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

Phase 2

Completed

• Conditions: Glioma
• Interventions: Radiation: Radiation

• Registration Number: NCT02099487
• Lead Sponsor: Istituto Clinico Humanitas

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.

Study Timeline

• Study Start: 2013-07
• Status Verified: 2014-01
• Study First Submitted: 2014-01-24
• Study First Submitted QC: 2014-03-25
• Study First Posted: 2014-03-31
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-19
• Last Update Posted: 2016-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiation	Radiation	To evaluate safety and feasibility of hypofractionated Intensity Modulated Radiotherapy

Primary Outcome Measures

Name	Time	Method
PFS	one year	Progression free survival

Secondary Outcome Measures

Name	Time	Method
OS	one year	Overall Survival

Trial Locations

Locations (1)

ICH Humanitas Cancer Center; 🇮🇹 Milan, Lombardia, Italy