Prospective Randomized Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Pediatric Diffuse Brainstem Glioma
Phase 3
2 Years
18 Years
2 Years
18 Years
Open (Enrolling)
Both
Pediatric Brain Stem Glioma
Both
Pediatric Brain Stem Glioma
Trial Information
Prospective Randomized Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Pediatric Diffuse Brainstem Glioma
In this study will add a third arm in which we will increase in the total dose to 4500 cGy
in 15 fractions in 3 weeks may lead to improvement in Over-all survival or Progression-Free
Survival.
Inclusion Criteria:
1. Newly diagnosed patients with a diffuse intrinsic brainstem glioma
2. Aged 2-18years,
3. Have symptoms for less than 3 months and at least two findings of the neurologic
triad: cranial nerve deficits, ataxia, or long tract signs.
4. No performance criteria were required for entry onto the study.
Exclusion Criteria:
- Children were not eligible if they had received any prior therapy other than steroids
Treatment
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
Authority:
Egypt: Institutional Review Board
Study ID:
CCHE-BT002
NCT ID:
NCT01878266
Start Date:
February 2013
Completion Date:
December 2013
Related Keywords:
- Pediatric Brain Stem Glioma
- Diffuse Intrinsic Pontine Glioma (DIPG)
- Hypofractionated Radiotherapy
- Radiotherapy
- Median survival
- Glioma
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