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

Sponsor

Istituto Clinico Humanitas (Other)

Overall Status

Completed

CT.gov ID

NCT02099487

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Glioma	Radiation: Radiation	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Radiation To evaluate safety and feasibility of hypofractionated Intensity Modulated Radiotherapy	Radiation: Radiation hypofractionated IMRT

Arm

Intervention/Treatment

Experimental: Radiation

To evaluate safety and feasibility of hypofractionated Intensity Modulated Radiotherapy

Radiation: Radiation

hypofractionated IMRT

Outcome Measures

Primary Outcome Measures

PFS [one year]
Progression free survival

Secondary Outcome Measures

OS [one year]
Overall Survival

Other Outcome Measures

Toxicity [one year]
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
QoL [one year]
Quality of Life

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ICH Humanitas Cancer Center	Milan	Lombardia	Italy	20090

Sponsors and Collaborators

Istituto Clinico Humanitas

Investigators

Study Director: Piera Navarria, MD, Humanitas Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michele Tedeschi, M.D., Istituto Clinico Humanitas

ClinicalTrials.gov Identifier:

NCT02099487

Other Study ID Numbers:

1139

First Posted:

Mar 31, 2014

Last Update Posted:

May 20, 2016

Last Verified:

Jan 1, 2014

Keywords provided by Michele Tedeschi, M.D., Istituto Clinico Humanitas

HGG

Additional relevant MeSH terms:

Glioma

Study Results

No Results Posted as of May 20, 2016