Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma
NCT ID: NCT02567539
Last Updated: 2022-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
88 participants
INTERVENTIONAL
2015-05-27
2022-06-30
Brief Summary
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Detailed Description
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Objective of the study is evaluating efficacy and safety of re-irradiation for patients with recurrent high grade gliomas after other treatment.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Recurrent high grade glioma
IMRT with or without radiosensitive therapy
IMRT with or without radiosensitive therapy
Re-irradiation with hypofractionated intensity modulated radiation therapy (IMRT), using VMAT RapidArc
Radiosensitive therapy
Radiosensitive therapy with Temozolomide
Interventions
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IMRT with or without radiosensitive therapy
Re-irradiation with hypofractionated intensity modulated radiation therapy (IMRT), using VMAT RapidArc
Radiosensitive therapy
Radiosensitive therapy with Temozolomide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Multifocal tumor
* Other primary cancer
* Pregnant women
18 Years
ALL
No
Sponsors
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Istituto Clinico Humanitas
OTHER
Responsible Party
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Michele Tedeschi
MD
Principal Investigators
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Piera Navarria, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Clinico Humanitas
Locations
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Istituto Clinico Humanitas
Rozzano, Milan, Italy
Countries
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References
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Navarria P, Ascolese AM, Tomatis S, Reggiori G, Clerici E, Villa E, Maggi G, Bello L, Pessina F, Cozzi L, Scorsetti M. Hypofractionated Stereotactic Radiation Therapy in Recurrent High-Grade Glioma: A New Challenge. Cancer Res Treat. 2016 Jan;48(1):37-44. doi: 10.4143/crt.2014.259. Epub 2015 Feb 23.
Scorsetti M, Navarria P, Pessina F, Ascolese AM, D'Agostino G, Tomatis S, De Rose F, Villa E, Maggi G, Simonelli M, Clerici E, Soffietti R, Santoro A, Cozzi L, Bello L. Multimodality therapy approaches, local and systemic treatment, compared with chemotherapy alone in recurrent glioblastoma. BMC Cancer. 2015 Jun 30;15:486. doi: 10.1186/s12885-015-1488-2.
Navarria P, Pessina F, Clerici E, Bellu L, Franzese C, Franzini A, Simonelli M, Bello L, Santoro A, Politi LS, D'agostino GR, Casarotti A, Fernandes B, Torri V, Scorsetti M. Re-irradiation for recurrent high grade glioma (HGG) patients: Results of a single arm prospective phase 2 study. Radiother Oncol. 2022 Feb;167:89-96. doi: 10.1016/j.radonc.2021.12.019. Epub 2021 Dec 22.
Other Identifiers
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1394
Identifier Type: -
Identifier Source: org_study_id
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