Prospective Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Randomized Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Pediatric Diffuse Brainstem Glioma

Conditions
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Pediatric Brain Stem Glioma

Intervention / Treatment
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* Radiation: Hypofractionated Arm (1)
* Radiation: Hypofractionated Arm (2)
* Radiation: Conventional Arm (3)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed patients with a diffuse intrinsic brainstem glioma Aged 2-18years, Have symptoms for less than 3 months and at least two findings of the neurologic triad: cranial nerve deficits, ataxia, or long tract signs. 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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypofractionated Arm (1)<br>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 | Radiation: Hypofractionated Arm (1)<br>* A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week<br>|
| Experimental: Hypofractionated Arm (2)<br>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. | Radiation: Hypofractionated Arm (2)<br>* The total dose to 4500 cGy in 15 fractions in 3 weeks<br>|
| Other: Conventional Arm (3)<br>The same planning and treatment procedures will be performed with 54.0 Gy in 30 fractions giving 1.8 Gy per fraction. | Radiation: Conventional Arm (3)<br>* A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.Conventional arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median overall-free survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diffuse Intrinsic Pontine Glioma (DIPG), Hypofractionated Radiotherapy, Radiotherapy, Median survival