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

Primary Purpose

Recurrent Glioblastoma Multiforme

Status
Active
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Stereotactic hypofractionated RT 5x5Gy
Stereotactic hypofractionated RT 5x7Gy
Sponsored by
Andre Tsin Chih Chen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Glioblastoma Multiforme focused on measuring malignant glioma, glioblastoma, radiotherapy, randomized

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital das Clinicas da Faculdade de Medicina da USP

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Stereotactic hypofractionated RT 5x5Gy

Stereotactic hypofractionated RT 5x7Gy

Arm Description

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 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.

Outcomes

Primary Outcome Measures

progression free survival
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
local control
toxicity
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
quality of life measured by the "FACT Br" questionary will be assessed every 2 months

Full Information

First Posted
October 25, 2011
Last Updated
December 15, 2021
Sponsor
Andre Tsin Chih Chen
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1. Study Identification

Unique Protocol Identification Number
NCT01464177
Brief Title
Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme
Acronym
GBM Hypo RT
Official Title
Prospective Randomized Phase II Trial of Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2011 (Actual)
Primary Completion Date
July 2021 (Actual)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andre Tsin Chih Chen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Glioblastoma Multiforme
Keywords
malignant glioma, glioblastoma, radiotherapy, randomized

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic hypofractionated RT 5x5Gy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Stereotactic hypofractionated RT 5x7Gy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic hypofractionated RT 5x5Gy
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
Stereotactic hypofractionated RT 5x7Gy
Intervention Description
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 Outcome Measure Information:
Title
progression free survival
Description
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
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
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
from date of randomization until death from any cause, assessed up to 48 months
Title
local control
Time Frame
from date of randomization until date of local progression, assessed up to 48 months
Title
toxicity
Description
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.
Time Frame
from date of randomization until death, assessed up to 48 months
Title
quality of life
Description
quality of life measured by the "FACT Br" questionary will be assessed every 2 months
Time Frame
from date of randomization until last follow-up, assessed up to a period of 48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre T Chen, M.D. / PhD
Organizational Affiliation
Hospital das Clinicas da Faculdade de Medicina da USP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas da Faculdade de Medicina da USP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
15758009
Citation
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Results Reference
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PubMed Identifier
19269895
Citation
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Results Reference
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PubMed Identifier
21159396
Citation
Niyazi M, Siefert A, Schwarz SB, Ganswindt U, Kreth FW, Tonn JC, Belka C. Therapeutic options for recurrent malignant glioma. Radiother Oncol. 2011 Jan;98(1):1-14. doi: 10.1016/j.radonc.2010.11.006. Epub 2010 Dec 13.
Results Reference
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PubMed Identifier
9069312
Citation
Shepherd SF, Laing RW, Cosgrove VP, Warrington AP, Hines F, Ashley SE, Brada M. Hypofractionated stereotactic radiotherapy in the management of recurrent glioma. Int J Radiat Oncol Biol Phys. 1997 Jan 15;37(2):393-8. doi: 10.1016/s0360-3016(96)00455-5.
Results Reference
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PubMed Identifier
15924621
Citation
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Citation
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Citation
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PubMed Identifier
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Citation
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Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme

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