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

Andre Tsin Chih Chen

Status and phase: Completed; Phase 2

Conditions: Recurrent Glioblastoma Multiforme

Treatments: Radiation: Stereotactic hypofractionated RT 5x5Gy; Radiation: Stereotactic hypofractionated RT 5x7Gy

Study type: Interventional

Funder types: Other

Identifiers

NCT01464177

RT-01/2011

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Stereotactic hypofractionated RT 5x5Gy

Active Comparator group

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.

Treatment:

Radiation: Stereotactic hypofractionated RT 5x5Gy

Stereotactic hypofractionated RT 5x7Gy

Experimental group

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.

Treatment:

Radiation: Stereotactic hypofractionated RT 5x7Gy