Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma

Not Applicable

Completed

• Conditions: Recurrent High Grade Glioma
• Interventions: Radiation: IMRT with or without radiosensitive therapy; Drug: Radiosensitive therapy

• Registration Number: NCT02567539
• Lead Sponsor: Istituto Clinico Humanitas

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.

Study Timeline

• Study Start: 2015-05-27
• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-10-02
• Study First Posted: 2015-10-05
• Primary Completion: 2022-06
• Study Completion: 2022-06
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-14
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Recurrent high grade glioma	IMRT with or without radiosensitive therapy	IMRT with or without radiosensitive therapy
Recurrent high grade glioma	Radiosensitive therapy	IMRT with or without radiosensitive therapy

Primary Outcome Measures

Name	Time	Method
Progression free of participants	4 years
Overall survival of participants	4 years

Secondary Outcome Measures

Name	Time	Method
Incidence of radionecrosis	3 months
Questionnaire assessment of neurocognitive function	6 months

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milan, Italy