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

Primary Purpose

Glioma

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Radiation
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioma focused on measuring HGG

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept 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:

-

Sites / Locations

  • ICH Humanitas Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation

Arm Description

To evaluate safety and feasibility of hypofractionated Intensity Modulated Radiotherapy

Outcomes

Primary Outcome Measures

PFS
Progression free survival

Secondary Outcome Measures

OS
Overall Survival

Full Information

First Posted
January 24, 2014
Last Updated
May 19, 2016
Sponsor
Istituto Clinico Humanitas
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1. Study Identification

Unique Protocol Identification Number
NCT02099487
Brief Title
Hypofractionated Imrt (Vmat-Ra) For Elderly Patients With Newly Diagnosed High Grade Glioma
Official Title
Hypofractionated Imrt (Vmat-Ra) With Temozolomide For Elderly Patients, Unsuitable For Surgery With Newly Diagnosed High Grade Glioma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Clinico Humanitas

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
Keywords
HGG

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiation
Arm Type
Experimental
Arm Description
To evaluate safety and feasibility of hypofractionated Intensity Modulated Radiotherapy
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Description
hypofractionated IMRT
Primary Outcome Measure Information:
Title
PFS
Description
Progression free survival
Time Frame
one year
Secondary Outcome Measure Information:
Title
OS
Description
Overall Survival
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
Toxicity
Description
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
Time Frame
one year
Title
QoL
Description
Quality of Life
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piera Navarria, MD
Organizational Affiliation
Humanitas Cancer Center
Official's Role
Study Director
Facility Information:
Facility Name
ICH Humanitas Cancer Center
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20090
Country
Italy

12. IPD Sharing Statement

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

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