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

Not Applicable

Completed

• Conditions: Pediatric Brain Stem Glioma
• Interventions: Radiation: Hypofractionated Arm (2); Radiation: Hypofractionated Arm (1); Radiation: Conventional Arm (3)

• Registration Number: NCT01878266
• Lead Sponsor: Children's Cancer Hospital Egypt 57357

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-06-09
• Study First Submitted QC: 2013-06-12
• Study First Posted: 2013-06-14
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypofractionated Arm (2)	Hypofractionated Arm (2)	The same planning and treatment procedures will be performed. The total dose will be 4500 cGy in 15 fractions in 3 weeks; giving 300 cGy per fraction.
Hypofractionated Arm (1)	Hypofractionated Arm (1)	A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week , by conformal radiotherapy sparing of the supratentorial brain. The planning target volume included the tumor as defined by the T2-weighted MRI images with a margin of 1.5-2.0 cm. Margins were adjusted for bony structures and tentorium. With exception of steroids, no neoadjuvant, concomitant, or adjuvant systemic treatment was allowed
Conventional Arm (3)	Conventional Arm (3)	The same planning and treatment procedures will be performed with 54.0 Gy in 30 fractions giving 1.8 Gy per fraction.

Primary Outcome Measures

Name	Time	Method
Median overall-free survival	3 years

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	3 years

Trial Locations

Locations (1)

Children's Cancer Hospital Egypt 57357; 🇪🇬 Cairo, Egypt