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Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01464177
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Andre Tsin Chih Chen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Andre T Chen, M.D. / PhD
Principal Investigator Affiliation Hospital das Clinicas da Faculdade de Medicina da USP
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Completed
Countries Brazil
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Recurrent Glioblastoma Multiforme
Arms & Interventions

Arms

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.

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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sao Paulo, SP, Brazil

Status

Address

Hospital das Clinicas da Faculdade de Medicina da USP

Sao Paulo, SP, 05403-010