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NCT Number: NCT01878266

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

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.

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Key information

Conditions

Pediatric Brain Stem Glioma Brain Diseases Brain Neoplasms Brain Stem Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Diffuse Intrinsic Pontine Glioma Glioma Infratentorial Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Cancer Hospital Egypt 57357

Cairo, 11441, Egypt

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypofractionated Arm (1)

Radiation

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

Hypofractionated Arm (2)

Radiation

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

Conventional Arm (3)

Radiation

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

Primary outcomes

  1. Median overall-free survival

    Time frame: 3 years

Secondary outcomes

  1. Progression-free survival

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Children's Cancer Hospital Egypt 57357

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 14, 2013
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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