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

Istituto Clinico Humanitas

Status and phase: Completed; Phase 2

Conditions: Glioma

Treatments: Radiation: Radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT02099487

1139

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 70+ years old

Volunteers: No 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:

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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20 participants in 1 patient group

Radiation

Experimental group

Description:

To evaluate safety and feasibility of hypofractionated Intensity Modulated Radiotherapy

Treatment:

Radiation: Radiation