Hypofractionated IMRT With Temozolomide for HGG

Istituto Clinico Humanitas

Status: Completed

Conditions: Glioma

Treatments: Radiation: Hypofractionated IMRT

Study type: Interventional

Funder types: Other

Identifiers

NCT02082119

1138

Details and patient eligibility

About

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.

Full description

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

Enrollment: 82 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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82 participants in 1 patient group

High Grade Glioma

Experimental group

Description:

To evaluate safety and feasibility of hypofractionated IMRT in addition to chemotherapy, concomitant and adjuvant, in patients with newly diagnosed High Grade Glioma after biopsy.total dose of 60 Gy/ 4 Gy fraction/15 fractions (BED10 84 Gy) will prescribed to the PTV1; a total dose of 42 Gy/2.8 Gy fraction/15 fractions (BED10 53.76 Gy) will prescribed to PTV2 with SIB.

Treatment:

Radiation: Hypofractionated IMRT