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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 September 2022 |
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Main ID: |
NCT02567539 |
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Date of registration:
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28/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma
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Scientific title:
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Phase II Study of Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma |
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Date of first enrolment:
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May 27, 2015 |
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Target sample size:
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88 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02567539 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Italy
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Contacts
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Name:
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Piera Navarria, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Istituto Clinico Humanitas |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age > 18 years
- Karnosky performance status (KPS) =70
- Patients aged >70 years with KPS =80
- Histopathologically confirmed grade III-IV glioma
- Estimated survival = 3 months
- Any Tumor volume
- Unifocal tumor
- Interval time from previous radiotherapy = 6mesi
- Normal liver, Kidney and bone marrow function
- Written informed consent
Exclusion Criteria:
- KPS < 70
- Multifocal tumor
- Other primary cancer
- Pregnant women
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Recurrent High Grade Glioma
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Intervention(s)
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Radiation: IMRT with or without radiosensitive therapy
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Drug: Radiosensitive therapy
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Primary Outcome(s)
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Progression free of participants
[Time Frame: 4 years]
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Overall survival of participants
[Time Frame: 4 years]
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Secondary Outcome(s)
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Questionnaire assessment of neurocognitive function
[Time Frame: 6 months]
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Incidence of radionecrosis
[Time Frame: 3 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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