Hypofractionated Imrt (Vmat-Ra) For Elderly Patients With Newly Diagnosed High Grade Glioma

Phase 2CompletedNCT02099487

Istituto Clinico Humanitas20 enrolled

Overview

To assess the effect of IMRT using VMAT rapidarc approach, followed by adjuvant temozolomide on survival and quality of life in elderly, poor performance status patients with newly diagnosed HGG.

Investigators designed this study with the aim to assess the effect of IMRT using VMAT rapidarc approach, followed by adjuvant temozolomide on survival and quality of life in elderly, poor performance status patients with newly diagnosed HGG. The potential advantage of this approach is deliver a more selective irradiation to tumor's target with reducing the dose to normal brain and to allow the delivery of a higher dose, optimizing the therapeutic window.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Glioma

Interventions

RadiationRADIATION

hypofractionated IMRT

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged ≥ 70 years * Karnosky performance status (KPS) ≤60 * Histologically confirmed HGG after tumor biopsy * GBM * Anaplastic Astrocytoma * Anaplastic Oligoastrocytoma * Anaplastic Oligodendroglioma without IDH1 mutation and no codeletion 1p19q * Estimated survival ≥ 3 months. * Normal liver, Kidney and bone marrow function * Written informed consent Exclusion criteria: * Prior radiation therapy * Other primary cancer Exclusion Criteria: \-

Locations (1)

ICH Humanitas Cancer Center

Milan, Lombardy, Italy

Outcomes

Primary Outcomes

PFS

Progression free survival

Time frame: one year

Secondary Outcomes

Overall Survival

Time frame: one year

Data from ClinicalTrials.gov

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