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Clinical Trials/NCT02099487
NCT02099487
Completed
Phase 2

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

Istituto Clinico Humanitas1 site in 1 country20 target enrollmentJuly 2013
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ConditionsGlioma

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Glioma
Sponsor
Istituto Clinico Humanitas
Enrollment
20
Locations
1
Primary Endpoint
PFS
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
May 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Istituto Clinico Humanitas
Responsible Party
Principal Investigator
Principal Investigator

Michele Tedeschi

M.D.

Istituto Clinico Humanitas

Eligibility Criteria

Inclusion Criteria

  • •Patients aged ≥ 70 years
  • •Karnosky performance status (KPS) ≤60
  • •Histologically confirmed HGG after tumor biopsy
  • •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:

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

PFS

Time Frame: one year

Progression free survival

Secondary Outcomes

  • OS(one year)

Study Sites (1)

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