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

This study is currently recruiting participants.
Verified May 2016 by Andre Tsin Chih Chen, University of Sao Paulo
Sponsor:
ClinicalTrials.gov Identifier:
NCT01464177
First Posted: November 3, 2011
Last Update Posted: May 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Andre Tsin Chih Chen, University of Sao Paulo
  Purpose

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.


Condition Intervention Phase
Recurrent Glioblastoma Multiforme Radiation: Stereotactic hypofractionated RT 5x5Gy Radiation: Stereotactic hypofractionated RT 5x7Gy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Phase II Trial of Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme

Resource links provided by NLM:


Further study details as provided by Andre Tsin Chih Chen, University of Sao Paulo:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • overall survival [ Time Frame: 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 ]
  • 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.

  • 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


Estimated Enrollment: 40
Study Start Date: October 2011
Estimated Study Completion Date: October 2021
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464177


Contacts
Contact: Andre T Chen, M.D. 55-11-2661-7081 andre.chen@hc.fm.usp.br
Contact: Eduardo Weltman, M.D./PhD 55-11-2661-7089 eweltman@einstein.br

Locations
Brazil
Hospital das Clinicas da Faculdade de Medicina da USP Recruiting
Sao Paulo, SP, Brazil, 05403-010
Contact: Andre T Chen, M.D.    55-11-2661-7081    andre.chen@hc.fm.usp.br   
Principal Investigator: Andre T Chen, M.D.         
Sponsors and Collaborators
Andre Tsin Chih Chen
Investigators
Principal Investigator: Andre T Chen, M.D. Hospital das Clinicas da Faculdade de Medicina da USP
  More Information

Publications:

Responsible Party: Andre Tsin Chih Chen, Medical Doctor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01464177     History of Changes
Other Study ID Numbers: RT-01/2011
First Submitted: October 25, 2011
First Posted: November 3, 2011
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by Andre Tsin Chih Chen, University of Sao Paulo:
malignant glioma
glioblastoma
radiotherapy
randomized

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue