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CompletedNCT02099487Updated May 20, 2016

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

A Phase 2 interventional study of Radiation in Glioma, sponsored by Istituto Clinico Humanitas. Completed at 1 site in Italy. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2016-05-20.

Sponsored by Istituto Clinico Humanitas · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
70 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Glioma

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Keywords

  • HGG
03

In context

Glioma

1,425 studies on the registry are indexed under Glioma; 355 are open to participants now.

This study's enrollment of 20 is below the median of 32 across 1,085 interventional studies indexed under Glioma.

Browse Glioma studies →

Lead sponsor

Istituto Clinico Humanitas is the lead sponsor of 279 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
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:

-

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Participant)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Radiation

    To evaluate safety and feasibility of hypofractionated Intensity Modulated Radiotherapy

    Radiation: Radiation

Interventions

  • RadiationRadiation

    hypofractionated IMRT

06

What researchers measure

Primary outcomes

  1. PFS

    Progression free survival

    Time frame: one year

Secondary outcomes

  1. OS

    Overall Survival

    Time frame: one year

Other outcomes

  1. 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

    Time frame: one year

  2. QoL

    Quality of Life

    Time frame: one year

07

Study locations

1 site
  • ICH Humanitas Cancer Center
    Milan, Lombardy 20090, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02099487
Responsible party
Michele Tedeschi (M.D., Istituto Clinico Humanitas) — Principal investigator
First posted
Mar 31, 2014
Start date
Jul 2013
Primary completion
May 2016
Completion
May 2016
Last update
May 20, 2016

Study contacts

Piera Navarria, MD
study director · Humanitas Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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