NCT01635140

Hypofractionated Radiotherapy Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Children's Cancer Hospital Egypt 57357 · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pediatric Brain Stem Glioma

Interventions

Type	Name	Description
RADIATION	Hypofractionated radiotherapy	A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week
RADIATION	Conventional arm	A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2012-07-09
• Last updated: 2012-07-09

Locations

1 site across 1 country: Egypt