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

Pediatric Brain Stem Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878266
• Other study ID #: CCHE-BT002
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: May 2016

Study information

• Verified date: August 2021
• Source: Children's Cancer Hospital Egypt 57357
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Pediatric Brain Stem Glioma

Intervention

Radiation:
• Hypofractionated Arm (1)
A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week
• Hypofractionated Arm (2)
The total dose to 4500 cGy in 15 fractions in 3 weeks
• Conventional Arm (3)
A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.Conventional arm

Locations

Country	Name	City	State
Egypt	Children's Cancer Hospital Egypt 57357	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Children's Cancer Hospital Egypt 57357

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median overall-free survival		3 years
Secondary	Progression-free survival		3 years