Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma

NCT ID: NCT02567539

Last Updated: 2022-09-15

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-27

Study Completion Date

2022-06-30

Brief Summary

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The study is aimed to evaluate efficacy and safety of re-irradiation for patients with recurrent high grade gliomas after other treatment.

Detailed Description

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Investigators designed this study of a re-irradiation with single radiosurgery or hypofractionated intensity modulated radiation therapy (IMRT) with or without temozolomide.

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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Recurrent High Grade Glioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Recurrent high grade glioma

IMRT with or without radiosensitive therapy

Group Type EXPERIMENTAL

IMRT with or without radiosensitive therapy

Intervention Type RADIATION

Re-irradiation with hypofractionated intensity modulated radiation therapy (IMRT), using VMAT RapidArc

Radiosensitive therapy

Intervention Type DRUG

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

Intervention Type RADIATION

Radiosensitive therapy

Radiosensitive therapy with Temozolomide

Intervention Type DRUG

Other Intervention Names

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Hypofractionated Stereotactic Radiation Chemotherapy

Eligibility 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Michele Tedeschi

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Italy

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.

Reference Type RESULT
PMID: 25761491 (View on PubMed)

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.

Reference Type RESULT
PMID: 26118437 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34952000 (View on PubMed)

Other Identifiers

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1394

Identifier Type: -

Identifier Source: org_study_id

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