Hypofractionated IMRT With Temozolomide for HGG

Not Applicable

Completed

• Conditions: Glioma
• Interventions: Radiation: Hypofractionated IMRT

• Registration Number: NCT02082119
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-12-13
• Study First Submitted QC: 2014-03-05
• Study First Posted: 2014-03-10
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Results First Submitted: 2016-12-13
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-17
• Last Update Submitted: 2020-09-17
• Results First Posted: 2020-10-12
• Last Update Posted: 2020-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High Grade Glioma	Hypofractionated IMRT	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.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Life (QoL) of Patients After Surgery, Concomitant Chemo-radiotherapy and Adjuvant Chemotherapy	1 year	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.

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Milan, Italy