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Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme

NCT01464177 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-12-09

No results posted yet for this study

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.

Conditions

  • Recurrent Glioblastoma Multiforme

Interventions

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

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.

Sponsors & Collaborators

  • Andre Tsin Chih Chen

    lead OTHER

Principal Investigators

  • Andre T Chen, M.D. / PhD · Hospital das Clinicas da Faculdade de Medicina da USP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2021-07-31
Completion
2024-08-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01464177 on ClinicalTrials.gov