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

Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02099487
• Other study ID #: 1139
• Status: Completed
• Phase: Phase 2
• First received: January 24, 2014
• Last updated: May 19, 2016
• Start date: July 2013
• Est. completion date: May 2016

Study information

• Verified date: January 2014
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioma

Intervention

Radiation:
• Radiation
hypofractionated IMRT

Locations

Country	Name	City	State
Italy	ICH Humanitas Cancer Center	Milan	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Toxicity	Incidence of hematologic and non hematologic severe toxicities (grade III/ IV) will evaluate using NCI-CTCA scale. Late toxicity will evaluate using CTCA 4.2	one year	Yes
Other	QoL	Quality of Life	one year	Yes
Primary	PFS	Progression free survival	one year	Yes
Secondary	OS	Overall Survival	one year	Yes