Prospective Randomized Trial of Hypofractionated Radiotherapy Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children.
3 Years
18 Years
Both
Pediatric Brain Stem Glioma
Trial Information
Prospective Randomized Trial of Hypofractionated Radiotherapy Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children.
In lack of open study protocols aiming to increase cure rate in pediatric diffuse intrinsic
pontine glioma (DIPG), the investigators examined a hypofractionated radiotherapy regimen up
to a dose of 39Gy in 13 fractions, completed in 2.5-3 weeks, instead of 6 weeks.
This schedule offers a reduction in patient burden, especially preferable in children with a
poor compliance and performance status. The non-inferiority of the hypofractionated regimen
in its clinical end-results, with the reduction of the overall treatment time to less than
its half will decrease the burden for the patient, his/her family and the treating
department. This will be considered as added value without compromising the survival or
increasing side effects.
Inclusion Criteria:
1. Newly diagnosed patients with a diffuse intrinsic brainstem glioma, ages 3-18years,
were eligible for this protocol.
2. Patients were required to have symptoms for less than 3 months and at least two
findings of the neurologic triad: cranial nerve deficits, ataxia, or long tract
signs.
3. No performance criteria were required for entry onto the study.
4. The diagnosis of DIPG based on a high-quality, gadolinium- enhanced magnetic
resonance imaging (MRI) scan containing at least T1, T2 MRIs with gadolinium contrast
in three series, as well as diffusion imaging.
5. Symptoms & signs of less than 3 months duration
Exclusion Criteria:
1. Children were not eligible if they had received any prior therapy other than steroid
2. The diagnosis of exophytic brainstem glioma
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Median overall-free survival
Outcome Time Frame:
3 years
Safety Issue:
Yes
Principal Investigator
Mohamed s zaghloul, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Children's Cancer Hospital Egypt 57357
Authority:
Egypt: Institutional Review Board
Study ID:
CCHE-BT001
NCT ID:
NCT01635140
Start Date:
May 2010
Completion Date:
July 2011
Related Keywords:
- Pediatric Brain Stem Glioma
- DIPG
- Hypofractionated Radiotherapy
- Radiotherapy
- Median survival
- Glioma
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