Hypofractionated IMRT With Temozolomide for HGG

N/ACompletedNCT02082119

Istituto Clinico Humanitas82 enrolled

Overview

To evaluate safety and feasibility of hypofractionated IMRT in addition to chemotherapy, concomitant and adjuvant, in patients with newly diagnosed HGGs after surgery. Primary endpoint: progression free survival (PFS), Overall Survival (OS) and Toxicity. Secondary endpoint: to evaluate Quality of life (QoL) of patients after surgery, concomitant chemoradiotherapy and adjuvant chemotherapy through neuropsychological examination.

We designed a study of a hypofractionated intensity modulated radiation therapy (IMRT), using VMAT RapidArc approach. The potential advantage of this approach is to deliver a more selective irradiation to tumor's target with reducing dose to normal brain and to allow to deliver a higher dose, optimizing the therapeutic window

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glioma

Interventions

Hypofractionated IMRTRADIATION

Hypofractionated IMRT

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 to 70 years * Karnosky performance status (KPS) ≥60 * Patients aged \>70 years with KPS ≥80 * Histopathologically confirmed of HGG * Estimated survival ≥ 3 months. * Multifocal tumor * Normal liver, Kidney and bone marrow function * Written informed consent Exclusion Criteria: * Prior radiation therapy * KPS ≤ 60 * Age \> 70 years and KPS \< 70 * Other primary cancer * Pregnant women

Locations (1)

Istituto Clinico Humanitas

Milan, Italy

Outcomes

Primary Outcomes

Progression Free Survival (PFS)

Progression free survival is defined by any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids; a significant increase in T2/FLAIR non-enhancing lesions on stable or increasing dose of corticosteroids compared with baseline scan or best response after initial of therapy, not due to comorbid events; the appearance of any new lesions; clear progression of non-measurable lesions; or definite clinical deterioration not attributable to another causes apart from the tumor, or to decrease in corticosteroid dose.

Time frame: 1 year

Secondary Outcomes

Quality of Life (QoL) of Patients After Surgery, Concomitant Chemo-radiotherapy and Adjuvant Chemotherapy

Quality of life (QoL) of patients after surgery, concomitant chemoradiotherapy and adjuvant chemotherapy is evaluated through neuropsychological examination using the Milano-Bicocca Battery (MIBIB). This battery investigated language, memory, apraxia, including visuo-constructional abilities, executive functions and spatial cognition.

Time frame: 1 year

Data from ClinicalTrials.gov

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