Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma

Recurrent High Grade Glioma Clinical Trial

Official title:

Phase II Study of Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02567539
• Other study ID #: 1394
• Status: Completed
• Phase: N/A
• Start date: May 27, 2015
• Est. completion date: June 2022

Study information

• Verified date: September 2022
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Recurrence
• Recurrent High Grade Glioma

Intervention

Radiation:
• IMRT with or without radiosensitive therapy
Re-irradiation with hypofractionated intensity modulated radiation therapy (IMRT), using VMAT RapidArc

Drug:
• Radiosensitive therapy
Radiosensitive therapy with Temozolomide

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View 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 chemothe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free of participants		4 years
Primary	Overall survival of participants		4 years
Secondary	Incidence of radionecrosis		3 months
Secondary	Questionnaire assessment of neurocognitive function		6 months