Pediatric Brain Stem Glioma
Conditions
Keywords
DIPG, Hypofractionated Radiotherapy, Radiotherapy, Median survival
Brief summary
Hypofractionated radiotherapy reduce the patient and family burden through decreasing the overall treatment time. This study is to evaluate the clinical end results of the hypofractionated radiotherapy in DIPG compared to the conventional treatment. The non-inferiority of the hypofractionated radiotherapy will result in decrease the hospital, stay or engagement, for more than its half with the same results.
Detailed description
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.
Interventions
RADIATIONHypofractionated radiotherapy
A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week
RADIATIONConventional arm
A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.
Sponsors
Children's Cancer Hospital Egypt 57357
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median overall-free survival | 3 years |
| Progression-free survival | 3 Years |
Countries
Egypt
Outcome results
None listed