Clinical Trial: Prospective Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Prospective Randomized Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Pediatric Diffuse Brainstem Glioma
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 Summary: 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.
Sponsor: Children's Cancer Hospital Egypt 57357
Current Primary Outcome: Median overall-free survival [ Time Frame: 3 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Progression-free survival [ Time Frame: 3 years ]
Original Secondary Outcome: Same as current
Information By: Children's Cancer Hospital Egypt 57357
Dates:
Date Received: June 9, 2013
Date Started: February 2013
Date Completion: May 2016
Last Updated: January 11, 2016
Last Verified: January 2016