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Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma

Primary Purpose

Recurrent High Grade Glioma

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
IMRT with or without radiosensitive therapy
Radiosensitive therapy
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent High Grade Glioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istituto Clinico Humanitas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Recurrent high grade glioma

Arm Description

IMRT with or without radiosensitive therapy

Outcomes

Primary Outcome Measures

Progression free of participants
Overall survival of participants

Secondary Outcome Measures

Incidence of radionecrosis
Questionnaire assessment of neurocognitive function

Full Information

First Posted
September 28, 2015
Last Updated
September 14, 2022
Sponsor
Istituto Clinico Humanitas
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1. Study Identification

Unique Protocol Identification Number
NCT02567539
Brief Title
Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma
Official Title
Phase II Study of Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 27, 2015 (Actual)
Primary Completion Date
June 2022 (Actual)
Study Completion Date
June 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Clinico Humanitas

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent High Grade Glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recurrent high grade glioma
Arm Type
Experimental
Arm Description
IMRT with or without radiosensitive therapy
Intervention Type
Radiation
Intervention Name(s)
IMRT with or without radiosensitive therapy
Other Intervention Name(s)
Hypofractionated Stereotactic Radiation
Intervention Description
Re-irradiation with hypofractionated intensity modulated radiation therapy (IMRT), using VMAT RapidArc
Intervention Type
Drug
Intervention Name(s)
Radiosensitive therapy
Other Intervention Name(s)
Chemotherapy
Intervention Description
Radiosensitive therapy with Temozolomide
Primary Outcome Measure Information:
Title
Progression free of participants
Time Frame
4 years
Title
Overall survival of participants
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Incidence of radionecrosis
Time Frame
3 months
Title
Questionnaire assessment of neurocognitive function
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piera Navarria, MD
Organizational Affiliation
Istituto Clinico Humanitas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milan
ZIP/Postal Code
20089
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
25761491
Citation
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.
Results Reference
result
PubMed Identifier
26118437
Citation
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.
Results Reference
result
PubMed Identifier
34952000
Citation
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.
Results Reference
derived

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Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma

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