Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma

September 14, 2022 updated by: Michele Tedeschi, Istituto Clinico Humanitas

Phase II Study of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milan
      • Rozzano, Milan, Italy, 20089
        • Istituto Clinico Humanitas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Recurrent high grade glioma
IMRT with or without radiosensitive therapy
Radiation: IMRT with or without radiosensitive therapy
Re-irradiation with hypofractionated intensity modulated radiation therapy (IMRT), using VMAT RapidArc
Other Names:
  • Hypofractionated Stereotactic Radiation
Drug: Radiosensitive therapy
Radiosensitive therapy with Temozolomide
Other Names:
  • Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free of participants
Time Frame: 4 years
4 years
Overall survival of participants
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of radionecrosis
Time Frame: 3 months
3 months
Questionnaire assessment of neurocognitive function
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Investigators

  • Principal Investigator: Piera Navarria, MD, Istituto Clinico Humanitas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2015

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

September 28, 2015

First Submitted That Met QC Criteria

October 2, 2015

First Posted (Estimate)

October 5, 2015

Study Record Updates

Last Update Posted (Actual)

September 15, 2022

Last Update Submitted That Met QC Criteria

September 14, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1394

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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