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

NCT01878266 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2021-08-09

No results posted yet for this study

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.

Conditions

  • Pediatric Brain Stem Glioma

Interventions

RADIATION

Hypofractionated Arm (1)

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

RADIATION

Hypofractionated Arm (2)

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

RADIATION

Conventional Arm (3)

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

Sponsors & Collaborators

  • Children's Cancer Hospital Egypt 57357

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01878266 on ClinicalTrials.gov