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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Recurrent Glioblastoma Multiforme

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

progression free survival

Outcome 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

Outcome 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

Safety Issue:

No

Principal Investigator

Andre T Chen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital das Clinicas da Faculdade de Medicina da USP

Authority:

Brazil: National Committee of Ethics in Research

Study ID:

RT-01/2011

NCT ID:

NCT01464177

Start Date:

October 2011

Completion Date:

October 2015

Related Keywords:

  • Recurrent Glioblastoma Multiforme
  • malignant glioma
  • glioblastoma
  • radiotherapy
  • randomized
  • Glioblastoma

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