Clinical trial · Interventional
Prospective Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children
Prospective Randomized Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Pediatric Diffuse Brainstem Glioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This Trial offers a reduction in patient burden, which is especially preferable in children with a poor compliance and poor performance status. This prospective randomized trial was extension to the previous controlled prospective study performed in Children's Cancer Hospital, Egypt and registered at clinicaltrials.com (NCT01635140). The ultimate aim of this work is to demonstrate noninferiority of the hypofractionated regimens relative to the conventional regimen in a controlled randomized clinical study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Brain Stem Glioma | Childhood Brain Stem Glioma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Arm (3) | Radiation | — | UNRESOLVED |
| Hypofractionated Arm (1) | Radiation | — | UNRESOLVED |
| Hypofractionated Arm (2) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Hypofractionated Arm (1)
- description
- A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week , by conformal radiotherapy sparing of the supratentorial brain. The planning target volume included the tumor as defined by the T2-weighted MRI images with a margin of 1.5-2.0 cm. Margins were adjusted for bony structures and tentorium. With exception of steroids, no neoadjuvant, concomitant, or adjuvant systemic treatment was allowed
- interventionNames
- Radiation: Hypofractionated Arm (1)
- type
- EXPERIMENTAL
- label
- Hypofractionated Arm (2)
- description
- The same planning and treatment procedures will be performed. The total dose will be 4500 cGy in 15 fractions in 3 weeks; giving 300 cGy per fraction.
- interventionNames
- Radiation: Hypofractionated Arm (2)
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available