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

This study is currently recruiting participants.
Verified September 2012 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Andre Tsin Chih Chen, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01464177
First received: October 25, 2011
Last updated: September 27, 2012
Last verified: September 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • local control [ Time Frame: from date of randomization until date of local progression, assessed up to 48 months ] [ Designated as safety issue: No ]
  • toxicity [ Time Frame: from date of randomization until death, assessed up to 48 months ] [ Designated as safety issue: Yes ]
    • 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 ] [ Designated as safety issue: No ]
    • 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 2015
Estimated Primary Completion Date: October 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: October 25, 2011
Last Updated: September 27, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by 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

ClinicalTrials.gov processed this record on April 17, 2014