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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01878266

Enrollment

119

Registered

2013-06-14

Start date

2013-02-28

Completion date

2016-05-31

Last updated

2021-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Brain Stem Glioma

Keywords

Diffuse Intrinsic Pontine Glioma (DIPG), Hypofractionated Radiotherapy, Radiotherapy, Median survival

Brief summary

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

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.

Interventions

RADIATIONHypofractionated Arm (1)

A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week

RADIATIONHypofractionated Arm (2)

The total dose to 4500 cGy in 15 fractions in 3 weeks

RADIATIONConventional Arm (3)

A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.Conventional arm

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Median overall-free survival	3 years

Secondary

Measure	Time frame
Progression-free survival	3 years

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026