393/05/01
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Actual recruitment end date
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2017-04-21, 1396/02/01
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Trial completion date
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2020-03-20, 1399/01/01
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Scientific title
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A Clinical trial to assess the effects of short-term administration of cyclosporine on survival of patients with glioblastoma multiforme tumor surgery
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Public title
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Effect of an immuno-suppresive medication (cyclosporine) on brain tumor patients survival
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age over 18 years
No history of surgery and/or previous chemoteraphy
Confirmed diagnosis of gliobalstoma
Exclusion criteria:
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Age
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From 18 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
40
Actual sample size reached:
99
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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A computer-generated sequence with a block size of 4 patients was used for randomization. The patients were assigned consecutive numbers based on their order of enrolment in the study. Thus, unblinded pharmacists who were otherwise uninvolved in study conduct obtained randomized treatment assignments and managed study treatment
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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Patients were allocated to group A and B and received envelopes labeled A and B that contained Cyclosporine or placebo after surgery. Hence, neither the patients nor all investigators were aware of the drug contents and group allocation.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2015-06-17, 1394/03/27
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Ethics committee reference number
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IR.TUMS.REC.1394.76
Health conditions studied
1
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Description of health condition studied
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glioblastoma multiform
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ICD-10 code
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C71.9
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ICD-10 code description
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Malignant neoplasm of brain/unspecified
Primary outcomes
1
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Description
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Performance Status (Survival)
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Timepoint
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measured every 2 months after recruitment up to one year
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Method of measurement
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Karnofsky Performance Status Scale
Intervention groups
1
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Description
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Infusion of 2.5 mg/kg cyclosporine over first 2 hours post operation and will be continued with the dose of 5mg/kg /day for 72 hours
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Category
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Treatment - Drugs
2
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Description
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control group:
routine care of post op GBM patients
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Publish as scintifice article
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When the data will become available and for how long
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from 2021
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To whom data/document is available
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Researchers
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Under which criteria data/document could be used
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To design future studies
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From where data/document is obtainable
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Dr. Alireza Khoshnevisan
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What processes are involved for a request to access data/document
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Formal request to principal researcher of study
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Comments
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