Hypofractionated Radiotherapy Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children

Pediatric Brain Stem Glioma Clinical Trial

Official title:

Prospective Randomized Trial of Hypofractionated Radiotherapy Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635140
• Other study ID #: CCHE-BT001
• Status: Completed
• Phase: Phase 3
• First received: June 28, 2012
• Last updated: July 6, 2012
• Start date: May 2010
• Est. completion date: July 2011

Study information

• Verified date: July 2012
• Source: Children's Cancer Hospital Egypt 57357
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hypofractionated radiotherapy reduce the patient and family burden through decreasing the overall treatment time. This study is to evaluate the clinical end results of the hypofractionated radiotherapy in DIPG compared to the conventional treatment. The non-inferiority of the hypofractionated radiotherapy will result in decrease the hospital, stay or engagement, for more than its half with the same results.

Description:

In lack of open study protocols aiming to increase cure rate in pediatric diffuse intrinsic pontine glioma (DIPG), the investigators examined a hypofractionated radiotherapy regimen up to a dose of 39Gy in 13 fractions, completed in 2.5-3 weeks, instead of 6 weeks.

This schedule offers a reduction in patient burden, especially preferable in children with a poor compliance and performance status. The non-inferiority of the hypofractionated regimen in its clinical end-results, with the reduction of the overall treatment time to less than its half will decrease the burden for the patient, his/her family and the treating department. This will be considered as added value without compromising the survival or increasing side effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Newly diagnosed patients with a diffuse intrinsic brainstem glioma, ages 3-18years, were eligible for this protocol.

2. Patients were required to have symptoms for less than 3 months and at least two findings of the neurologic triad: cranial nerve deficits, ataxia, or long tract signs.

3. No performance criteria were required for entry onto the study.

4. The diagnosis of DIPG based on a high-quality, gadolinium- enhanced magnetic resonance imaging (MRI) scan containing at least T1, T2 MRIs with gadolinium contrast in three series, as well as diffusion imaging.

5. Symptoms & signs of less than 3 months duration

Exclusion Criteria:

1. Children were not eligible if they had received any prior therapy other than steroid

2. The diagnosis of exophytic brainstem glioma

Related Conditions & MeSH terms

• Glioma
• Pediatric Brain Stem Glioma

Intervention

Radiation:
• Hypofractionated radiotherapy
A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week
• Conventional arm
A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.

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
Primary	Progression-free survival		3 Years