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Completed

NCT Number: NCT02099487

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

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.

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Key information

Conditions

Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ICH Humanitas Cancer Center

Milan, Lombardy, 20090, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Radiation

Radiation

hypofractionated IMRT

Primary outcomes

  1. PFS

    Time frame: one year

    Progression free survival

Secondary outcomes

  1. OS

    Time frame: one year

    Overall Survival

Other outcomes

  1. Toxicity

    Time frame: 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

  2. QoL

    Time frame: one year

    Quality of Life

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 31, 2014
Registry last updated
May 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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