Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme (GBM Hypo RT)

December 6, 2023 updated by: Andre Tsin Chih Chen

Prospective Randomized Phase II Trial of Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme

Glioblastoma multiforme (GBM) is the most common primary brain tumor in adults. The treatment comprises maximal safe resection followed by radiotherapy and chemotherapy. Despite appropriate management, 90% of the patients will develop relapse or progression. After progression, the median survival is 5.2 months (Stupp, 2009).

The treatment of GBM relapse remains investigational. Reirradiation is an option in selected cases.

The objective of this study is to compare 2 schemes of stereotactic hypofractionated radiotherapy in the management of recurrent GBM.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

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

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05403-010
        • Hospital Das Clinicas Da Faculdade De Medicina Da USP

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

Description

Inclusion Criteria:

  • 18 years of age or older
  • KPS equal or greater than 60
  • Anatomopathological confirmation of GBM
  • Previous RT with therapeutic doses
  • At least 5 months from the end of RT course
  • Not a candidate to surgical resection
  • Patients with partial resection after resection of recurrent GBM will be allowed
  • Patients with local progression after resection of recurrent GBM will be allowed
  • Lesion with a maximal 150cc volume, as defined by enhancing portion in contrast enhanced MRI
  • Hemoglobin levels (Hb) equal or greater than 10ng/dl. Blood transfusions to correct the Hb will be allowed.

Exclusion Criteria:

  • Important comorbidities
  • Concomitant chemotherapy
  • Contraindication to MRI
  • Brainstem glioma

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Stereotactic hypofractionated RT 5x5Gy

Stereotactic hypofractionated radiation therapy delivered as follows:

  • Gross tumor volume (GTV) equals enhancement area in T1 contrast enhanced MRI.
  • Planning tumor volume (PTV) equals GTV plus 3mm margin.
  • the dose of radiation will be 25Gy delivered in 5 fractions.1 fraction per day, non consecutive days in a maximum period of 10 working days.
  • RT to begin in a maximum of 2 weeks after randomization.
Radiation: Stereotactic hypofractionated RT 5x5Gy

Stereotactic hypofractionated radiation therapy delivered as follows:

  • Gross tumor volume (GTV) equals enhancement area in T1 contrast enhanced MRI.
  • Planning tumor volume (PTV) equals GTV plus 3mm margin.
  • The dose of radiation will be 25Gy delivered in 5 fractions.1 fraction per day, non consecutive days in a maximum period of 10 working days.
  • RT to begin in a maximum of 2 weeks after randomization
Experimental: Stereotactic hypofractionated RT 5x7Gy

Stereotactic hypofractionated radiation therapy delivered as follows:

  • Gross tumor volume (GTV) equals enhancement area in T1 contrast enhanced MRI.
  • Planning tumor volume (PTV) equals GTV plus 3mm margin.
  • the dose of radiation will be 35Gy delivered in 5 fractions.1 fraction per day, non consecutive days in a maximum period of 10 working days.
  • RT to begin in a maximum of 2 weeks after randomization.
Radiation: Stereotactic hypofractionated RT 5x7Gy

Stereotactic hypofractionated radiation therapy delivered as follows:

  • Gross tumor volume (GTV) equals enhancement area in T1 contrast enhanced MRI.
  • Planning tumor volume (PTV) equals GTV plus 3mm margin.
  • The dose of radiation will be 35Gy delivered in 5 fractions.1 fraction per day, non consecutive days in a maximum period of 10 working days.
  • RT to begin in a maximum of 2 weeks after randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: from date of randomization until date of first documented progression or death from any cause, which ever comes first, assessed up to 48 months

progression free survival as defined by the "Response Assesment in Neuro Oncology Working Group"(Wen, 2010). Briefly progression is defined as:

  • increase in 25% of the product of perpendicular diameters of enhancing lesions
  • significant increase in T2/Flair non enhancing component
  • appearance of new lesions
  • clinical deterioration not atributable to other causes other than the tumor or reduction in corticosteroid dose
from date of randomization until date of first documented progression or death from any cause, which ever comes first, assessed up to 48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: from date of randomization until death from any cause, assessed up to 48 months
from date of randomization until death from any cause, assessed up to 48 months
local control
Time Frame: from date of randomization until date of local progression, assessed up to 48 months
from date of randomization until date of local progression, assessed up to 48 months
toxicity
Time Frame: from date of randomization until death, assessed up to 48 months
  • toxicity scored by the Common Terminology of Adverse Events version 4
  • will be assessed every 2 months or in case of patient hospitalization or visit to the E.R.
from date of randomization until death, assessed up to 48 months
quality of life
Time Frame: from date of randomization until last follow-up, assessed up to a period of 48 months
  • quality of life measured by the "FACT Br" questionary
  • will be assessed every 2 months
from date of randomization until last follow-up, assessed up to a period of 48 months

Collaborators and Investigators

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

Sponsor

Andre Tsin Chih Chen

Investigators

  • Principal Investigator: Andre T Chen, M.D. / PhD, Hospital Das Clinicas Da Faculdade De Medicina Da USP

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)

October 1, 2011

Primary Completion (Actual)

July 1, 2021

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

October 25, 2011

First Submitted That Met QC Criteria

October 31, 2011

First Posted (Estimated)

November 3, 2011

Study Record Updates

Last Update Posted (Actual)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT-01/2011

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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