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

Children's Cancer Hospital Egypt 57357119 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

119

Conditions

Pediatric Brain Stem Glioma

Interventions

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Median overall-free survival

Time frame: 3 years

Secondary Outcomes

Progression-free survival