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Completed

NCT Number: NCT02567539

Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma

The study is aimed to evaluate efficacy and safety of re-irradiation for patients with recurrent high grade gliomas after other treatment.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

About this study

Investigators designed this study of a re-irradiation with single radiosurgery or hypofractionated intensity modulated radiation therapy (IMRT) with or without temozolomide.

Objective of the study is evaluating efficacy and safety of re-irradiation for patients with recurrent high grade gliomas after other treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18 years
  • Karnosky performance status (KPS) ≥70
  • Patients aged >70 years with KPS ≥80
  • Histopathologically confirmed grade III-IV glioma
  • Estimated survival ≥ 3 months
  • Any Tumor volume
  • Unifocal tumor
  • Interval time from previous radiotherapy ≥ 6mesi
  • Normal liver, Kidney and bone marrow function
  • Written informed consent

Exclusion criteria

  • KPS < 70
  • Multifocal tumor
  • Other primary cancer
  • Pregnant women

Treatment and study plan

IMRT with or without radiosensitive therapy

Radiation

Re-irradiation with hypofractionated intensity modulated radiation therapy (IMRT), using VMAT RapidArc

Other names: Hypofractionated Stereotactic Radiation

Radiosensitive therapy

Drug

Radiosensitive therapy with Temozolomide

Other names: Chemotherapy

Primary outcomes

  1. Progression free of participants

    Time frame: 4 years

  2. Overall survival of participants

    Time frame: 4 years

Secondary outcomes

  1. Incidence of radionecrosis

    Time frame: 3 months

  2. Questionnaire assessment of neurocognitive function

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

Phase II Study of Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Oct 5, 2015
Registry last updated
Sep 15, 2022

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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