Prospective Randomized Phase II Trial of Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- progression free survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Stereotactic hypofractionated RT 5x5Gy (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.
Intervention: Stereotactic hypofractionated RT 5x7Gy (Radiation)
Outcomes
Primary Outcomes
progression free survival
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
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 attributable to other causes other than the tumor or reduction in corticosteroid dose
Secondary Outcomes
- local control(from date of randomization until date of local progression, assessed up to 48 months)
- toxicity(from date of randomization until death, assessed up to 48 months)
- overall survival(from date of randomization until death from any cause, assessed up to 48 months)
- quality of life(from date of randomization until last follow-up, assessed up to a period of 48 months)
Investigators
Andre Tsin Chih Chen
Medical Doctor
University of Sao Paulo