Skip to main content
OpenTrials
Completed

NCT Number: NCT01464177

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Recurrent Glioblastoma Multiforme Astrocytoma Glioblastoma 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

Phase 2

Primary location

Hospital das Clinicas da Faculdade de Medicina da USP

São Paulo, 05403-010, Brazil

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Stereotactic hypofractionated RT 5x5Gy

Radiation

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

Stereotactic hypofractionated RT 5x7Gy

Radiation

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.

Primary outcomes

  1. 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 attributable to other causes other than the tumor or reduction in corticosteroid dose

Secondary outcomes

  1. overall survival

    Time frame: from date of randomization until death from any cause, assessed up to 48 months

  2. local control

    Time frame: from date of randomization until date of local progression, assessed up to 48 months

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Andre Tsin Chih Chen

Other

Registry information

Official study title

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

Acronym: GBM Hypo RT

Important dates

Study start
2011
Primary completion
2021
Study completion
2024
First posted
Nov 3, 2011
Registry last updated
Dec 9, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.